Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited
About this trial
This is an interventional treatment trial for Scleroderma, Diffuse focused on measuring Ifetroban, Scleroderma, Systemic Sclerosis
Eligibility Criteria
Inclusion Criteria:
Diffuse Cutaneous Criterion:
1. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first non-Raynaud symptom.
SSc-PAH Criteria:
- Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization
- Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
- New York Heart Association (NYHA) Class I-III Heart Failure
Exclusion Criteria:
- Have a diagnosis of systemic sclerosis sine scleroderma;
- Be less than 18 years of age or greater than or equal to 80 years of age;
- Be pregnant, nursing, or planning to become pregnant;
- Current or planned treatment with prostanoid therapy;
- Current or planned treatment with pirfenidone;
- Use of rituximab in the last 3 months;
- Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months;
- Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
- Significant lung disease, defined as FVC < 50% predicted or DLCO <40% predicted;
- Significant kidney disease, defined as Glomerular Filtration Rate (GFR) < 60 ml/min;
- Have moderate or severe hepatic impairment;
- Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
- Known hypersensitivity to gadolinium;
- Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
- Use of aspirin > 81 mg per day in the last two weeks;
- Use of warfarin, heparin or other anticoagulants in the last 30 days;
- Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
- Have a history of allergy or hypersensitivity to ifetroban;
- Have taken investigational drugs within 30 days before study treatment administration;
- Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments;
- Be otherwise unsuitable for the study, in the opinion of the investigator.
Sites / Locations
- The Universtity of Arizona Arthrtis CenterRecruiting
- UCLARecruiting
- New Life Medical Research Center, Inc.
- Cleveland Clinic - FloridaRecruiting
- Johns Hopkins UniversityRecruiting
- Massachusetts General HospitalRecruiting
- Boston University School of Medicine
- Hospital for Special SurgeryRecruiting
- Thomas Jefferson UniversityRecruiting
- Medical University of South Carolina
- Vanderbilt University Medical Center
- Baylor Research InstituteRecruiting
- Benaraoya Research Institute at Virginia Mason
- KDH - Kokilaben Dhirubhai Ambani HospitalRecruiting
- B. J. Government Medical CollegeRecruiting
- PGIMERRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Patients with dcSSc
Patients with SSc-PAH
Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days