Scleroderma Center

Ongoing Research and Clinical Trials

Clinical Drug Trials and Observational Studies

Our Scleroderma Center is committed to participating in  clinical trials.  We feel it is a vital step in working together to find treatments for scleroderma.   Without clinical trials, our field will not advance. If you are interested in participating in a trial or would like additional information regarding clinical studies at our Center, please contact Maureen Laffoon at

Currently Enrolling Patients:

Skin Biopsy Research Repository

Enrolling:  Scleroderma Patients and Healthy Controls
The UPMC/University of Pittsburgh Scleroderma Center established a systemic sclerosis (SSc) skin biopsy research repository in which tissue specimens are stored and used for SSc research.  We are enrolling subjects who were diagnosed with SSc and healthy controls. A “control” is a person who does not have a specified disease and could be compared to a person who does have that disease.   To be eligible to participate in this research as a control, you must be 18 years of age or older.  The researchers are also maintaining a parallel SSc database of computerized medical information.

The cause of SSc is not fully understood although hereditary factors, environmental exposures and immune system dysfunction may each play a role.  The SSc skin biopsy research repository and database will allow continued research into the complications, causes and treatment of SSc.  All biopsies and will be processed and stored in Dr. Lafyatis’ research laboratory.   The skin biopsy procedure should take approximately 30 minutes to perform.

The skin cells will be analyzed for potential causes of SSc.  Studies may involve comparing test results of skin from persons with and without SSc. While the nature of future research studies using skin samples is not yet fully known, they may involve identifying inherited factors called genes that can: 1) increase the risk of developing SSc, 2) modify the severity of the disease, or 3) control components of the immune system (immunogenetic studies).   If studies would require that your skin be sent to an outside research center for testing, it would be sent without identifying information.

Evaluation  of   Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A   Phase I/II Multicenter, Rando-mized, Double-Blinded Safety Study (BRAVOS):

Brentuximab vedotin (name brand Adcetris) is a drug that was developed and has FDA approval for the treatment of lymphoma.  This research is being done to evaluate the safety and tolerability of brentuximab in the treatment of diffuse skin disease in scleroderma.   Patients must be early in their disease with worsening skin to participate.  Two of three patients will receive brentuximab vedotin, and the other individual, placebo.   The study lasts 48 weeks and involves 14 visits. Patients will be able to remain on their current scleroderma medications.

Optimizing Raynaud Phenomenon Outcome Measures in Systemic Sclerosis (ROSS):

The purpose of this research study is to improve clinical trial design when studying Raynaud phenomenon (RP) in systemic sclerosis (SSc). We are validating a new patient reported questionnaire, testing a smart phone application to assess Raynaud attack frequency/duration and comparing new imaging techniques for skin blood flow in the hands. The study is over one year, as we recognize Raynaud symptoms change across seasons, and wish to gain a better understanding of how seasons affects these new outcome measures. Ultimately, improving outcome measures could aid in having a drug show a positive change and gain approval for Raynaud treatment. The observational study will last 48 weeks, although those who start a new medication for Raynaud medication will be asked to be follow for a longer period so the effect of the new medication can be captured. There are six study visits within those 48 weeks. At each visit, all subjects will be asked to complete a one week diary the number of Raynaud attack, and on the day of the visit complete a small packet of self-administered questionnaires that collect information on your Raynaud symptoms, function, mood, and quality of life. At all visits except week 36, subjects will undergo noninvasive blood flow imaging using a laser speckle contrast imaging (LSCI) and infrared thermography (IT) machine imaging of their hand. Visits will be 90 minutes on the first day, and thereafter 30-60 minutes.

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients with Systemic Sclerosis-Associated Pulmonary Arterial Hypertension.

The purpose of this study is to find out if ifetroban is effective and helps reduce symptoms associated with systemic sclerosis. Approximately 34 adults will take part in this study. Half of the participants in this study will receive ifetroban and half will receive placebo. During the study, treatment will be unknown to participants, their doctors, the research team and the sponsor of the study.

Participants who volunteer to take part in this research study will have 5 visits 3 months apart. Treatment will be taken for up to 1 year followed by a follow-up phone call. The treatment medicine and medical care related to the study will be provided at no cost to you. Stipends for your time and travel are provided to eligible participants.

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

The purpose of this study is to help understand how safe and effective PRA023, the study drug, is in treating Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) when compared to placebo over the course of 50 weeks. PRA023 is a monoclonal antibody that has the potential to be both an anti-inflammatory and an anti-fibrotic agent.

Patients will receive PRA023 or placebo Intravenously (IV) on Week 0, Week 2, and then every 4 weeks thereafter until Week 50. After completion of 50 weeks of treatment, you have the option to continue in the open-label extension phase of the study where you will receive PRA023 IV every 4 weeks.

Contact Us

Academic Offices:
Division of Rheumatology and Clinical Immunology
S700 Biomedical Science Tower
3500 Terrace Street
Pittsburgh, PA 15261


Phone: (412) 648-7871

Contact Us

Division of Rheumatology and Clinical Immunology Offices

S700 Biomedical Science Tower
3500 Terrace Street
Pittsburgh, PA 15261
412-383-8000  |  Email Us

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