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

March 7, 2007
June 20, 2011
February 2007
December 2007   (final data collection date for primary outcome measure)
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.
Crohn's Disease Activity Index (CDAI)
Complete list of historical versions of study NCT00445939 on ClinicalTrials.gov Archive Site
  • 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
Inflammatory Bowel Disease Questionnaire (IBDQ)
Not Provided
Not Provided
 
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Biological: adalimumab
    160 mg at Week 0, 80 mg at Week 2
    Other Names:
    • ABT-D2E7
    • adalimumab
    • Humira
  • Biological: adalimumab
    80 mg at Week 0, 40 mg at Week 2
    Other Names:
    • ABT-D2E7
    • adalimumab
    • Humira
  • Biological: placebo
    Placebo at Week 0 and Week 2
    Other Name: placebo
  • Experimental: Adalimumab 160 mg/80 mg
    Intervention: Biological: adalimumab
  • Experimental: Adalimumab 80 mg/40 mg
    Intervention: Biological: adalimumab
  • Placebo Comparator: Placebo
    Intervention: Biological: placebo
Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Not Provided
December 2007   (final data collection date for primary outcome measure)

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
Both
15 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00445939
M04-729
Not Provided
Eiichi Makino, Abbott
Abbott
  • Abbott Japan Co.,Ltd
  • Eisai Co., Ltd.
Study Director: Morio Ozawa Abbott Japan Co.,Ltd
Abbott
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP