Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Last updated: August 28, 2007
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00235859
M02-556
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9tender joints

  • Subjects must have received at least one prior DMARD besides MTX, but may have hadefficacy 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 MTXfor at least 4 weeks prior to screening visit

  • Age 18 years and older

Exclusion

Exclusion Criteria:

  • Prior treatment with any TNF antagonist, including adalimumab

  • History of clinically significant drug or alcohol abuse in the previous year, iv drugabuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,andany malignancy with the exception of successfully treated non-metastatic basal-cellcarcinoma of the skin.

  • Subjects may not have been administered a live vaccine within three months prior tostudy drug administration or during the study, treatment with any otherinvestigational agent within 30 days or 5 half-lives of the agent, whichever islonger, prior to the screening evaluation, treatment with any investigational biologicagent, including anti-CD4 antibody, within 6 months prior to the screening evaluation,prior treatment with any TNF antagonist, including Adalimumab, prior exposure toalkylating 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 pepticulcer disease, recent stroke (within 3 months of the screening evaluation) or anypoorly controlled medical condition

  • Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeksprior to screening evaluation

  • Female who is pregnant or breast-feeding.

Study Design

Total Participants: 128
Study Start date:
July 01, 2003
Estimated Completion Date: