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

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab	Phase II

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Long-Term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis

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:	25
Study Start Date:	June 2003
Estimated Primary Completion Date:	December 2008 (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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235833

Locations


Japan, Metropolis

	Tokyo, Metropolis, Japan

Japan, Prefecture

	Ibaraki, Prefecture, Japan

	Saitama, Prefecture, Japan

	Nagasaki, Prefecture, Japan

	Hiroshima, Prefecture, Japan

	Fukuoka, Prefecture, Japan

	Osaka, Prefecture, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators


Study Director:	Shigeki Hashimoto, Ph.D.	Abbott

More Information

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M02-564
First Received:	October 7, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00235833
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Therapeutic Uses

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Abbott Abbott Japan Co.,Ltd Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00235833