Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis

The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).

Inclusion Criteria:

• Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12

• Patients 18 years of age or older

• Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control

• Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab

• Diagnosis of active RA defined by >= 5 swollen joints and one of the following:

  • Positive RF
  • One or more joint erosions present of x-ray
  • HAQ score > 1

Exclusion Criteria:

• Patient has failed 2 or more biologics
• Patient who had previous treatment with cyclophosphamide and chlorambucil
• Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +< 500/mm3)
• History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
• History of malignant lymphoma or leukemia regardless of treatment