Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Phase 3
Completed
- Conditions
- lcerateive Colotis
- Registration Number
- JPRN-jRCT2080222598
- Lead Sponsor
- AbbVie GK
- Brief Summary
Safety and efficacy of adalimumab in pediatric patients were evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 101
Inclusion Criteria
Diagnosis of Ulcerative Colitis (UC) for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.
Exclusion Criteria
Subject with Crohn's disease (CD) or indeterminate colitis (IC).
Current diagnosis of fulminant colitis and/or toxic megacolon.
Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
Chronic recurring infections or active Tuberculosis (TB).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>Percentage of participants who achieve clinical remission per partial Mayo score (PMS) [ Time Frame: Week 8 ]<br>Percentage of participants who responded at Week 8 per PMS and achieve clinical remission per Mayo score [ Time Frame: Week 52 ]
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>Percentage of participants who achieve mucosal healing [ Time Frame: Week 52 ]<br>Percentage of participants in Mayo clinical response in Week 8 responders [ Time Frame: Week 52 ]<br>Percentage of participants who achieve Mayo clinical remission in Week 8 remitters [ Time Frame: Week 52 ]<br>Percentage of participants receiving corticosteroid at Baseline who have discontinued corticosteroid prior to Week 52 and are in Mayo clinical remission in Week 8 responders [ Time Frame: Week 52 ]<br>Partial Mayo Score, Mayo endoscopy subscore