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

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