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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1248 | Disulfiram Wiki | 0.43 |
| drug4654 | placebo for risankizumab Wiki | 0.35 |
| drug1230 | Digital oximeter monitoring Wiki | 0.30 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1120 | Cytochrome P450 (CYP) Substrates Wiki | 0.30 |
| drug1243 | Discontinuation of anti-TNF treatment Wiki | 0.30 |
| drug1261 | Double-Blind NT-I7 Wiki | 0.30 |
| drug2709 | Ontamalimab Wiki | 0.30 |
| drug1268 | Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki | 0.30 |
| drug2057 | JNJ-66525433 Wiki | 0.30 |
| drug1026 | Continuation of anti-TNF treatment Wiki | 0.30 |
| drug1256 | Dornase Alfa Inhalation Solution Wiki | 0.30 |
| drug2026 | Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki | 0.30 |
| drug4155 | Upadacitinib (ABT-494) Wiki | 0.30 |
| drug1255 | Dornase Alfa Wiki | 0.30 |
| drug1236 | Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care Wiki | 0.30 |
| drug4709 | risankizumab Wiki | 0.30 |
| drug1237 | Direct Antigen Tests for COVID-19 Wiki | 0.30 |
| drug1262 | Double-Blind Placebo Wiki | 0.30 |
| drug1265 | Doxycycline Wiki | 0.27 |
| drug1597 | GLPG3970 Wiki | 0.21 |
| drug3373 | Risankizumab Wiki | 0.21 |
| drug4711 | risankizumab SC Wiki | 0.17 |
| drug4710 | risankizumab IV Wiki | 0.17 |
| drug3764 | Standard treatment Wiki | 0.11 |
| drug2916 | Placebo Wiki | 0.09 |
| drug3738 | Standard of care Wiki | 0.06 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003092 | Colitis NIH | 1.00 |
| D003093 | Colitis, Ulcerative NIH | 1.00 |
| D014456 | Ulcer NIH | 0.82 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100279 | Ulcerative colitis HPO | 1.00 |
| HP:0002037 | Inflammation of the large intestine HPO | 0.20 |
| HP:0100280 | Crohn's disease HPO | 0.18 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002242 | Abnormal intestine morphology HPO | 0.15 |
Navigate: Correlations HPO
There are 11 clinical trials
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
Description: Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.
Measure: Assessing Treatment-Emergent Adverse Events Time: Up to 288 WeeksThe primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF treatment after a relapse
Description: Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 2 years of randomized treatment
Measure: Proportion of patients in sustained clinical remission Time: 2 yearsDescription: Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 4 years of randomized treatment
Measure: Proportion of patients in sustained clinical remission Time: 4 yearsDescription: Relapse time
Measure: Time from randomization to relapse Time: 2 yearsDescription: Relapse time
Measure: Time from randomization to relapse Time: 4 yearsDescription: Remission, but no need to restart anti-tnf therapy
Measure: Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy Time: 2 yearsDescription: Remission, but no need to restart anti-tnf therapy
Measure: Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy Time: 4 yearsDescription: Remission after relapse
Measure: Proportion of relapse patients achieving remission after anti-TNF restart Time: 2 yearsDescription: Remission after relapse
Measure: Proportion of relapse patients achieving remission after anti-TNF restart Time: 4 yearsDescription: Adverse events
Measure: Adverse events and serious adverse events frequency and severity Time: 2 yearsDescription: Adverse events
Measure: Adverse events and serious adverse events frequency and severity Time: 4 yearsThe purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Description: Remission is defined as a composite score of patient-reported symptoms using daily ediary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Remission at Week 12 Time: Week 12Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Endoscopic Remission at Week 12 Time: Week 12Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Clinical Remission at Week 4, 8, 12 Time: Week 4, 8, 12Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Response (Composite) at Week 12 Time: Week 12Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Mucosal Healing at Week 12 Time: Week 12Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and PGA) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12 Time: Week 12Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 Time: Week 12Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Here participants with partial Mayo score <= 2 with no individual subscore >1 at the Week 4, 8, and 12 will be assessed.
Measure: Number of Participants With Partial Mayo Score Less than or Equal to (<=) 2 with no Individual Subscore Greater than (>) 1 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.
Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0 Time: Week 12Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Deep Remission at Week 12 Time: Week 12Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.
Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12 Time: Baseline, Week 8, 12Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12 Time: Baseline, Week 12Description: Incidence of hospitalizations during the entire study period will be assessed.
Measure: Incidence of Hospitalizations Time: From start of study up to follow up (Week 29)Description: Incidence of total inpatient days during the entire study period will be assessed.
Measure: Incidence of Total Inpatient Days Time: From start of study up to follow up (Week 29)The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Description: Remission is defined as a composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Remission at Week 12 Time: Week 12Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Endoscopic Remission at Week 12 Time: Week 12Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Clinical Remission at Week 4, 8, 12 Time: Week 4, 8, 12Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Response (Composite) at Week 12 Time: Week 12Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Mucosal Healing at Week 12 Time: Week 12Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12 Time: Week 12Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 Time: Week 12Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Number of participants with partial mayo score <=2 with no individual subscore >1 at the Week 4, 8, 12 will be assessed.
Measure: Number of Participants With Partial Mayo Score Less than or Equal (<=) 2 with no individual subscore Greater than (>) 1 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.
Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0 Time: Week 12Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Deep Remission at Week 12 Time: Week 12Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.
Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12 Time: Baseline, Week 8, 12Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12 Time: Baseline, Week 12Description: Incidence of hospitalizations during the entire study period will be assessed.
Measure: Incidence of Hospitalizations Time: From start of study up to follow up (Week 29)Description: Incidence of total inpatient days during the entire study period will be assessed.
Measure: Incidence of Total Inpatient Days Time: From start of study up to follow up (Week 29)Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: - Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls - Interaction between these proteins and biologics in breast milk of women with IBD - Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNFα and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.
Description: Multiplex assay will be used to measure TNFα and downstream chemokines including CCL2, CCL4, CCL7, CXCL10 in breast milk of two groups of participants (women with IBD and healthy controls). (The unit of measurement is the same for all these cytokines)
Measure: Levels of TNFα and its downstream chemokines (CCL2, CCL4, CCL7, and CXCL10) in breast milk of women with IBD and healthy controls by Multiplex assay Time: 4 yearsDescription: ELISA assay will be used to measure total and free drug levels (bound and unbound to TNFα) in breast milk of lactating women with IBD. (The unit of measurement is the same for infliximab and adalimumab).
Measure: Milk concentration of TNFα inhibitors (infliximab, adalimumab) at different time-points between two doses of medication, in lactating women with IBD by ELISA assay Time: 4 yearsDescription: The infants of women with IBD and healthy controls will be examined for cognitive development using Bayley-III
Measure: Scores on cognitive subset of Bayley Scales of Infant and Toddler development- Third Version (Bayley-III) in infants of healthy controls and women with IBD Time: 4 yearsDescription: Infants of healthy controls and women with IBD will be examined for communication and problem-solving development using the ASQ®-3. This supplementary measure is intended to provide additional data as an alternative to Bayley test under unprecedented circumstances which preclude participants to complete Bayley test at the Hospital for Sick Children
Measure: Scores on the "Problem-solving" and "Communication" subscales of The Ages and Stages Questionnaire (ASQ®-3) in infants of healthy controls and women with IBD Time: 4 yearsDescription: An estimation of the population distribution of anti-TNFα antibodies (infliximab and adalimumab) in breast milk of women with IBD will be made, using population pharmacokinetic modelling
Measure: Simulated/predicted profiles of TNFα inhibitors (infliximab, adalimumab) in breast milk in a large population of lactating women with IBD by population pharmacokinetic modelling Time: 4 yearsThe purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic.
Description: Clinical remission per Adapted Mayo Score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score Time: Week 52Description: An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measure: Sub-Study 3: Percentage of Participants with Adverse Events (AE) Time: Up to Week 300Description: Endoscopic improvement per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Improvement Time: Week 52Description: Clinical remission per full Mayo Score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline (of Induction) Time: Week 52Description: Percentage of participants who discontinued corticosteroid use, in participants taking steroids at baseline (of induction).
Measure: Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of induction). Time: Week 52Description: Clinical remission per Adapted Mayo Score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 Time: Week 52Description: Participants who discontinued corticosteroid use.
Measure: Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, Remained Corticosteroid Free for 90 days and Achieved Clinical Remission in Participants who were Taking Steroids at Baseline (of induction) Time: Week 52Description: Clinical response per Adapted Mayo Score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Response per Adapted Mayo Score Time: Week 52Description: Percentage of participants achieving histologic-endoscopic mucosal improvement.
Measure: Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement Time: Week 52Description: Endoscopic remission per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission Time: Week 52Description: Endoscopic improvement per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 Time: Week 52Description: Participants with a UC event that results in admission to the hospital.
Measure: Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC) Related Hospitalization Time: Through Week 52Description: Histologic remission per Geboes Score.
Measure: Sub-Study 1: Percentage of Participants with Histologic Remission Time: Week 52Description: Percentage of participants who reported no abdominal pain.
Measure: Sub-Study 1: Percentage of Participants who Reported No Abdominal Pain Time: Week 52Description: Percentage of participants who reported no bowel urgency.
Measure: Sub-Study 1: Percentage of Participants who Reported No Bowel Urgency Time: Week 52Description: Mucosal healing defined as endoscopic and histologic remission.
Measure: Sub-Study 1: Percentage of Participants with Mucosal Healing Time: Week 52Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time: Baseline (Week 0) to Week 52Description: Participants who underwent surgery related to UC.
Measure: Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC)-Related Surgeries Time: Through Week 52Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time: Week 0 to Week 52Description: Percentage of participants who reported no nocturnal bowel movements.
Measure: Sub-Study 1: Percentage of Participants who Reported No Nocturnal Bowel Movements Time: Week 52Description: Percentage of participants who reported no tenesmus.
Measure: Sub-Study 1: Percentage of Participants who Reported No Tenesmus Time: Week 52Description: Change in number of fecal incontinence episodes per week.
Measure: Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week Time: Baseline (Week 0) to Week 52Description: Change in number of days per week with sleep interrupted due to UC symptoms.
Measure: Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms Time: Baseline (Week 0) to Week 52Description: The SF-36 is an indicator of overall health status.
Measure: Sub-Study 1: Change in 36-Item Short Form Health Status Survey (SF-36) Time: Baseline (Week 0) to Week 52The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Description: Clinical remission per adapted Mayo Score.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants with Clinical Remission per Adapted Mayo Score Time: Week 12Description: Endoscopic improvement per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Improvement Time: Week 12Description: Clinical remission per Full Mayo Score.
Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline Time: Week 12Description: Clinical response per adapted Mayo Score.
Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score Time: Week 12Description: Week 4
Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score Time: Clinical response per Partial Adapted Mayo Score (without endoscopy).Description: Endoscopic remission per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission Time: Week 12Description: Participants with an event that results in admission to the hospital.
Measure: Sub-Study 1: Percentage of Participants with Hospitalization Time: Through Week 12Description: Mucosal healing defined as endoscopic and histologic remission.
Measure: Sub-Study 1: Percentage of Participants with Mucosal Healing Time: Week 12Description: The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
Measure: Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) Time: Baseline Through Week 12Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time: Baseline Through Week 12Description: The SF-36 is an indicator of overall health status.
Measure: Sub-Study 1: Change in Short Form-36 (SF-36) Time: Baseline Through Week 12Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time: Baseline Through Week 12Description: Participants who underwent surgery related to UC.
Measure: Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC)-related Surgeries Time: Through 12 weeksDescription: Clinical remission per Full Mayo Score.
Measure: Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline Time: Week 12Description: Clinical response per adapted Mayo Score.
Measure: Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score Time: Week 12Description: Percentage of participants who reported no abdominal pain.
Measure: Sub-Study 2: Percentage of Participants who Reported No Abdominal Pain Time: Week 12Description: Percentage of participants who reported no bowel urgency.
Measure: Sub-Study 2: Percentage of Participants who Reported No Bowel Urgency Time: Week 12Description: Endoscopic remission per endoscopy subscore.
Measure: Sub-Study 2: Percentage of Participants with Endoscopic Remission Time: Week 12Description: Endoscopic improvement per endoscopy subscore.
Measure: Sub-Study 2: Percentage of Participants with Endoscopic Improvement Time: Week 12Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Measure: Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time: Baseline Through Week 12Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Measure: Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time: Baseline Through Week 12Description: Percentage of participants with histological endoscopic improvement of the mucosa.
Measure: Sub-Study 2: Percentage of Participants with Histological Endoscopic Improvement of the Mucosa Time: Week 12Description: Percentage of participants who reported no nocturnal bowel movements.
Measure: Sub-Study 2: Percentage of Participants who Reported No Nocturnal Bowel Movements Time: Week 12Description: Percentage of participants who reported no tenesmus.
Measure: Sub-Study 2: Percentage of Participants who Reported No Tenesmus Time: Week 12Description: Change in number of fecal incontinence episodes per week.
Measure: Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week Time: Baseline Through Week 12Description: Change in number of days per week with sleep interrupted due to UC symptoms.
Measure: Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms Time: Baseline Through Week 12Description: Clinical response per partial adapted Mayo Score (without endoscopy), in participants with pancolitis at Baseline.
Measure: Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score in Participants with Pancolitis at Baseline Time: Week 12Description: Participants with an UC-related event that results in admission to the hospital.
Measure: Sub-Study 2: Percentage of Participants with Ulcerative Colitis (UC)-related Hospitalization Time: Through Week 12Description: The SF-36 is an indicator of overall health status.
Measure: Sub-Study 2: Change in Short Form-36 (SF-36) Time: Baseline Through Week 12Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD. Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide. In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Description: Maximum observed plasma concentration (Cmax) of Midazolam
Measure: Maximum Observed Plasma Concentration (Cmax) of Midazolam Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Midazolam
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Midazolam Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Midazolam
Measure: Terminal Phase Elimination Rate Constant (β) of Midazolam Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Midazolam
Measure: Terminal Phase Elimination Half-Life (t1/2) of Midazolam Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Caffeine
Measure: Maximum Observed Plasma Concentration (Cmax) of Caffeine Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Caffeine
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Caffeine Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Caffeine
Measure: Terminal Phase Elimination Rate Constant (β) of Caffeine Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Caffeine
Measure: Terminal Phase Elimination Half-Life (t1/2) of Caffeine Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Warfarin
Measure: Maximum Observed Plasma Concentration (Cmax) of Warfarin Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Warfarin
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Warfarin Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Warfarin
Measure: Terminal Phase Elimination Rate Constant (β) of Warfarin Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Warfarin
Measure: Terminal Phase Elimination Half-Life (t1/2) of Warfarin Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Omeprazole
Measure: Maximum Observed Plasma Concentration (Cmax) of Omeprazole Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Omeprazole
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Omeprazole Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Omeprazole
Measure: Terminal Phase Elimination Rate Constant (β) of Omeprazole Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Omeprazole
Measure: Terminal Phase Elimination Half-Life (t1/2) of Omeprazole Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Metoprolol
Measure: Maximum Observed Plasma Concentration (Cmax) of Metoprolol Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Metoprolol
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Metoprolol Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Metoprolol
Measure: Terminal Phase Elimination Rate Constant (β) of Metoprolol Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Metoprolol
Measure: Terminal Phase Elimination Half-Life (t1/2) of Metoprolol Time: Up to 71 DaysWhether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes
Description: The need for in-hospital colectomy or rescue therapy
Measure: Primary outcome measure: The need for in-hospital colectomy or rescue therapy Time: 3 monthsDescription: Duration and type/route of steroid use
Measure: 2.1: Duration and type/route of steroid use Time: 3 monthsDescription: 30 day colectomy free survival rates
Measure: 2.2: 30 day colectomy free survival rates Time: 3 monthsDescription: Covid-19 infection rates
Measure: 2.3: Covid-19 infection rates Time: 3 monthsDescription: Rate of Rescue therapy use
Measure: 2.4: Rate of Rescue therapy use Time: 3 monthsDescription: Duration of hospital stay
Measure: 2.5: Duration of hospital stay Time: 3 monthsDescription: Admission severity scoring
Measure: 2.6: Admission severity scoring Time: 3 monthsDescription: Readmission rates
Measure: 2.7: Readmission rates Time: 3 monthsThe purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).
Description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days will be considered as TEAE.
Measure: Part 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability Time: Up to 224 DaysDescription: Number of participants with vital sign abnormalities (temperature), pulse/heart rate, respiratory rate and blood pressure) will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Vital Sign Abnormalities Time: Up to 224 DaysDescription: Number of participants with physical examination abnormalities will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Physical Examination Abnormalities Time: Up to 224 DaysDescription: Number of participants with clinical laboratory abnormalities (serum chemistry, hematology and urinalysis) will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Clinical Laboratory Abnormalities Time: Up to 224 DaysDescription: Number of participants with ECG abnormalities will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Electrocardiogram (ECG) Abnormalities Time: Up to 224 DaysDescription: Plasma concentrations of JNJ-66525433 will be reported.
Measure: Part 1, 2 and 3: Plasma Concentrations of JNJ-66525433 Time: Up to 224 DaysDescription: Plasma concentrations of JNJ-66525433 after fasted or fed dosing will be reported.
Measure: Part 1: Plasma Concentrations of JNJ-66525433 After Fasted or Fed Dosing Time: Up to Day 14Description: Mayo scoring system is used for assessment of ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each ranges from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12, where higher score indicates severe disease.
Measure: Part 3: Mayo Score Time: Up to Day 84Description: Partial Mayo score is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, and physician's global assessment) and ranges from 0 to 9 points. Higher score indicates severe disease.
Measure: Part 3: Partial Mayo Score Time: Up to Day 70Description: Endoscopy sub-score ranges from 0 to 3 where; 0 = normal or inactive disease; 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = severe disease (spontaneous bleeding, ulceration).
Measure: Part 3: Endoscopic Subscore Time: Up to Day 84Description: IBDQ18 is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Measure: Part 3: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score Time: Days 1, 7, 14, 28, 43, 70 and 84Description: Levels of mRNA knockdown will be reported to assess target engagement in biopsy tissue by dose level over time.
Measure: Part 2 and 3: Target Engagement of Messenger Ribonucleic Acid (mRNA) Levels Time: Up to 182 DaysDescription: Tissue biopsy concentrations of JNJ-66525433 will be reported.
Measure: Part 2 and 3: Tissue Biopsy JNJ-66525433 Concentrations Time: Up to 182 DaysThe primary objective of this study is to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in participants with moderately to severely active UC.
Description: Mayo score is an instrument designed to measure disease activity of UC. Total Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, flexible sigmoidoscopy and physician's global assessment, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 12, with higher total scores indicating more severe disease.
Measure: Change From Baseline in Total Mayo Clinical Score (MCS) at Week 6 Time: Baseline and Week 6Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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