Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Exclusion Criteria

• •1. Presence of involvement that does not meet the criteria for non-severe disease
• •2. Treatment with CYC within 3 months prior to screening
• •3. Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment
• •4. Treatment with prednisone or prednisolone\> 30 mg/day for \> 28 days immediately prior to study entry
• •5. Initiation or dose increase of the maintenance immunosuppressive agent (MTX, AZA, MA) within 3 months prior to screening
• •6. Evidence of active infection (includes chronic infection)
• •7. Patients who are pregnant or who are nursing
• •8. Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen
• •9. Inability to comply with study guidelines
• •10. Cytopenia: platelet count \< 100,000/mm3, white blood cell count (WBC) \< 3,000/mm3 (3 x 109/L), absolute neutrophil count \< 1500/mm3, hemoglobin (Hgb) \< 8.5 g/dL
• •11. Chronic renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min
• •12. AST or ALT \> 3 times above the upper limit of the normal laboratory range
• •13. Known current use of illegal drugs
• •14. Other uncontrolled disease (co-morbidity) that could prevent a patient from fulfilling the study requirements or that would substantially increase the risk of study procedures
• •15. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
• •16. Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer)
• •17. A live vaccination fewer than 3 months before enrollment
• •18. Current clinical, radiographic, or laboratory evidence of active tuberculosis
• •19. A history of active tuberculosis within the past 3 years even if treated
• •20. A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
• •21. Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
• •22. Latent tuberculosis currently being treated with isoniazid (INH) or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control (CDC)) who have received such therapy for 4 weeks or less prior to randomization (Day 1). Subjects with a positive tuberculosis screening test indicative of latent tuberculosis will be eligible for the study if they have no evidence of current tuberculosis on chest xray at screening and they are actively being treated for tuberculosis with INH or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., CDC) that has been given for at least 4 weeks prior to randomization (Day 1). These subjects must complete treatment according to local health authority guidelines.
• •23. History of herpes zoster that resolved less than 2 months prior to enrollment
• •24. Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months
• •25. Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months
• •26. Treatment with intravenous immunoglobulin given at an immunomodulatory dosage or plasma exchange within the past 3 months. Patients can be enrolled if they are otherwise eligible and receiving immunoglobulin replacement for hypogammaglobulinemia.
• •27. Treatment with infliximab, etanercept, adalimumab, tocilizumab, or any other biologic agent within the past 3 months or 5 half lives of the agent (whichever is longer)