Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

NCT ID: NCT00235833

Last Updated: 2011-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30

Brief Summary

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab 40 mg eow

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

40 mg every other week (eow), subcutaneous (sc)

Interventions

adalimumab

40 mg every other week (eow), subcutaneous (sc)

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira

Eligibility Criteria

Inclusion Criteria

• Participation in the prior adalimumab study
• Body weight less than 100 kg.
• Subject's who wished to continue the study drug administration
• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Japan Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Shigeki Hashimoto, Ph.D.

Role: STUDY_DIRECTOR

Abbott

Locations

Tokyo, Metropolis, Japan

Fukuoka, Prefecture, Japan

Hiroshima, Prefecture, Japan

Ibaraki, Prefecture, Japan

Nagasaki, Prefecture, Japan

Osaka, Prefecture, Japan

Saitama, Prefecture, Japan

Countries

Japan

Other Identifiers

M02-564

Identifier Type: -

Identifier Source: org_study_id