Inclusion Criteria:
- Subject has voluntarily signed and dated an informed consent form, approved by an
Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any
study-specific procedures.
- Subject is 18 years of age or older.
- If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy), or is of childbearing potential and practicing one of
the following methods of birth control:
- condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD).
- contraceptives (oral or parenteral) for three months prior to study drug
administration).
- a vasectomized partner.
- total abstinence from sexual intercourse.
- If female, the results of a serum pregnancy test performed at Screening, prior to the
first dose of Humira (adalimumab) must be negative.
- Subject has confirmed diagnosis of active rheumatoid arthritis as defined by >= 6
swollen joints and >= 9 tender joints.
- Subject has an Erythrocyte Sedimentation Rate (ESR) of > 20 mm/hr. ESR will be
measured using the Westergren method.
- Subject meets the American College of Rheumatology (ACR) criteria for diagnosis of
rheumatoid arthritis (RA) for at least 3 months prior to enrollment and requires to be
started in a biologic containing treatment for the first time, and the investigator
chooses Humira (adalimumab).
- Subject has had unsatisfactory response or intolerance to one or more prior
disease-modifying antirheumatic drugs (DMARDS) (e.g., hydroxychloroquine, leflunomide,
methotrexate, parenteral gold, sulfasalazine, azathioprine or any combination of
those).
- Subject will have an evaluation for latent tuberculosis with a tuberculosis (TB) skin
test done in the screening visit. Subjects who have evidence of prior TB infection
should be given prophylaxis in accordance with Centers for Disease Control and
Prevention (CDC) guidelines.
Exclusion Criteria:
- Subjects who have had prior treatment with cyclophosphamide, chlorambucil or any other
Tumor Necrosis Factor (TNF) biologic as etanercept, infliximab, anakinra, abatacept
and adalimumab.
- Subjects who have been previously treated with total lymphoid irradiation or anti-CD4
or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia (CD4
lymphocytes <= 500/mm3).
- Subject has had prior treatment with intravenous (IV) immunoglobulin or any
investigational agent within 30 days of screening visit.
- Subject has a history of cancer within the past 10 years other than resected basal
cell or squamous cell carcinomas of the skin.
- Subject has a history of malignant lymphoma or leukemia regardless of time since
diagnosis.
- Subject has a history of or current acute inflammatory joint disease of origin other
than RA, e.g., Mixed Connective Tissue Disease (MCTD), Systematic Lupus Erythematosus
(SLE), etc.
- Subject has a history of uncontrolled diabetes mellitis, unstable ischemic heart
disease, active inflammatory bowel disease, active peptic ulcer disease, recent
cerebrovascular accident (CVA) (within 3 months) which, in the opinion of the
investigator, would put the subject at risk by participation in the protocol.
- Subject has a history of active tuberculosis or listeriosis, or other active
infections suggestive of significant or profound immunosuppression, such as
Pneumocystis carinii, aspergillosis or other systemic protozoan or fungal infections.
- Subject has a positive serology for Hepatitis B or Hepatitis C indicating active
infection.
- Subject has a history of positive HIV status defined by an enzyme-linked immunosorbent
assay (ELISA) positive test confirmed by a Western blot test and/or polymerase chain
reaction (PCR).
- Subject has had a persistent or severe infection(s) requiring hospitalization or
treatment with intravenous (IV) antibiotics within 30 days, or oral antibiotics within
14 days, prior to enrollment.
