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|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445939
|Study Director:||Morio Ozawa||Abbott Japan Co.,Ltd|