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

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab Biological: placebo	Phase II Phase III

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	352
Study Start Date:	February 2004
Study Completion Date:	August 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
20 mg: Experimental 20 mg adalimumab eow	Biological: adalimumab 20 mg sc eow
40 mg: Experimental 40 mg adalimumab eow	Biological: adalimumab 40 mg sc eow
80 mg: Experimental 80 mg adalimumab eow	Biological: adalimumab 80 mg sc eow
Placebo: Placebo Comparator Placebo eow	Biological: placebo placebo sc eow

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647491

Locations


Japan

	Hokkaido, Japan

	Miyagi, Japan

	Ibaraki, Japan

	Tochigi, Japan

	Gunma, Japan

	Saitama, Japan

	Chiba, Japan

	Tokyo, Japan

	Kanagawa, Japan

	Niigata, Japan

	Toyama, Japan

	Ishikawa, Japan

	Kagoshima, Japan

	Nagano, Japan

	Shizuoka, Japan

	Aichi, Japan

	Kyoto, Japan

	Osaka, Japan

	Hyogo, Japan

	Okayama, Japan

	Tokushima, Japan

	Ehime, Japan

	Fukuoka, Japan

	Nagasaki, Japan

	Fukui, Japan

Sponsors and Collaborators

Abbott

Eisai Limited

Investigators


Study Director:	Shigeki Hashimoto, Ph.D.	Abbott

More Information

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M02-575
First Received:	March 27, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00647491
Health Authority:	Japan: Ministry of Health, Labor and Welfare