A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.
- Conditions
- lcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-003032-77-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 85
? Subjects from the ages of 4 to 17 prior to baseline dosing.
? Diagnosis of 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 85
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
? 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 TB
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).;Secondary Objective: not applicable;Primary end point(s): ? The proportion of subjects who achieve clinical remission at Week 8 as measured by PMS<br>? The proportion of subjects who responded at Week 8 per PMS and achieve clinical remission at Week 52 as measured by Mayo score;Timepoint(s) of evaluation of this end point: Week 8, Week 52<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? Proportion of subjects who achieve mucosal healing at Week 52 as measured by Mayo endoscopy subscore (defined as = 1) in Week 8 responders per PMS <br>? Proportion of subjects in PUCAI remission (defined as < 10) in Week 8 responders per PMS at Week 52 ;Timepoint(s) of evaluation of this end point: Week 52<br>