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

June 20, 2011 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: placebo
Placebo at Week 0 and Week 2
Experimental: Adalimumab 160 mg/80 mg
Biological: adalimumab
160 mg at Week 0, 80 mg at Week 2
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg at Week 0, 40 mg at Week 2
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Adalimumab 80 mg/40 mg
Biological: adalimumab
160 mg at Week 0, 80 mg at Week 2
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg at Week 0, 40 mg at Week 2
Other Names:
  • ABT-D2E7
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
Time Frame: 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.
4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Remission (CDAI < 150) at Week 2
Time Frame: 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
Clinical Response (CR-70 and CR-100) in Period A
Time Frame: 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.
Weeks 2 and Week 4
Clinical Response (CR-70 and CR-100) in Period B
Time Frame: 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.
Week 6 and Week 8
Clinical Remission (CDAI <150) at Week 6 and Week 8
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Eisai Co., Ltd.
Abbott Japan Co.,Ltd

Investigators

  • Study Director: Morio Ozawa, Abbott Japan Co.,Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-729

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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