Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background

Exclusion Criteria

• •1. Women who are pregnant or breastfeeding. Sexually active fertile men not using effective birth control if their partners are WOCBP (Women of Child Bearing Potential).
• •2. Target Disease Exceptions
• •a) Rheumatic autoimmune disease other than RA; fibromyalgia or keratoconjunctivitis/xerostomia are allowed, as long as these will not confound the CLINICAL EFFICACY OUTCOMES.
• •3. Medical History and Concurrent Diseases
• •1. Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
• •2. Subjects who underwent previous MCP (metacarpophalangeal) arthroplasty, have such a procedure scheduled, or anticipate the need for such a procedure during the study.
• •3. Major surgery (including joint surgery) within 8 weeks prior to screening
• •4. Subjects with active vasculitis of a major organ system, with the exception of rheumatoid nodules or minor rheumatoid vasculitis lesions of the skin
• •5. Subjects with current uncontrolled symptoms of severe, progressive, or uncontrolled renal, hepatic hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, including Cirrhosis with Child-Pugh Class \>=2 or COPD (chronic obstructive pulmonary disease) with FEV1 (forced expiratory volume in 1 second) /FVC (forced vital capacity) \< 0.6
• •6. Female subjects who have had a recent breast cancer screening that is suspicious for malignancy and where the diagnosis is not excluded.
• •h) Subjects who currently abuse drugs or alcohol. i) Subjects with evidence of active or latent bacterial or viral infections at the time of potential enrollment, including HIV.
• •j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed.
• •k) Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication.
• •l) Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection.
• •m) Subjects at risk for tuberculosis (TB) or not treated for latent TB is tested positive.
• •n) Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
• •o) Subjects who have abnormal laboratory values
• •4. Prohibited Treatments and/or Therapies
• •1. Subjects who have at any time received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.
• •2. Any concomitant biologic DMARD, such as anakinra.
• •3. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to CAMPATH, anti-CD4 (cluster of differentiation 4), anti-CD5, anti-CD3, and anti-CD19.
• •4. Anti-CD20 treatment within the last 6 months (OK to include if they were dosed \> 6 months ago).
• •5. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil, within \<= 4 weeks prior to baseline.
• •6. Treatment with etanercept within 2 weeks, infliximab/certolizumab/golimumab/adalimumab with \<=8 weeks, anakinra within \<=1 week prior to baseline.
• •7. Previous abatacept use.
• •8. Treatment with sulfasalazine within \< 4 weeks prior to baseline