Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

January 30, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

November 2008 (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 and tolerability parameters

Change History

Complete list of historical versions of study NCT00235833 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

Long-Term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients 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 adult Japanese subjects with rheumatoid arthritis.

Detailed Description

Study Phase

Phase II

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

Completion Date

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participation in the prior adalimumab study
Body weight less than 100 kg.
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.

Exclusion Criteria:

A subject who experienced any of the following during the prior adalimumab sc dosing study:
- Advanced or poorly controlled diabetes
- Any poorly controlled medical condition
- Intra-articular, intramuscular or iv administration of corticosteroids
- Joint surgery.
A subject who has been prescribed excluded medications during previous adalimumab study.
History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.

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

NCT00235833

Responsible Party

Eiichi Makino, Abbott

Study ID Numbers ^ICMJE

M02-564

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

December 2008

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