Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study has been completed.

First Received: October 7, 2005 Last Updated: March 9, 2009 History of Changes

Sponsor:	Abbott
Collaborators:	Abbott Japan Co.,Ltd Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00235872

Purpose

The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis

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:

A comparison of adverse events [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ACR 20/50/70 [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
Patient Reported outcomes [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
Physician Global Assessment [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	309
Study Start Date:	August 2004
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab 40 mg eow: Experimental	Biological: adalimumab 40 mg eow, sc

Eligibility

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

Criteria

Inclusion Criteria:

Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.

Exclusion Criteria:

A subject who experienced any of the following during prior study:
- Advanced or poorly controlled diabetes
- Joint surgery (joint evaluated in this study)
A subject who has been prescribed excluded medications during prior study.
History of following during prior study:
- Clinically significant drug or alcohol abuse
- Intravenous (iv) drug abuse
- Active infection with listeria or tuberculosis (TB)
- Lymphoma, leukemia
- And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235872

Locations

Japan, Metropolis

Tokyo, Metropolis, Japan
Japan, Prefecture

Hokkaido, Prefecture, Japan

Miyagi, Prefecture, Japan

Ibaraki, Prefecture, Japan

Gunma, Prefecture, Japan

Saitama, Prefecture, Japan

Chiba, Prefecture, Japan

Kanagawa, Prefecture, Japan

Niigata, Prefecture, Japan

Toyama, Prefecture, Japan

Ishikawa, Prefecture, Japan

Fukui, Prefecture, Japan

Tochigi, Prefecture, Japan

Shizuoka, Prefecture, Japan

Aichi, Prefecture, Japan

Kyoto, Prefecture, Japan

Osaka, Prefecture, Japan

Hyogo, Prefecture, Japan

Okayama, Prefecture, Japan

Tokushima, Prefecture, Japan

Ehime, Prefecture, Japan

Fukuoka, Prefecture, Japan

Nagasaki, Prefecture, Japan

Kagoshima, Prefecture, Japan

Nagano, Prefecture, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators

Study Director:

Shigeki Hashimoto, Ph.D.

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M03-651
Study First Received:	October 7, 2005
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00235872 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Rheumatoid arthritis

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 November 09, 2009