A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

Exclusion Criteria

• •1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
• •2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
• •3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
• •4. Infected ulcer prior to randomization
• •5. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
• •6. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA
• •7. Anti-CD20, and cyclophosphamide within 12 months prior to baseline visit.
• •8. Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit
• •9. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
• •10. Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit
• •11. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit
• •12. Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit
• •13. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit
• •14. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers.
• •15. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
• •16. Positive for hepatitis B surface antigen prior to the baseline visit
• •17. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit
• •18. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
• •19. Any of the following at the screening visit: Hemoglobin \<8.5 g/dL; WBC \< 3,000/mm3 (\<3 x 109/L); platelets \< 100,000/mm3 (\<3 x 109/L); serum creatinine \> 2 x ULN; serum ALT or AST \> 2 x ULN
• •20. Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen
• •21. Patients with a history of anaphylaxis to abatacept