Crohn’s Disease or Ulcerative Colitis
Conditions
Brief summary
Percentage of participants with ≥1 adverse event (AE), Percentage of participants discontinuing from study therapy due to AE
Detailed description
Percentage of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 364, Percentage of participants achieving 2-patient-reported outcomes (PRO-2) remission per Crohn’s Disease Activity Index score at Week 364, Percentage of participants achieving endoscopic remission per Simplified Endoscopic Score for Crohn’s Disease at Week 364, Percentage of participants with UC achieving clinical remission per Modified Mayo Score at Week 364
Interventions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with ≥1 adverse event (AE), Percentage of participants discontinuing from study therapy due to AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 364, Percentage of participants achieving 2-patient-reported outcomes (PRO-2) remission per Crohn’s Disease Activity Index score at Week 364, Percentage of participants achieving endoscopic remission per Simplified Endoscopic Score for Crohn’s Disease at Week 364, Percentage of participants with UC achieving clinical remission per Modified Mayo Score at Week 364 | — |
Countries
Czechia, France, Hungary, Poland
Outcome results
None listed