NCT00105300CompletedPhase 3
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
Abbott56 sites in 3 countries300 target enrollmentStarted: October 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 56
- Primary Endpoint
- Induction of clinical remission (CDAI score < 150 at Week 4)
Study Overview
Brief Summary
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- •Normal lab parameters
- •Are willing to give informed consent
- •Have previously used and either were intolerant to or lost response to infliximab
Exclusion Criteria
- •History of certain types of cancer
- •Diagnosis of ulcerative colitis
- •Pregnant female or breast feeding subjects
- •Known obstructive strictures
- •Surgical bowel resection in the past 6 months
- •History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
- •History of poorly controlled medical conditions
- •Specific doses and durations of Crohn's medications
- •Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
Outcomes
Primary Outcomes
Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary Outcomes
- Clinical response measured as
- Decrease in Baseline CDAI score >= 70 points at Week 4
- Decrease in Baseline CDAI score >= 100 points at Week 4
- Changes in IBDQ scores at Week 4
Investigators
Study Sites (56)
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