Trials / Completed
CompletedNCT02065622
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 952 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adalimumab | |
| OTHER | Placebo |
Timeline
- Start date
- 2014-03-27
- Primary completion
- 2019-09-05
- Completion
- 2019-11-11
- First posted
- 2014-02-19
- Last updated
- 2020-11-23
- Results posted
- 2020-10-08
Locations
173 sites across 20 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Slovakia, Spain, Switzerland, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02065622. Inclusion in this directory is not an endorsement.