Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Humira (adalimumab)
Intervention description: 40 mg eow
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate quality of life changes in Puerto Rican
      subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF
      Monoclonal Antibody.
    

Eligibility criteria:

        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.