Subscribe

Select Ongoing Trials Currently Enrolling Patients with Scleroderma

Rheumatology Practice Management February 2018 Vol 6 No 1 - Clinical Trials Tracker

 

The following clinical trials represent a selection of key studies that are currently recruiting patients with scleroderma for inclusion in investigations of new therapies and new regimens of existing treatments for individuals with the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with Clinical Trials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1. Effect of Atorvastatin on Blood Vessel Function and Raynaud Symptoms

The objective of this randomized, parallel-assignment, phase 2 clinical trial is to assess the effect that atorvastatin has on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis. Patients aged 18 to 70 years with early diffuse scleroderma and Raynaud phenomenon may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive atorvastatin 40 mg or placebo, once daily for 16 weeks.

The primary outcome measure is the effect atorvastatin has on changes in microvascular endothelial function. The secondary outcome measures are the effect atorvastatin has on changes in Raynaud symptoms, microcirculatory flow, and macrovascular endothelial function. This study plans to enroll 30 patients at the University of Pittsburgh, PA. For more information, contact Dana Ivanco at 412-648-7040 or des2@pitt.edu, or Maureen Laffoon at 412-648-5037 or laffoonm@pitt.edu. The NLM Identifier is NCT02370784.

2. Safety of Dabigatran Etexilate in Patients with Scleroderma and Interstitial Lung Disease

This single-group phase 1 clinical trial will determine the safety of using dabigatran etexilate for the treatment of patients with scleroderma and interstitial lung disease. Patients aged 18 to 70 years with scleroderma diagnosed in accordance with American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria may be eligible for enrollment if other criteria are met. All eligible patients will be given dabigatran etexilate 75 mg twice daily for 6 months.

The primary outcome measure is the safety of dabigatran etexilate, based on complete blood counts, comprehensive metabolic profiles, and coagulation studies. The secondary outcome measure is the efficacy of the trial drug in treating scleroderma. This study expects to enroll 15 patients at the Medical University of South Carolina, Charleston. For more information, contact Kelley Gibson at 843-792-5290 or gibsonke@musc.edu. The NLM Identifier is NCT02426229.

3. Safety and Efficacy of Riociguat in Patients with Scleroderma-Associated Digital Ulcers

The objective of this randomized, double-blind, placebo-controlled, parallel-assignment, phase 2 clinical trial is to evaluate the safety and efficacy of using riociguat 3 times daily in patients with scleroderma-associated digital ulcers. Patients aged ≥18 years with systemic sclerosis diagnosed in accordance with ACR/EULAR criteria who have ≥1 active ischemic digital ulcers at baseline that are at or distal to the proximal interphalangeal joint, and that developed or worsened in the 8 weeks leading up to screening may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive riociguat or placebo.

The primary outcome measure is the change in digital ulcer net burden from baseline to end of treatment. The secondary outcome measures include health-related quality of life, physical function, and healing of pressure ulcers over the distal interphalangeal, proximal interphalangeal, metacarpophalangeal, and elbows. This study expects to enroll 20 patients at locations in Pennsylvania, Utah, New York, Michigan, and Washington, DC. For more information, contact Donna DiFranco at 734-764-7374 or donnadi@med.umich.edu, or Erica Bush at 734-936-5615 or ebush@med.umich.edu. The NLM Identifier is NCT02915835.

4. Safety and Tolerability of Brentuximab Vedotin in Patients with Diffuse Cutaneous Systemic Sclerosis

This multicenter, double-blind, placebo-controlled, dose-escalation, phase 1/2 clinical trial will determine the safety and tolerability of brentuximab vedotin in patients with cutaneous systemic sclerosis. Patients aged 18 to 70 years with systemic sclerosis in accordance with ACR/EULAR criteria may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive brentuximab vedotin or placebo.

The primary outcome measure is the percentage of patients who have ≥1 adverse events that are grade ≥3. The secondary outcome measures include the percentage of patients who have grade ≥2 adverse events and grade ≥2 peripheral neuropathy. Changes from baseline in predicted forced vital capacity and in health-related quality of life will also be measured, along with other exploratory outcome measures. This study expects to enroll 24 patients at multiple locations across the United States. For more information, contact Jennifer Raymond at 310-206-4112 or jraymond@mednet.ucla.edu, or Anna Yusov at 212-774-7620 or yusova@hss.edu. The NLM Identifier is NCT03222492.

5. Use of GSK2330811 in Patients with Diffuse Cutaneous Systemic Sclerosis

The objective of this multicenter, double-blind, placebo-controlled, phase 2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of using repeat subcutaneous doses of GSK2330811, a humanized monoclonal antibody, for the treatment of patients with diffuse cutaneous systemic sclerosis. Patients aged ≥18 years with a documented diagnosis of systemic sclerosis with diffuse cutaneous involvement and a modified Rodnan skin score ≥10 and ≤35 at screening may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive GSK2330811 or placebo.

The primary outcome measures include safety and tolerability, which will be gleaned through hematology, clinical chemistry, and urinalysis, as well as systolic and diastolic blood pressure. The secondary outcome measures include plasma concentrations of GSK2330811 and incidence and titers of anti-GSK2330811 antibodies. This study plans to enroll 40 patients at multiple locations across the United States and the United Kingdom. For more information, contact the US GSK Clinical Trials Call Center at 877-379-3718 or GSKClinicalSupportHD@gsk.com. The NLM Identifier is NCT03041025.

6. Safety and Tolerability of Tofacitinib in Patients with Early Diffuse Cutaneous Systemic Sclerosis

This randomized, parallel-assignment, placebo-controlled, phase 1/2 clinical trial will determine the safety and tolerability of using tofacitinib for the treatment of patients with diffuse cutaneous systemic scleroderma. Patients aged 18 to 70 years with systemic sclerosis diagnosed in accordance with 2013 ACR/EULAR criteria may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive tofacitinib or placebo.

The primary outcome measure is the incidence of adverse events and serious adverse events. The secondary outcome measures include changes in modified Rodnan skin score and adverse events of special interest. This study expects to enroll 15 patients at the University of Michigan, Ann Arbor. For more information, contact Erica Bush, at 734-936-5615 or ebush@med.umich.edu. The NLM Identifier is NCT03274076.

7. Nonmyeloablative Conditioning and Allogeneic Bone Marrow Transplant in Patients with Systemic Sclerosis

The objective of this single-group, phase 1/2 clinical trial is to assess the safety and efficacy of using a reduced-intensity conditioning regimen and allogeneic bone marrow transplantation for the treatment of patients with systemic sclerosis. Patients aged ≤70 years with severe systemic sclerosis diagnosed in accordance with ACR criteria, and who have a human leukocyte antigen–identical bone marrow donor available and willing to donate may be eligible for enrollment if other criteria are met. Eligible patients will undergo allogeneic hematopoietic cell transplantation after receiving reduced-intensity conditioning.

The primary outcome measure is event-free survival. The secondary outcome measures include overall survival, regimen-related toxicity, and quality of life. This study plans to enroll 20 patients at the Colorado Blood Cancer Institute, Denver, and the Fred Hutchinson/University of Washington Cancer Consortium, Seattle. For more information, contact Richard A. Nash at 720-754-4800 or Richard.Nash@HealthONECares.com, or George E. Georges at 206-667-6886 or ggeorges@fredhutch.org. The NLM Identifier is NCT00622895.

Related Items
Select Ongoing Trials Currently Enrolling Patients with Juvenile Idiopathic Arthritis
Rheumatology Practice Management December 2017 Vol 5 No 6 published on January 8, 2018 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Lupus
Rheumatology Practice Management October 2017 Vol 5 No 5 published on October 20, 2017 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Rheumatoid Arthritis
Rheumatology Practice Management August 2017 Vol 5 No 4 published on August 16, 2017 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Fibromyalgia
Rheumatology Practice Management June 2017 Vol 5 No 3 published on June 28, 2017 in Clinical Trials Tracker
Select Ongoing Clinical Trials Currently Enrolling Patients with Osteoarthritis
Rheumatology Practice Management April 2017 Vol 5 No 2 published on April 25, 2017 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Psoriatic Arthritis
Rheumatology Practice Management February 2017 Vol 5 No 1 published on March 2, 2017 in Clinical Trials Tracker
Select Ongoing Clinical Trials Currently Enrolling Patients with Scleroderma
Rheumatology Practice Management December 2016 Vol 4 No 6 published on December 28, 2016 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Lupus
Rheumatology Practice Management October 2016 Vol 4 No 5 published on October 28, 2016 in Clinical Trials Tracker
Select Clinical Trials Currently Recruiting Patients with Prostate Cancer
Urology Practice Management - October 2016, Vol 5, No 5 published on October 10, 2016 in Clinical Trials Tracker
Select Ongoing Clinical Trials Currently Enrolling Patients with Juvenile Idiopathic Arthritis
Rheumatology Practice Management August 2016 Vol 4 No 4 published on August 25, 2016 in Clinical Trials Tracker
Last modified: March 19, 2018
  • American Health and Drug Benefits
  • Lynx CME
  • Value Based Care in Rheumatology
  • Oncology Practice Management
  • Urology Practice Management

Search