Clinical trials: Scleroderma
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
Systemic Sclerosis, Scleroderma
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc).
- Trial name
- TOFA-SSc (NCT03274076)
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- University of Michigan
Raynaud, Scleroderma
A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon
Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and…
- Trial name
- NCT00498615
- Testing
- Fasudil
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Johns Hopkins University
SYSTEMIC SCLERODERMA
Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma
Scleroderma is a systemic disorder categorized as an immunologically mediated disease that causes collagen deposition of skin and visceral organs.
- Trial name
- NCT00278525
- Testing
- standard of care, stem cell transplantation
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Northwestern University
Scleroderma, Systemic
Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis
GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis (SSc), a rare autoimmune disease with high morbidity and mortality.
- Trial name
- NCT03041025
- Testing
- GSK2330811
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
Scleroderma, Digital Ulcers
Riociguat in Scleroderma Associated Digital Ulcers
The primary objective of this study is to provide preliminary data on the efficacy (digital ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with…
- Trial name
- RESCUE (NCT02915835)
- Testing
- Riociguat
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Dinesh Khanna, MD, MS
Graft Versus Host Disease, Systemic Scleroderma
Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
This randomized phase II trial is evaluating how well imatinib mesylate works compared to rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease (GVHD).
- Trial name
- NCT01309997
- Testing
- imatinib mesylate, rituximab
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Lee, Stephanie
Systemic Sclerosis
Open-Label Study of Oral Treprostinil in Digital Ulcers
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects…
- Trial name
- DISTOL-EXT (NCT00848107)
- Testing
- treprostinil diethanolamine
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 115 people
- Sponsor
- United Therapeutics
Systemic Sclerosis, Scleroderma
Cardiac Safe Transplants for Systemic Sclerosis
This study is designed to treat systemic sclerosis (scleroderma) patients with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy that is less toxic to your heart.
- Trial name
- CAST (NCT03593902)
- Testing
- Rituximab, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Northwestern University
Systemic Sclerosis, Ulcers
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration.
- Trial name
- DUAL-1 (NCT01474109)
- Testing
- macitentan 3mg, macitentan 10mg
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 289 people
- Sponsor
- Actelion
Microstomia, Systemic Sclerosis
The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients
Systemic sclerosis is a systemic disease which may involve multiple organ systems and cause functional disabilities. Microstomia is one of the most common complications of the disease which may result in difficulties performing…
- Trial name
- NCT04336475
- Testing
- orofacial exercise program
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Cukurova University
Systemic Sclerosis-associated Interstitial Lung Disease
Abituzumab in SSc-ILD
The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the…
- Trial name
- NCT02745145
- Testing
- Abituzumab 1500 mg, Abituzumab 500 mg
- Where
- 55 sites in United States, Argentina and 7 more
- Volunteers
- 24 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Systemic Scleroderma, Pulmonary Hypertension
Placebo Controlled Trial of Bosentan in Scleroderma Patients
The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.
- Trial name
- NCT00377455
- Testing
- Bosentan
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Georgetown University
Lung Diseases, Interstitial
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
- Trial name
- NCT03313180
- Testing
- Nintedanib
- Where
- 159 sites in United States, Argentina and 28 more
- Volunteers
- 444 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Arterial Hypertension, Systemic Sclerosis
A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis
This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease…
- Conditions
- Pulmonary Arterial Hypertension, Systemic Sclerosis, Scleroderma Spectrum of Diseases, Connective Tissue Disease
- Trial name
- ATPAHSS (NCT01042158)
- Testing
- tadalafil and ambrisentan upfront combination therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Johns Hopkins University
Digital Ulcers
Bosentan in Digital Ulcers
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).
- Trial name
- RAPIDS 2 OL (NCT00319696)
- Testing
- Bosentan 62.5 mg, Bosentan 125 mg
- Volunteers
- 116 people
- Sponsor
- Actelion
Scleroderma, Systemic
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality.
- Trial name
- NCT02597933
- Testing
- Nintedanib
- Where
- 195 sites in United States, Argentina and 30 more
- Volunteers
- 580 people
- Sponsor
- Boehringer Ingelheim
Systemic Sclerosis
Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis
This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose…
- Trial name
- NCT01670565
- Testing
- Belimumab, Mycophenolate Mofetil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hospital for Special Surgery, New York
Scars, Scleroderma
Laser Treatment for the Improvement of Scars and Scleroderma
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.
- Trial name
- NCT04567537
- Testing
- Laser Treatment
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital