A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
|ClinicalTrials.gov Identifier: NCT00445939|
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : March 23, 2009
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Biological: adalimumab Biological: placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2007|
|Experimental: Adalimumab 160 mg/80 mg||
160 mg at Week 0, 80 mg at Week 2
|Experimental: Adalimumab 80 mg/40 mg||
80 mg at Week 0, 40 mg at Week 2
|Placebo Comparator: Placebo||
Placebo at Week 0 and Week 2
- 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.
- Clinical Remission (CDAI < 150) at Week 2 [ Time Frame: Week 2 ]Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.
- Clinical Response (CR-70 and CR-100) in Period A [ Time Frame: Weeks 2 and Week 4 ]The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4.
- Clinical Response (CR-70 and CR-100) in Period B [ Time Frame: Week 6 and Week 8 ]The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.
- Clinical Remission (CDAI <150) at Week 6 and Week 8 [ Time Frame: Week 6 and Week 8 ]The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445939
|Study Director:||Morio Ozawa||Abbott Japan Co.,Ltd|