NCT00445939
Completed
Phase 2
A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
ConditionsCrohn's Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- Abbott
- Enrollment
- 90
- Primary Endpoint
- The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450
- •If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
Exclusion Criteria
- •Ulcerative colitis or indeterminate colitis
- •History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
- •Body weight is below 30 kg
- •Surgical bowel resections within the past 6 months
- •Females who are pregnant or breast-feeding or considering becoming pregnant during the study
Outcomes
Primary Outcomes
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
Time Frame: 4 Weeks
CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI \< 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.
Secondary Outcomes
- Clinical Remission (CDAI < 150) at Week 2(Week 2)
- Clinical Response (CR-70 and CR-100) in Period A(Weeks 2 and Week 4)
- Clinical Response (CR-70 and CR-100) in Period B(Week 6 and Week 8)
- Clinical Remission (CDAI <150) at Week 6 and Week 8(Week 6 and Week 8)
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