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

This study has been completed.
Sponsor:
Collaborators:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00445939
First received: March 7, 2007
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Biological: adalimumab
Biological: placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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:
  • Clinical Remission (CDAI < 150) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 90
Study Start Date: February 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab 160 mg/80 mg Biological: adalimumab
160 mg at Week 0, 80 mg at Week 2
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira
Experimental: Adalimumab 80 mg/40 mg Biological: adalimumab
80 mg at Week 0, 40 mg at Week 2
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira
Placebo Comparator: Placebo Biological: placebo
Placebo at Week 0 and Week 2
Other Name: placebo

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445939

Locations
Japan
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
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Investigators
Study Director: Morio Ozawa Abbott Japan Co.,Ltd
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00445939     History of Changes
Other Study ID Numbers: M04-729
Study First Received: March 7, 2007
Results First Received: December 23, 2008
Last Updated: June 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 31, 2014