A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

March 27, 2008 updated by: Abbott
The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

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
      • Fukui, Japan
      • Fukuoka, Japan
      • Gunma, Japan
      • Hokkaido, Japan
      • Hyogo, Japan
      • Ibaraki, Japan
      • Ishikawa, Japan
      • Kagoshima, Japan
      • Kanagawa, Japan
      • Kyoto, Japan
      • Miyagi, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Niigata, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Shizuoka, Japan
      • Tochigi, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Toyama, 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
  • Subjects must have failed prior treatment with one or more DMARDs.
  • A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
  • Body weight less than or equal to 100 kg

Exclusion Criteria:

  • A history of, or current, acute inflammatory joint disease of different origin from RA.
  • Prior treatment with any TNF antagonist, including adalimumab.
  • Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
  • Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

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
Experimental: 20 mg
20 mg adalimumab eow
Biological: adalimumab
20 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
40 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Experimental: 40 mg
40 mg adalimumab eow
Biological: adalimumab
20 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
40 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Experimental: 80 mg
80 mg adalimumab eow
Biological: adalimumab
20 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
40 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: Placebo
Placebo eow
Biological: placebo
placebo sc eow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR20
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR20
Time Frame: Week12
Week12
ACR50
Time Frame: Weeks 12 and 24
Weeks 12 and 24
ACR70
Time Frame: Weeks 12 and 24
Weeks 12 and 24

Collaborators and Investigators

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

Sponsor

Abbott

Collaborators

Eisai Limited

Investigators

  • Study Director: Shigeki Hashimoto, Ph.D., Abbott

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, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2008

Last Update Submitted That Met QC Criteria

March 27, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-575

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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