A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
- Conditions
- lcerative colitisMedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-001682-16-HU
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 952
1)Subject is between the ages of 18 to 75 years
2) Diagnosis of UC for at least 90 days, confirmed by endoscopy with biopsy during the Screening Period
3) 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? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 472
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53
1. Subject with Crohn's disease (CD) or indeterminate colitis (IC).
2. Current diagnosis of fulminant colitis and/or toxic megacolon.
3. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
4. 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: The primary objective is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC).;Secondary Objective: not applicable;Primary end point(s): Proportion of subjects achieving clinical remission (per Full Mayo Score) at Week 8;Timepoint(s) of evaluation of this end point: Week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) at Week 8.<br>2. Proportion of Week 8 responders (per Full Mayo Score) achieving clinical remission (per Full Mayo Score) at Week 52.<br>3. Proportion of Week 8 responders (per Full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) at Week 52.;Timepoint(s) of evaluation of this end point: Week 8 and week 52<br>