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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
adalimumab
adalimumab
placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Adalimumab 160 mg/80 mg

Adalimumab 80 mg/40 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
March 7, 2007
Last Updated
June 20, 2011
Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd, Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00445939
Brief Title
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd, Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab 160 mg/80 mg
Arm Type
Experimental
Arm Title
Adalimumab 80 mg/40 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
160 mg at Week 0, 80 mg at Week 2
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
80 mg at Week 0, 40 mg at Week 2
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Placebo at Week 0 and Week 2
Primary Outcome Measure Information:
Title
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Clinical Remission (CDAI < 150) at Week 2
Description
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.
Time Frame
Week 2
Title
Clinical Response (CR-70 and CR-100) in Period A
Description
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.
Time Frame
Weeks 2 and Week 4
Title
Clinical Response (CR-70 and CR-100) in Period B
Description
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.
Time Frame
Week 6 and Week 8
Title
Clinical Remission (CDAI <150) at Week 6 and Week 8
Description
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
Time Frame
Week 6 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morio Ozawa
Organizational Affiliation
Abbott Japan Co.,Ltd
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Chiba
Country
Japan
City
Ehime
Country
Japan
City
Fukuoka
Country
Japan
City
Hiroshima
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Kagawa
Country
Japan
City
Kanagawa
Country
Japan
City
Kochi
Country
Japan
City
Kyoto
Country
Japan
City
Miyagi
Country
Japan
City
Okayama
Country
Japan
City
Okinawa
Country
Japan
City
Osaka
Country
Japan
City
Shiga
Country
Japan
City
Shizuoka
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22325170
Citation
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.
Results Reference
derived

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

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