Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

This study has been completed.
Eisai Limited
Information provided by:
Abbott Identifier:
First received: October 7, 2005
Last updated: August 28, 2007
Last verified: August 2007
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: adalimumab
Drug: methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • ACR20

Secondary Outcome Measures:
  • Safety parameters

Enrollment: 128
Study Start Date: July 2003

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00235859

Sponsors and Collaborators
Eisai Limited
Study Director: Beverly Paperiello Abbott
  More Information

No publications provided Identifier: NCT00235859     History of Changes
Other Study ID Numbers: M02-556
Study First Received: October 7, 2005
Last Updated: August 28, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Abbott:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 27, 2015