Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Abbott

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: adalimumab

Drug: methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235859

M02-556

Details and patient eligibility

About

The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints
Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX
Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit
Age 18 years and older

Exclusion criteria

Prior treatment with any TNF antagonist, including adalimumab
History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
Chest X-ray with calcified granuloma and/or pleural scarring
Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours
Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition
Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation
Female who is pregnant or breast-feeding.