Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

March 9, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety parameters

Change History

Complete list of historical versions of study NCT00235872 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

ACR 20/50/70
Patient Reported outcomes
Physician Global Assessment

Descriptive Information

Brief Title ^ICMJE

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Official Title ^ICMJE

Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Biological: adalimumab

Study Arms / Comparison Groups

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

309

Completion Date

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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

NCT00235872

Responsible Party

Eiichi Makino, Abbott

Study ID Numbers ^ICMJE

M03-651

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Abbott Japan Co.,Ltd
Eisai Limited

Investigators ^ICMJE

Study Director:

Shigeki Hashimoto, Ph.D.

Abbott

Information Provided By

Abbott

Verification Date

February 2009

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