Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1045 | Diagnostic test Covid-19 Wiki | 1.00 |
| drug4038 | placebo for risankizumab Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003092 | Colitis NIH | 0.35 |
| D003093 | Colitis, Ulcerative NIH | 0.35 |
| D014456 | Ulcer NIH | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002583 | Colitis HPO | 0.35 |
| HP:0100279 | Ulcerative colitis HPO | 0.35 |
Navigate: Correlations HPO
There is one clinical trial.
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 300Alphabetical 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