A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
Trial ID or NCT#
The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.
- 1. Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
- 2. Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger
- 3. Disease duration of ≤ 36 months (defined as time from the first non−Raynaud phenomenon manifestation)
- 4. For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit
- 5. For disease duration of >18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:
- - Increase ≥ 3 in mRSS units compared with the last visit within previous 1-6 months
- - Involvement of one new body area with ≥ 2 mRSS units compared with the last visit within the previous 1-6 months
- - Involvement of two new body areas with ≥ 1 mRSS units compared with the last visit within the previous 1-6 months
- - Presence of 1 or more Tendon Friction Rub
- 6. Age ≥ 18 years at the screening visit
- 7. If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits
- 8. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for
- - 2 weeks prior to and including the baseline visit.
- 9. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for ≥ 2 weeks prior to and including the baseline visit.
- 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
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Teneisha Podczervinski, MBA
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