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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1041 | Diagnostic Test: serology test for COVID-19 Wiki | 0.35 |
| drug1045 | Diagnostic test Covid-19 Wiki | 0.35 |
| drug2902 | Risankizumab Wiki | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug958 | Cytochrome P450 (CYP) Substrates Wiki | 0.35 |
| drug1036 | Dexmethylphenidate Wiki | 0.35 |
| drug3592 | Upadacitinib (ABT-494) Wiki | 0.35 |
| drug1039 | Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta Wiki | 0.35 |
| drug878 | Continuation of anti-TNF treatment Wiki | 0.35 |
| drug1074 | Discontinuation of anti-TNF treatment Wiki | 0.35 |
| drug4090 | risankizumab Wiki | 0.35 |
| drug1770 | JNJ-66525433 Wiki | 0.35 |
| drug2336 | Ontamalimab Wiki | 0.35 |
| drug1046 | Diagnostic test for SARS-Cov2 for patients and health staff Wiki | 0.35 |
| drug1037 | DiaNose Wiki | 0.35 |
| drug1047 | Diagnostic test for detection of SARS-CoV-2 Wiki | 0.35 |
| drug1048 | Dialectical Behavioral Therapy (DBT) Skills Wiki | 0.35 |
| drug4038 | placebo for risankizumab Wiki | 0.25 |
| drug2505 | Placebo Wiki | 0.07 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003092 | Colitis NIH | 1.00 |
| D014456 | Ulcer NIH | 0.82 |
| D009336 | Necrosis NIH | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002583 | Colitis HPO | 1.00 |
| HP:0100279 | Ulcerative colitis HPO | 1.00 |
| HP:0002037 | Inflammation of the large intestine HPO | 0.13 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100280 | Crohn's disease HPO | 0.11 |
Navigate: Correlations HPO
There are 8 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)The 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: Endoscopic remission per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission 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: Clinical remission per Adapted Mayo Score.
Measure: Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, Remained Corticosteroid Free for 90 days, and Achieved Clinical Remission per Adapted Mayo Score 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 in Participants who were Taking Steroids at Baseline (of induction) 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: Clinical response per Adapted Mayo score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Response per Adapted Mayo Score Time: Week 52Description: Endoscopic improvement per endoscopy subscore.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Improvement Time: Week 52Description: Participants with an event that results in admission to the hospital.
Measure: Sub-Study 1: Percentage of Participants with Hospitalization Time: Through Week 52Description: The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.
Measure: Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) Time: Week 0 to Week 52Description: Histologic remission per Geboes Score.
Measure: Sub-Study 1: Percentage of Participants with Histologic Remission 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: 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 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: Week 0 to 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: The SFS, RBS, and endoscopic subscore describe disease severity.
Measure: Sub-Study 1: Percentage of Participants with Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and Endoscopic Subscore of 0 Time: At Week 52Description: The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.
Measure: Sub-Study 1: Percentage of Participants with Stool Frequency Subscore (SFS) ≤ 1 Time: Through Week 52Description: The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.
Measure: Sub-Study 1: Percentage of Participants with Rectal Bleeding Subscore (RBS) = 0 Time: Through Week 52Description: The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.
Measure: Sub-study 1: Change from Baseline of Induction in Partial Adapted Mayo Score Time: Through Week 52Description: The Full Mayo Score ranges determines disease severity. A negative change in Full Mayo Score indicates improvement.
Measure: Sub-Study 1: Change in Full Mayo Score Time: Week 0 to Week 52Description: The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.
Measure: Sub-Study 1: Change in SFS Time: Week 0 to Week 52Description: The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.
Measure: Sub-Study 1: Change in RBS Time: Week 0 to Week 52Description: High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from week 0 in CRP is assessed at each time point.
Measure: Sub-Study 1: Change in High Sensitivity C-reactive Protein (hs-CRP) Time: Week 0 to Week 52Description: Stool samples were analyzed by a central laboratory for fecal calprotectin (FCP)qualitative measurement. Results are reported for participants in each category.
Measure: Sub-Study 1: Change in Fecal Calprotectin (FCP) Time: Week 0 to Week 52Description: The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as an assessment of the endoscopy findings scoring system for additional exploratory analyses.
Measure: Sub-Study 1: Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Time: At Week 52Description: The European Quality of Life 5 Dimensions (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Measure: Sub-Study 1: Change in European Quality of Life 5 Dimensions (EQ-5D-5L) Time: Week 0 to Week 52Description: The WPAI UC questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis. The self-administered questionnaire measures the effect of the participant's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
Measure: Sub-Study 1: Change in Work Productivity and Impairment Questionnaire - UC (WPAI UC) Time: Week 0 to Week 52Description: The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.
Measure: Sub-study 1: Time to Loss of Clinical Response per Partial Adapted Mayo in Patients with Response per Partial Adapted Mayo Time: At Week 0Description: The PGIS is a response scale that describes the severity of the participants disease.
Measure: Sub-Study 1: Change in Patient Global Impression of Severity (PGIS) Time: Week 0 to Week 52Description: The PGIC is a response scale. The participant will be asked by the Investigator or qualified designee to rate their change in their disease status.
Measure: Sub-Study 1: Change in Patient Global Impression of Change (PGIC) scores Time: Through Week 52Description: 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: Through Week 52Description: Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).
Measure: Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction). Time: Through Week 52Description: Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).
Measure: Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction). Time: Through Week 52Description: Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).
Measure: Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use for 90 Days and SFS ≤ 1 (and not Worse than Baseline of Induction) and RBS = 1 and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction). Time: Through Week 52Description: The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.
Measure: Sub-Study 3: Percentage of Participants with Clinical Response per Partial Adapted Mayo Score Time: Through Week 300Description: Clinical remission per Adapted Mayo Score.
Measure: Sub-Study 3: Percentage of Participants with Clinical Remission per Adapted Mayo Score with Endoscopy Time: Through Week 300Description: Clinical response per Adapted Mayo score.
Measure: Sub-Study 3: Percentage of Participants with Clinical Response per Adapted Mayo Score with Endoscopy Time: Through Week 300Description: The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.
Measure: Sub-Study 3: Time to Loss of Clinical Response per Partial Mayo Score Time: Through Week 300Description: Clinical remission per Adapted Mayo Score.
Measure: Sub-Study 3: Time to Loss of Clinical Remission per Adapted Mayo Score with Endoscopy Time: Through Week 300Description: Clinical response per Adapted Mayo score.
Measure: Sub-Study 3: Time too Loss of Clinical Response per Adapted Mayo Score with Endoscopy Time: Through Week 300Description: The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS, in participants taking steroids at baseline (of induction).
Measure: Sub-Study 3: Percentage of Participants Who Discontinued Corticosteroid Use with Clinical Response per Partial Adapted Mayo Score in Participants Taking Steroids at Baseline (of Induction). Time: Through Week 300Description: Endoscopic improvement per endoscopy subscore.
Measure: Sub-Study 3: Percentage of Participants with Endoscopic Improvement Time: Through Week 300Description: Endoscopic remission per endoscopy subscore.
Measure: Sub-Study 3: Percentage of Participants with Endoscopic Remission Time: Through Week 300Description: Mucosal healing defined as endoscopic and histologic remission.
Measure: Sub-Study 3: Percentage of Participants with Mucosal Healing Time: Through Week 300Description: Histologic remission per Geboes Score.
Measure: Sub-Study 3: Percentage of Participants with Histologic Remission Time: Through Week 300Description: The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.
Measure: Sub-Study 3: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) Time: Week 0 to Week 300Description: Participants with an event that results in admission to the hospital.
Measure: Sub-Study 3: Percentage of Participants with Hospitalization Time: Through Week 300Description: Participants who underwent surgery related to UC.
Measure: Sub-Study 3: Percentage of Participants with Ulcerative Colitis (UC)-Related Surgeries Time: Through Week 300Description: 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 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time: Week 0 to Week 300Description: The SF-36 is an indicator of overall health status.
Measure: Sub-Study 3: Change in 36-Item Short Form Health Status Survey (SF-36) Time: Week 0 to Week 300Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Measure: Sub-Study 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time: Through Week 300Description: The WPAI UC questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis. The self-administered questionnaire measures the effect of the participant's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
Measure: Sub-Study 3: Change in Work Productivity and Impairment Questionnaire - UC (WPAI UC) Time: Through Week 300Description: The European Quality of Life 5 Dimensions (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Measure: Sub-Study 3: Change in European Quality of Life 5 Dimensions (EQ-5D-5L) Time: Through Week 300Description: The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.
Measure: Sub-Study 3: Change in RBS Time: Through Week 300Description: The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.
Measure: Sub-Study 3: Change in SFS Time: Through Week 300Description: Stool samples were analyzed by a central laboratory for fecal calprotectin (FCP)qualitative measurement. Results are reported for participants in each category.
Measure: Sub-Study 3: Change in Fecal Calprotectin (FCP) Time: Through Week 300Description: High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from week 0 in CRP is assessed at each time point.
Measure: Sub-Study 3: Change in High Sensitivity C-reactive Protein (hs-CRP) Time: Through Week 300Description: The PGIS is a response scale that describes the severity of the participants disease.
Measure: Sub-Study 3: Change in Patient Global Impression of Severity (PGIS) Time: Week 0 to Week 300Description: The PGIC is a response scale. The participant will be asked by the Investigator or qualified designee to rate their change in their disease status.
Measure: Sub-Study 3: Change in Patient Global Impression of Change (PGIC) scores Time: Through Week 300Description: Participants who discontinued corticosteroid use, in participants taking steroids at baseline (of induction).
Measure: Sub-Study 3: Percentage of Participants Who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of Induction). Time: Through Week 300Ulcerative 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 DaysAlphabetical 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.
Drug Reports MeSH Reports HPO Reports