Clinical trials: Diffuse Scleroderma
Influenza Vaccine in Scleroderma
Influenza Vaccination in Patients With Scleroderma
The safety and efficacy of vaccination against influenza in patients with scleroderma is not clear. The objective of this study is to assess its safety and efficacy in 50 patients with scleroderma in comparison with 30 controls
- Trial name
- NCT01002508
- Testing
- Influenza vaccine
- Where
- Israel
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
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
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
- Trial name
- Breakfree-SSc (NCT07335562)
- Testing
- BMS-986353, Fludarabine, Cyclophosphamide
- Where
- 56 sites in United States, Belgium and 8 more
- Volunteers
- 92 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Scleroderma
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active…
- Trial name
- LIBERIUS (NCT05726630)
- Testing
- Divozilimab
- Where
- 3 sites in Russia
- Volunteers
- 152 people
- Sponsor
- Biocad
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Raynaud Phenomenon Due to Trauma, Raynaud Disease
Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud
Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in patients with secondary Raynaud's phenomenon (RP).
- Conditions
- Raynaud Phenomenon Due to Trauma, Raynaud Disease, System; Sclerosis, Lupus Erythematosus, Systemic
- Trial name
- NCT03027674
- Testing
- 10% nifedipine cream, 5% sildenafil cream
- Where
- Chile
- Volunteers
- 10 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Refractory Lupus Nephritis, Systemic Sclerosis
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension…
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Trial name
- NCT06947460
- Testing
- CD19-BCMA CAR-T cells infusion
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Beijing GoBroad Hospital
Scleroderma, Autoimmune Diseases
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
- Trial name
- NCT05085444
- Testing
- Assigned Interventions CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Zhejiang University
Systemic Sclerosis
Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma). II.
- Trial name
- NCT00004380
- Testing
- relaxin
- Volunteers
- 1 people
- Sponsor
- National Center for Research Resources (NCRR)
Rheumatoid Arthritis, Spondyloarthritis
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Systemic Lupus Erythematosus (SLE), Dermatomyositis (DM)
- Trial name
- NCT01151644
- Testing
- Anti-pandemic H1N1 influenza vaccine
- Where
- Brazil
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
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 (SSc), Scleroderma
Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
It is recommended to focus on the physical functionality, chewing, and swallowing performance of individuals diagnosed with scleroderma.
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized
- Trial name
- NCT07182981
- Testing
- Questionnaire application for child and adult scleroderma patients
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hacettepe University
Systemic Sclerosis, Systemic Lupus Erythematosus
Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected peripheral blood stem cell (PBSC)…
- Conditions
- Systemic Sclerosis, Systemic Lupus Erythematosus, Dermatomyositis, Juvenile Rheumatoid Arthritis
- Trial name
- NCT00010335
- Testing
- Stem Cell Transplantation, CD34 selection
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Fred Hutchinson Cancer Center
Systemic Sclerosis, Dermatomyositis
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare.
- Conditions
- Systemic Sclerosis, Dermatomyositis, iPPSD2
- Trial name
- ITS-PILOT (NCT03582800)
- Testing
- STS
- Where
- 11 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Limoges
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
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
Scleroderma, Systemic
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
The aim of the study is evaluating the efficacy of organized education process of the modified Rodnan Skin Score (MRSS) in the systemic sclerosis.
- Trial name
- NCT03219606
- Testing
- Organized education course of Modified Rodnan Skin Scoring
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Seoul National University Hospital
Lung Diseases, Interstitial
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients…
- Trial name
- NCT04325217
- Testing
- Nintedanib
- Where
- Japan
- Volunteers
- 586 people
- Sponsor
- Boehringer Ingelheim
Scleroderma, Localized, Morphea
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country.
- Conditions
- Scleroderma, Localized, Morphea, Frontal Linear Scleroderma en Coup de Sabre, Scleroderma, Circumscribed
- Trial name
- MAC (NCT01808937)
- Testing
- Morphea
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Systemic Sclerosis, Cardiac Diseases
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and…
- Conditions
- Systemic Sclerosis, Cardiac Diseases, Heart Block, Cardiac Arrhythmia
- Trial name
- NCT01829126
- Where
- 11 sites in France, Germany and 4 more
- Volunteers
- 765 people
- Sponsor
- Gabriele Valentini