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

Sponsors and Collaborators:	Abbott Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00647491

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

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

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

No publications provided

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 06, 2009