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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445939
• Other study ID #: M04-729
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 7, 2007
• Last updated: June 20, 2011
• Start date: February 2007

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• adalimumab
160 mg at Week 0, 80 mg at Week 2
• adalimumab
80 mg at Week 0, 40 mg at Week 2
• placebo
Placebo at Week 0 and Week 2

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Abbott	Abbott Japan Co.,Ltd, Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4	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.	4 Weeks	No
Secondary	Clinical Remission (CDAI < 150) at 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.	Week 2	No
Secondary	Clinical Response (CR-70 and CR-100) in Period A	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.	Weeks 2 and Week 4	No
Secondary	Clinical Response (CR-70 and CR-100) in Period B	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.	Week 6 and Week 8	No
Secondary	Clinical Remission (CDAI <150) at 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	Week 6 and Week 8	No