Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

June 24, 2011

Primary Completion Date

June 5, 2018

Study Completion Date

December 15, 2019

Conditions
Systemic Sclerosis-Associated PAH
Interventions
BIOLOGICAL

Rituximab

"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."

OTHER

Placebo

"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."

DIAGNOSTIC_TEST

CMRI

Up to 20 participants from each treatment arm will be assessed by CMRI at Baseline and at Week 24.

DRUG

prednisone

Prednisone dose of 40 mg (or equivalent) by mouth administered the night before and the morning of each study drug infusion.

DRUG

methylprednisolone

Methylprednisolone (or equivalent corticosteroid) administered intravenously 30 minutes prior to each study drug infusion.

DRUG

diphenhydramine

"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."

DRUG

acetaminophen

"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."

Trial Locations (17)

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medical College, New York

14642

University of Rochester Medical Center, Rochester

15261

University of Pittsburgh Medical Center, Pittsburgh

21205

Johns Hopkins University, Pulmonary and Critical Care Medicine, Baltimore

27514

University of North Carolina at Chapel Hill: UNC Hospitals, Chapel Hill

29425

Medical University of South Carolina, Charleston

43210

Ohio State University, Columbus

48109

University of Michigan, Ann Arbor

52242

University of Iowa, Iowa City

55455

University of Minnesota Health Clinics and Surgery Center, Minneapolis

75390

University of Texas Southwestern Medical Center-William P. Clements University Hospital, Dallas

77030

University of Texas: Memorial Herman Hospital, Houston

80045

University of Colorado Health Sciences Center, Aurora

84132

University of Utah, Salt Lake City

94305

Stanford Health Care, Stanford

02118

Boston University Medical Center, Boston

All Listed Sponsors
collaborator

Autoimmunity Centers of Excellence

OTHER

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01086540 - Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Biotech Hunter | Biotech Hunter