A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: adalimumab (Biological); adalimumab (Biological); placebo (Biological)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Morio Ozawa, Study Director, Affiliation: Abbott Japan Co.,Ltd
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
Secondary outcome: Clinical Remission (CDAI < 150) at Week 2Clinical Response (CR-70 and CR-100) in Period A Clinical Response (CR-70 and CR-100) in Period B Clinical Remission (CDAI <150) at Week 6 and Week 8
Eligibility
Minimum age: 15 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Aichi, Japan
Chiba, Japan
Ehime, Japan
Fukuoka, Japan
Hiroshima, Japan
Hokkaido, Japan
Hyogo, Japan
Kagawa, Japan
Kanagawa, Japan
Kochi, Japan
Kyoto, Japan
Miyagi, Japan
Okayama, Japan
Okinawa, Japan
Osaka, Japan
Shiga, Japan
Shizuoka, Japan
Tokyo, Japan
Additional Information
Starting date: February 2007
Last updated: June 20, 2011
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