Trial ID or NCT#

NCT01086540

Status

NOT RECRUITING

Purpose

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.

Official Title

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)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Mark Nicolls
Pulmonologist, Pulmonary critical care specialist
Stanford University Professor in Pulmonary and Critical Care Medicine
Lorinda Chung
Rheumatologist, Immunologist
Professor of Medicine (Immunology and Rheumatology) at the Palo Alto Veterans Affairs Health Care Center
Roham Zamanian
Pulmonary hypertension specialist, Pulmonologist, Critical care specialist
Associate Professor of Medicine (Pulmonary and Critical Care Medicine) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Val Scott
(650) 725-8082