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
- Ulcerative colitisMedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-001682-16-DK
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 840
1)Subject is between the ages of 18 to 75 years
2) Diagnosis of UC for at least 90 days, confirmed by endoscopy (colonoscopy or flexible sigmoidoscopy) 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 683
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 157
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
- Secondary Outcome Measures
Name Time Method