Clinical trials: Systemic Scleroses, Diffuse
Scleroderma
Taking Charge of Systemic Sclerosis
This Study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative…
- Trial name
- TOSS (NCT02494401)
- Testing
- Internet-based self-management program, Scleroderma book
- Where
- United States
- Volunteers
- 267 people
- Sponsor
- University of Michigan
Scleroderma, Systemic, Scleroderma, Diffuse
Effects of FT011 in Systemic Sclerosis
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
- Conditions
- Scleroderma, Systemic, Scleroderma, Diffuse, Sclerosis, Systemic
- Trial name
- NCT04647890
- Testing
- FT011
- Where
- 10 sites in Australia, Netherlands and 3 more
- Volunteers
- 30 people
- Sponsor
- Certa Therapeutics
Diffuse Cutaneous Systemic Sclerosis
A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody…
- Trial name
- NCT04478994
- Testing
- TEPEZZA
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Amgen
Scleroderma, Interstitial Lung Disease
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with dense, thick fibrous tissue. Normally, the immune system helps defend the body against disease and infection.
- Trial name
- SLSII (NCT00883129)
- Testing
- Mycophenolate mofetil, Cyclophosphamide
- Where
- 14 sites in United States
- Volunteers
- 142 people
- Sponsor
- Michael Roth
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
System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis.
- Trial name
- NCT03919799
- Testing
- Belumosudil (KD025)
- Where
- 26 sites in United States
- Volunteers
- 36 people
- Sponsor
- Kadmon, a Sanofi Company
Scleroderma, Systemic
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
To investigate if Riociguat is effective in the treatment of systemic sclerosis
- Trial name
- NCT02283762
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 121 people
- Sponsor
- Bayer
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
Scleroderma, Gastroparesis
TENS in Scleroderma
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis.
- Conditions
- Scleroderma, Gastroparesis, Systemic Sclerosis (SSc)
- Trial name
- NCT06646913
- Testing
- Transcutaneous Electrical Nerve Stimulation
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
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
Systemic Sclerosis, Scleroderma
Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis
Systemic sclerosis is a chronic autoimmune connective tissue disorder with no universally accepted disease modifying regimen. Recruiting patients for systemic sclerosis treatment studies is difficult due to the limited…
- Trial name
- NCT01093885
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Pennsylvania
Scleroderma, Systemic Sclerosis
The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial
Many people living with a rare disease turn to peer-led support groups to cope with their condition and access educational resources.
- Trial name
- SPIN-SSLED-F (NCT03508661)
- Testing
- SPIN-SSLED Program
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Lady Davis Institute
Scleroderma, Scleroderma, Systemic
Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program
Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety…
- Conditions
- Scleroderma, Scleroderma, Systemic, Systemic Sclerosis
- Trial name
- SPIN-CHAT (NCT04335279)
- Testing
- SPIN-CHAT Program
- Where
- Canada
- Volunteers
- 172 people
- Sponsor
- Lady Davis Institute
Systemic Sclerosis, Scleroderma
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis.
- Trial name
- NCT00613171
- Testing
- STI571
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Sclerosis
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
- Trial name
- LOTUSS (NCT01933334)
- Testing
- Pirfenidone
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 63 people
- Sponsor
- Genentech, Inc.
Scleroderma
Hands on - a Hand Care Guide in Systemic Sclerosis
Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.
- Trial name
- NCT02610842
- Testing
- Handbook
- Where
- 2 sites in Brazil
- Volunteers
- 27 people
- Sponsor
- University of Campinas, Brazil
Diffuse Cutaneous Systemic Sclerosis
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
- Trial name
- ASSET (NCT02161406)
- Testing
- Abatacept
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 88 people
- Sponsor
- Dinesh Khanna, MD, MS
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
Lupus Erythematosus, Systemic, Systemic Vasculitis
GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater…
- Conditions
- Lupus Erythematosus, Systemic, Systemic Vasculitis, Isolated Angiitis of Central Nervous System, Lung Disease With Systemic Sclerosis
- Trial name
- LUPRON (NCT01257802)
- Testing
- depot leuprolide acetate 3.75 mg
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Joseph Mccune
Systemic Scleroderma, Severe Systemic Sclerosis
Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis
The purpose of the study is to examine the safety and effectiveness of a reduced intensity conditioning regimen and allogeneic bone marrow transplant for people with systemic sclerosis.
- Trial name
- NCT00622895
- Testing
- fludarabine phosphate, Mycophenolic Acid, tacrolimus
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Fred Hutchinson Cancer Center