| Scleroderma Clinical Trials (MAIN MENU) | |
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| Scleroderma Clinical Trials: Current Studies, Open Enrollments |
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| Overview of Scleroderma Clinical Trials and Treatments |
| Systemic Scleroderma Symptoms. At present, there are no proven treatments or cure for any forms of scleroderma. However, there are effective therapies for many of the symptoms as well as clinical trials for specific scleroderma related symptoms. ISN. (Also see: What is Scleroderma and Types of Scleroderma) |
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| Treatment of complications associated with systemic sclerosis. Systemic sclerosis is characterized by various circulatory, dermatological, gastrointestinal, musculoskeletal, pulmonary, and renal complications. Although there is no cure for systemic sclerosis, management of its associated complications can help improve patients' quality of life. (PubMed) Am J Health Syst Pharm. 2008 Feb 15; 65(4):315-21. |
The following clinical trials are currently recruiting. |
| AIMSPRO for Systemic Sclerosis |
| AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis. To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score. Centre for Rheumatology and Connective Tissue Diseases, Royal Free Hospital NHS Trust, Hampstead. ClinicalTrials.gov. |
| Daval International receives award for its anti-inflammatory agent AIMSPRO. AIMSPRO is a new generation biological medicine which is sourced and manufactured in Australia. It is derived from hyperimmune caprine serum and is currently under Phase II trialing in Europe for Scleroderma and for bladder dysfunction in Secondary Progressive Multiple Sclerosis. Both trials are expected to report in the first half of 2010. Medical News. 11/09/09. |
| Sypharma - Aimspro. Australia’s Sypharma, a privately owned company will be supplying an aseptically manufactured biological (AIMSPRO) for clinical trials in Europe. AIMSPRO is an injectable hyperimmune caprine serum derivative. Two clinical trials with AIMSPRO address late stage Scleroderma (Diffuse Sclerosis) and Bladder Dysfunction in Secondary Progressive Multiple Sclerosis. Sypharma. 2010. |
| Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis |
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| Ambrisentan for Scleroderma |
| Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis. The hypothesis on which we are basing this study is that an endothelin receptor antagonist and disease modifying agent with antifibrotic properties will have additive influence on fibrosis, inhibit cellular and humoral hyperactivity and interfere with smooth muscle proliferation in the vessel wall. The combination of these two agents will also be the first regimen to address the heterogeneity of scleroderma manifestations including ILD, pulmonary arterial hypertension and skin manifestations. This study is currently recruiting participants. ClinicalTrials.gov. Identifier: NCT01093885. |
| A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma). A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis. This study is currently recruiting participants. ClinicalTrials.gov. |
| Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan. The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma. Currently Recruiting. clinicaltrials.gov. |
| Atherosclerosis in Scleroderma |
| Premature Coronary Atherosclerosis in Scleroderma. The purpose of this trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls. This study is currently recruiting participants. clinicaltrials.gov, May, 2009. (Also see: Atherosclerosis) |
| ASTIS Study |
| ASTIS Study: High Dose Immunoablation and Hematopoietic Stem cell Transplantation versus Monthly Intravenous Pulse Therapy Cyclophosphomide in Severe Systemic Sclerosis. ISN. |
| Bosentan, Tracleer |
| Bosentan (Tracleer) appears to be beneficial for a variety of scleroderma symptoms, such as digital ulcers, pulmonary fibrosis, pulmonary hypertension, and skin fibrosis. ISN. |
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| Combination Therapies |
| Severe Systemic Sclerosis - Combination Therapy Study (05-070T). A Randomized, Open-Label, Phase II/III Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis. Presently Recruiting. Feinstein Institute for Medical Research. |
| Cyclophosphamide (Cytoxan ®) and Revimmune |
| Current Studies, Initial Results Positive |
| Cyclophosphamide (Cytoxan) and Revimmune for Scleroderma Lung Disease. Clinical trial and research information on cyclophosphamide for pulmonary alveolitis. ISN. |
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| Cyclophosphamide and rATG with Hematopoietic Stem Cell Support |
| Cyclophosphamide and rATG With Hematopoietic Stem Cell Support Clinical Trial. To evaluate the efficacy (phase II) of two treatment modalities: pulse cyclophosphamide versus high dose cyclophosphamide and rATG (rabbit antithymocyte globulins) rescued with autologous peripheral blood stem cell transplant (PBSCT). Currently recruiting. Northwestern University. ClinicalTrials.gov. Contact information: d-spahovic@northwestern.edu and tel 1-312-908-0059. |
| Journal Publications by Richard K. Burt, M.D. Division of Immunotherapy. Northwestern University, Chicago, Illinois. |
| DETECT (Screening for PH) |
| Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc) (DETECT). A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension. This study is currently recruiting participants. Verified by Actelion, October 2008. ClinicalTrials.gov. (Also see: Pulmonary Hypertension) |
| Dasatinib |
| Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis. The purpose of this study is to see if dasatinib, with its known side effects, is safe to use in patients with scleroderma pulmonary fibrosis. This study is currently recruiting participants. Clinicaltrials.gov. August 2009. (Also see: Pulmonary Fibrosis) |
| DISTOL-1 |
| Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine (DISTOL-1). This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Principal Investigator: James Seibold, MD. Started May 2009. ClinicalTrials.gov. (Also see: Digital Ulcers) |
| Fludarabine and Donor Peripheral SCT |
| Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis. This phase II trial is studying how well giving fludarabine together with total-body irradiation followed by a donor peripheral stem cell transplant works in treating patients with severe systemic sclerosis. Clinical Trials.gov 04/02/09. |
| Imatinib Mesylate (Gleevec) |
| Current Studies, Initial Results Positive, 2008 |
| Imatinib Mesylate (Gleevec) Clinical Trials for Systemic Scleroderma. Imatinib mesylate (Gleevec) is currently used for certain forms of leukemia, and is now in the following clinical trials for safety and efficacy for systemic scleroderma. This study is ongoing, but not recruiting participants. ISN. |
| Nilotnib (Tasigna) |
| Nilotinib (Tasigna) in the Treatment of Systemic Sclerosis. This Phase II Open Label study is currently recruiting participants. The purpose of this study is to learn how safe and tolerable a medication called Nilotinib (Tasigna) will be for patients diagnosed with Systemic Sclerosis. The secondary goal is to assess how effective Nilotinib is in treating patients with scleroderma. ClinicalTrials.gov. (Also see: Scleroderma Clinical Trials: Current Studies) |
| Pulmonary Fibrosis with Systemic Sclerosis |
| Open Enrollment, 2008 |
| Recruiting is taking place for a multi-center placebo controlled research study for pulmonary fibrosis with systemic sclerosis sponsored by Novartis Pharmaceuticals. Male and female patients, 18 to 65 years of age may be eligible for participation. |
| Interested patients can contact the Medical College of Wisconsin (414-456-7019), University of Houston (713-500-7118), UCLA (310-825-4744), Boston University (617-638-4344) or at John Hopkins University (410-550-8582) in Baltimore, Maryland. Novartis Pharmaceuticals. Posted 01-04-08. (Also see: Pulmonary Fibrosis and What is Scleroderma?) |
| Riociguat (BAY63-2521) |
| A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (Patent-1). The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH). This study is currently recruiting participants. clinicaltrials.gov. |
| Bayer Schering Pharma Presents Positive Results Of Phase II Study With Riociguat. Results from the multi-center, open-label, uncontrolled phase II trial, showed that riociguat significantly improved exercise capacity from baseline values in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). Medical News Today. 05/21/09. (Also see: PAH) |
| Discovery of riociguat (BAY 63-2521): a potent, oral stimulator of soluble guanylate cyclase for the treatment of pulmonary hypertension. Riociguat is currently being investigated in phase III clinical trials for the oral treatment of PH after promising results in phase II trials. J Mittendorf. National Institutes of Health PubMed. May 2009 (Also see: PAH) |
| Scleroderma Lung Study II |
| Scleroderma Lung Study II follows Scleroderma Lung Study I, a clinical research study that compared the efficacy and toxicity of daily oral cyclophosphamide (CYC, also called CytoxanTM) with a daily placebo pill for the treatment of scleroderma-related lung fibrosis. |
| Scleroderma Lung Study II. This study compares 2 different medications—daily oral cyclophosphamide (CYC, also called CytoxanTM) with daily oral mycophenolate mofetil (MMF, also called CellceptTM) in the treatment of scleroderma-related pulmonary fibrosis. There are twelve study centers across the U.S. This study is currently recruiting. University of California, Los Angeles. November 2009. (Also see: Pulmonary Fibrosis, Cellcept, and Cytoxan) |
| SCOT Trial |
| Open Enrollment, 2005-2010 |
| SCOT Clinical Trial, which stands for "Scleroderma Cyclophosphamide Or Transplantation", will compare two potential therapies: autologous hematopoietic stem cell transplantation versus high-dose monthly cyclophosphamide. Study dates 2005-2010. ISN. |
| Sildenafil Citrate (Viagra) for Pulmonary Hypertension |
| Continuing Studies, Positive Results |
| To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. A Multinational, Multicentre, Randomized, Parallel Group, Double-Blind Study To Assess The Efficacy and Safety Of 1 mg, 5 mg and 20 mg TID of Oral Sildenafil in the Treatment of Subjects Aged 18 Years and Over With Pulmonary Arterial Hypertension (PAH). January, 2010. clinicaltrials.gov. |
| Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension. The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension. National Taiwan University Hospital. clinicaltrials.gov. |
| Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) (Compass 2). This study will investigate the effects of the combination of bosentan and sildenafil. Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater tha 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg b.i.d. All randomized patients will be treated with study drug until the predefined target number of morbidity/mortality events is reached. clinicaltrials.gov. (Also see: Bosentan) |
| (Also see: Pulmonary Hypertension) |
| Stem Cell Transplants for Scleroderma |
| Continuing Studies, Open Entrollment |
| Stem Cell Transplants (Bone Marrow Transplants) for Early Diffuse Scleroderma. ISN. |
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| Treprostinil (Remodulin) |
| Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine (DISTOL-1). This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Principal Investigator: James Seibold, MD. Started May 2009. ClinicalTrials.gov. (Also see: Digital Ulcers) |
| Twins and Siblings With and Without Autoimmune Diseases |
| Open Enrollment (A 5-year study) |
 Families with Twins or Siblings where one has Systemic Rheumatic Disorders (Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Lupus, Scleroderma, or Myositis) and one does not. The goal of study 03-E-0099 is to assess why one twin or sibling developed disease and why the other brother or sister did not.
The siblings may or may not be twins, but must be of the same gender and be within a 3-year age difference. Biological parents, or, in some cases, children, will also be included in the study.
Families may enroll at the NIH Clinical Center in Bethesda, Maryland, just 9 miles north of Washington, DC or at their local physician’s office. Transportation assistance may be available and there is no charge for study-related evaluations and medical tests.
For information on the study, call the NIH patient recruiting office toll free at 1-800-411-1222 (For TTY: 1-866-411-1010). National Institutes of Health Clinical Center (NIH). 11/25/05. (Also see: Scleroderma Research Registries and Causes of Scleroderma: Genetics) |
| See Also |
Sjögren's Treatments & Clinical Trials
Scleroderma Medical News
Scleroderma Symptoms (treatments are listed for each symptom) |
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