Study of Rituxan in PAH

Objective

To compare patients with systemic sclerosis-associated pulmonary arterial hypertension treated with rituximab to those on placebo in pulmonary vascular resistance (PVR) as assessed by right heart catheterization.  Two doses of rituximab (1000mg) or placebo are given as IV infusions 2 weeks apart.  Patient is then followed monthly for one year.

IRB Protocol Number

09-0945

All Other Trials

• Lungs & Respiratory

Eligibility and Other Participant Information

Main inclusion criteria:

1) Age 18-70

2) Clinical diagnosis of systemic sclerosis, either limited or diffuse

3) Diagnosis of SSc-PAH (sytemic sclerosis assoiated pulmonary arterial hypertension) within the past 3 years, with a mPAP >/= 30mm Hg

4) Mean PVR > 3 Wood units

5) NYHA Class II, III, or IV

Main exclusion criteria:

1) Treatment with biologic or chemical immunosuppressive agents within 3 months

2) Interstitial lung disease as characterized by diffuse pulmonary infiltrates on CXR (chest x-ray) and a TLC of <70% predicted

For more information, please contact the Pulmonary Hypertension Center at 720-848-6518.