Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
NCT02065622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 952
Last updated 2020-11-23
Summary
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
Conditions
- Ulcerative Colitis (UC)
Interventions
- DRUG
- OTHER
-
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AbbVie Inc. · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-27
- Primary Completion
- 2019-09-05
- Completion
- 2019-11-11
- FDA Drug
- Yes
Countries
- United States
- Austria
- Belgium
- Canada
- Czechia
- Denmark
- France
- Germany
- Hungary
- Israel
- Italy
- Japan
- Netherlands
- Poland
- Romania
- Slovakia
- Spain
- Switzerland
- Ukraine
- United Kingdom
Study Locations
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