A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 27, 2008

Last Updated Date

March 27, 2008

Start Date ^ICMJE

February 2004

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ACR20 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

ACR20 [ Time Frame: Week12 ] [ Designated as safety issue: No ]
ACR50 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
ACR70 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Biological: adalimumab
Biological: placebo

Study Arms / Comparison Groups

Experimental: 20 mg adalimumab eow
Experimental: 40 mg adalimumab eow
Experimental: 80 mg adalimumab eow
Placebo Comparator: Placebo eow

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

352

Completion Date

August 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00647491

Responsible Party

Eiichi Makino, Abbott

Study ID Numbers ^ICMJE

M02-575

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Eisai Limited

Investigators ^ICMJE

Study Director:

Shigeki Hashimoto, Ph.D.

Abbott

Information Provided By

Abbott

Verification Date

March 2008

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