Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
Part of paid clinical trials in Huntsville, Alabama.
- Sponsor
- Abbott
- Study ID
- NCT00195715
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adalimumab — BIOLOGICALAdalimumab 40 mg by subcutaneous injection every other week or every week
Study Details
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.
Key Dates
- Start date
- Sep 30, 2004
- Status verified
- Jul 2011
- Primary completion
- Mar 31, 2006
- Completion
- Dec 31, 2008
Study Design
- Enrollment
- 777 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 156 ]
Locations (63)
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