A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Biological: adalimumab; Biological: placebo

• Registration Number: NCT00445939
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-09
• Primary Completion: 2007-12
• Results First Submitted: 2008-12-23
• Results First Submitted QC: 2009-03-20
• Results First Posted: 2009-03-23
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab 160 mg/80 mg	adalimumab	-
Adalimumab 80 mg/40 mg	adalimumab	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4	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 Outcome Measures

Name	Time	Method
Clinical Remission (CDAI < 150) at Week 2	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	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	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	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