Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug1255 | Dornase Alfa Wiki | 1.00 |
drug4654 | placebo for risankizumab Wiki | 0.58 |
Name (Synonyms) | Correlation | |
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D014456 | Ulcer NIH | 0.30 |
D003092 | Colitis NIH | 0.30 |
D003093 | Colitis, Ulcerative NIH | 0.30 |
Name (Synonyms) | Correlation | |
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HP:0002583 | Colitis HPO | 0.30 |
HP:0100279 | Ulcerative colitis HPO | 0.30 |
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: 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 52Alphabetical 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