Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Public ClinicalTrials.gov record NCT01086540. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01086540
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
- Rituximab Biological
- Placebo Other
- CMRI Diagnostic Test
- prednisone Drug
- methylprednisolone Drug
- diphenhydramine Drug
- acetaminophen Drug
Biological · Other · Diagnostic Test + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 24, 2011 (Actual)
- Primary completion
- Jun 5, 2018 (Actual)
- Completion
- Dec 15, 2019 (Actual)
- Last update posted
- Feb 21, 2023
2011 – 2019
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Johns Hopkins University, Pulmonary and Critical Care Medicine | Baltimore | Maryland | 21205 | — |
| Boston University Medical Center | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota Health Clinics and Surgery Center | Minneapolis | Minnesota | 55455 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University of North Carolina at Chapel Hill: UNC Hospitals | Chapel Hill | North Carolina | 27514 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Texas Southwestern Medical Center-William P. Clements University Hospital | Dallas | Texas | 75390 | — |
| University of Texas: Memorial Herman Hospital | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01086540, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 21, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01086540 live on ClinicalTrials.gov.