A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Diffuse Cutaneous Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT02161406

Run by

Dinesh Khanna, MD, MS

People needed

88

Starts

2014-09-01

Expected to finish

2018-10-17

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
• Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger
• Disease duration of ≤ 36 months (defined as time from the first non-Raynaud phenomenon manifestation)
• For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit
• 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
• Age ≥ 18 years at the screening visit
• If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits
• 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.
• 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.

You may not qualify if…

• Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
• Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
• Major surgery (including joint surgery) within 8 weeks prior to screening visit
• Infected ulcer prior to randomization
• Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
• 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
• Anti-CD20, and cyclophosphamide within 12 months prior to baseline visit.
• Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit
• Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
• Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit
• Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit
• Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit
• Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit
• 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.
• 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).
• Positive for hepatitis B surface antigen prior to the baseline visit
• 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
• 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).
• 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
• Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen
• Patients with a history of anaphylaxis to abatacept

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Center at Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Swedish Health Services — Seattle, Washington, United States
• St. Joseph Health Care London — London, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Royal Free Hospital — London, United Kingdom
• Arthritis Associates of Southern California — Los Angeles, California, United States
• University of California- Los Angeles — Los Angeles, California, United States
• Stanford University — Redwood City, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Northwestern University — Chicago, Illinois, United States
• Harvard Mass General — Boston, Massachusetts, United States
• Boston University — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Rutgers University Clinical Research Center — New Brunswick, New Jersey, United States
• Steffens Scleroderma Center — Albany, New York, United States
• NorthWell Health — Great Neck, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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