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Home / Research – Working for a Cure / Clinical Trials and Observational Studies

Clinical Trials and Observational Studies

The Center is actively participating in clinical trials of new therapies that may improve our patients’ quality of life and better control disease activity.  Current, active clinical trials are listed below.

Current – Active Studies

All Patients with Scleroderma

Johns Hopkins Scleroderma Center Research Registry   
Our Center’s research program is focused on studying human disease in patients in the context of providing outstanding clinical care — investigating disease pathogenesis, risk stratification, screening and treatment approaches, outcome measure development, clinical trials, and impact on quality of life. This registry is a large data, blood sample and tissue repository that is the foundational resource used for all investigations conducted in the Center.  

Johns Hopkins Scleroderma Center Cutaneous Tissue Repository  
This is a skin tissue bank where patients with scleroderma volunteer to donate 3 small punch skin biopsies to be used in various scleroderma research studies. This repository enables studies investigating mechanisms of disease initiation and propagation, including identification of biological pathways that could serve as new treatment targets. Additional this repository supports studies to investigate biomarkers that may predict response to different therapeutic strategies. 

Collaborative, National Quality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER) 
This is a multicenter patient registry for patients with early scleroderma for which we are a participating site. The aim of this study is to collect long-term information about disease course in patients with early disease. 

The Scleroderma Patient-Centered Intervention Network (SPIN) 
This is a multicenter study where participants with scleroderma answer online questionnaires every 3 months in order to determine the most important problems experienced by scleroderma patients.  This information is used to develop self-help modules available to all patients online. Learn more: www.spinsclero.com

Raynaud’s Phenomenon

Optimizing Raynaud Phenomenon Outcome Measures in Systemic Sclerosis (ROSS) 
This study seeks to develop, refine and validate more robust outcome measures for scleroderma-associated Raynaud’s phenomenon, including novel patient reported outcome measures, a smart phone application to quantify Raynaud’s burden, and innovative imaging strategies that assess blood flow before and after provocative testing.  

Cancer Detection Studies

Utility of Intensive Cancer Screening Strategies in High Risk Scleroderma Patients 
This study is testing whether breast MRI and whole body PET/CT scans improve cancer detection in patients who have had scleroderma for less than 3 years and who are positive for an autoantibody associated with increased cancer risk.    

Evaluation of Novel Tumor Markers in Scleroderma and Myositis 
The primary objective of this study is to determine the added value of tumor-associated proteins, circulating tumor cells, and free tumor DNA in detecting subclinical malignancy in patients with new onset scleroderma or myositis, and whether the presence of these tumor markers varies by autoantibody type. 

Myositis and Scleroderma Overlap 

Evaluation of Novel Tumor Markers in Scleroderma and Myositis 
The primary objective of this study is to determine the added value of tumor-associated proteins, circulating tumor cells, and free tumor DNA in detecting subclinical malignancy in patients with new onset scleroderma or myositis, and whether the presence of these tumor markers varies by autoantibody type. 

Noncontrast Muscle Magnetic Resonance Imaging (MRI) in Myopathies and Myositis 
This study examines the effectiveness of MRI as a tool to detect early myopathies in scleroderma patients. 

Interstitial Lung Disease (ILD) 

Early Detection of Clinically Significant Scleroderma-Associated ILD Using At-Home Digital Monitoring Assessments 
In this study, we seek to determine whether at home spirometry assessments at frequent intervals and activity monitors that assess functional status and heart rate can aid in early detection of clinically significant interstitial lung disease that would warrant therapy.  

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 ATHENA-SSc-ILD Study 
This is a multicenter clinical trial evaluating the effectiveness of an investigational drug in patients with diffuse scleroderma and ILD. 

Scleroderma GI Disease

Scleroderma and Gastrointestinal Disease: Insights into Clinical Phenotypes and Disease Pathogenesis 
This investigation is examining the value of a novel imaging test, a whole gut transit study, to define distinct gastrointestinal motility patterns in patients with scleroderma.  

Evaluating the Whole Gut Transit Study as an Outcome Measure for Scleroderma GI Disease 
In this study, results of two separate whole gut transit studies done 1-6 years apart are evaluated in individuals for change to determine the reliability of tests, response to treatment and sensitivity of the test in relationship to changes in actual gastrointestinal symptoms. 

Integrative Analysis of the Gastrointestinal Microbiome in Systemic Sclerosis 
The microbiome of scleroderma patients is compared to household members to identify whether unique features associate with scleroderma. 

Pulmonary Arterial Hypertension (PAH) 

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis or Systemic Sclerosis-Associated Pulmonary Arterial Hypertension 
This study is a clinical trial to determine whether Ifetroban, an investigational drug, softens skin and improves pulmonary arterial hypertension. 

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma (SEPVADIS) 
This study is examining whether individuals with mildly elevated pulmonary pressures have an improvement in distance walked on the 6 minute walk test after 4 months of treatment with Sildenafil. 

Twins & Scleroderma

The Study of Discordant Monozygotic Twins and Identical Multiple Birth Siblings 
This study is recruiting genetically identical siblings, one with scleroderma and at least one without scleroderma, to study biological factors that may associate with the development of scleroderma.  

Novel Therapies for Diffuse Scleroderma

A Phase I Study of reduced intensity conditioning allogeneic bone marrow transplant with post-transplant cyclophosphamide for refractory systemic sclerosis 
Eligible patients with active diffuse scleroderma will undergo bone marrow transplant using bone marrow donated by a close family member who meets compatibility criteria.  

If you are interested in participating in any of our studies, please contact our Research Coordinator:
Gwendolyn Leatherman 
Phone: 410-550-8582 
Email: gleathe1@jh.edu 

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