At a glance
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A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
In Brief
A Phase 2 clinical trial evaluating Rituximab, Placebo, and 5 other interventions for Systemic Sclerosis-Associated PAH. Completed, enrolled 57 participants across 17 sites.
Detailed Summary
Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious, life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the connective tissue characterized by scarring (fibrosis) and atrophy of the skin, joints and tendons, skeletal muscles, and internal organs, and immunological disturbances. One-year survival for patients with SSc-PAH ranges from 50-81%. There is currently no cure for SSc-PAH and treatment is limited to vasodilator therapy used in all forms of PAH. In recent studies, immunotherapy was shown to be effective in treating SSc-interstitial lung disease, another serious, life-threatening manifestation of SSc. In addition, there are compelling pre-clinical data and anecdotal clinical reports that suggest modulation of the immune system may be an effective strategy for treating SSc-PAH. To test this approach, this trial will determine if rituximab, an immunotherapy, has a marked beneficial effect on clinical disease progression, with minimal toxicity, in patients with SSc-PAH when compared to placebo.
Study Details
Timeline
Interventions
Participants receive rituximab intravenous (IV) infusions, 1000 mg each, 14 days apart (Day 0 and Week 2). Rituximab is supplied as a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials, which must be diluted before administration Standard rituximab pre-medications will be provided in preparation for the rituximab infusions.
Participants receive placebo intravenous (IV) infusions 14 days apart (Day 0 and Week 2). Standard pre-medications will be provided in preparation for the infusions.
Up to 20 participants from each treatment arm will be assessed by CMRI at Baseline and at Week 24.
Prednisone dose of 40 mg (or equivalent) by mouth administered the night before and the morning of each study drug infusion.
Methylprednisolone (or equivalent corticosteroid) administered intravenously 30 minutes prior to each study drug infusion.
Diphenhydramine 50 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion. Dose may be repeated every four hours, as needed.
Acetaminophen 650 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion. Dose may be repeated every four hours, as needed.