Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled,
proof-of-concept pilot study. All participants will first be treated with mycophenolate
mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half
will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early
diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity
measured by an improvement in skin thickening and stability of pulmonary function test
measurements when compared to patients treated with placebo/MMF.