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Rheumatology Practice Management December 2016 Vol 4 No 6 - 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 ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Safety and Efficacy of Intravenous Immunoglobulin

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to evaluate the safety and efficacy of using intravenous (IV) immunoglobulin in patients with scleroderma. Patients from both sexes aged ≥18 years who have diffuse systemic sclerosis with active skin involvement that has not improved or worsened in the past 4 months despite treatment with methotrexate, mycophenolate mofetil, azathioprine, or an anti–tumor necrosis factor agent may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive IV immunoglobulin or placebo.

The primary outcome measure is the effect of IV immunoglobulin on the skin of patients with scleroderma. Secondary outcome measures include the toxicity of IV immunoglobulin in patients with scleroderma, as well as the effects of the treatment on pulmonary function. This study plans to enroll 24 patients at Georgetown University Hospital, Washington, DC, and Johns Hopkins Hospital, Baltimore, MD. For more information, contact Virginia D. Steen, MD, at 202-444-6200, or Maia Zulmatashvili at 202-444-6210 or mz381@georgetown.edu. The NLM Identifier is NCT01785056.

2 Abituzumab for the Treatment of Patients with Systemic Sclerosis–Associated Interstitial Lung Disease

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will assess the safety and efficacy of using abituzumab for the treatment of patients with systemic sclerosis–associated interstitial lung disease. Patients from both sexes aged 18 to 75 years who meet the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for classification of systemic sclerosis, who have received mycophenolate for ≥6 months before the screening visit, and who have no significant renal impairment may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive abituzumab 1500 mg or 500 mg, or placebo.

The primary outcome measure is the annual rate of absolute forced vital capacity change in volume. Secondary outcome measures include changes in dyspnea from baseline according to the Mahler Transition Dyspnea Index, and overall survival. This study expects to enroll 175 patients at multiple locations across the United States and abroad. For more information, contact 888-275-7376. The NLM Identifier is NCT02745145.

3 Nintedanib versus Placebo for Patients with Systemic Sclerosis–Associated Interstitial Lung Disease

The objective of this randomized, double-blind, placebo-controlled, phase 3 clinical trial is to evaluate the safety and efficacy of using oral nintedanib 150 mg for the treatment of patients with sclerosis-associated interstitial lung disease. Patients from both sexes aged ≥18 years who meet the 2013 ACR/EULAR criteria for classification of systemic sclerosis, and who have sclerosis-associated interstitial lung disease may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nintedanib or placebo.

The primary outcome measure is the annual rate of decline in forced vital capacity volume. Secondary outcome measures include time to all-cause mortality and the absolute change from baseline in digital ulcer net burden. This study plans to enroll 520 patients at multiple locations across the United States and abroad. For more information, contact the Boehringer Ingelheim Call Center at 800-243-0127 or clintriage.rdg@boehringeringelheim.com. The NLM Identifier is NCT02597933.

4 Subcutaneous Abatacept for Patients with Diffuse Cutaneous Systemic Sclerosis

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will compare the safety and efficacy of using abatacept for the treatment of patients with diffuse cutaneous systemic sclerosis with that of placebo. Patients from both sexes aged ≥18 years who meet the 2013 ACR/EULAR criteria for a diagnosis of systemic sclerosis, who have diffuse systemic sclerosis as defined by LeRoy and Medsger, and who do not have an infected ulcer before trial randomization may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive abatacept or placebo.

The primary outcome measures are the occurrence of adverse events and serious adverse events, and changes from baseline in the modified Rodnan skin score at month 12. Secondary outcome measures include changes in patient-reported outcomes, and changes in the percentage of predicted forced vital capacity. This study expects to enroll 86 patients at multiple locations across the United States and abroad. For more information, contact Teneisha Podczervinski, MBA, at 734-763-7810 or tpodczer@med.umich.edu, or Bev Marchant, RN, at 734-615-3196 or bevm@med.umich.edu. The NLM Identifier is NCT02745145.

5 Rituximab for Patients with Systemic Sclerosis–Associated Pulmonary Arterial Hypertension

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to determine whether rituximab has a beneficial effect on clinical disease progression in patients with systemic sclerosis–associated pulmonary arterial hypertension, with minimal toxicity. Patients from both sexes aged 18 to 75 years who have been diagnosed with systemic sclerosis–associated pulmonary arterial hypertension in the past 5 years, and who have a mean pulmonary vascular resistance of >3 Wood units may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive rituximab or placebo.

The primary outcome measure is the change in pulmonary vascular resistance. Secondary outcome measures include assessment of time to clinical worsening, the number of new digital ulcers, and change in quality of life from baseline. This study plans to enroll 60 patients at multiple locations across the United States. For more information, contact Val Scott at 650-725-8082 or valscott@stanford.edu, or Rachel Broderick at 917-715-4675 or rb3173@cumc.columbia.edu. The NLM Identifier is NCT01086540.

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

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will compare the safety and efficacy of using riociguat for the treatment of patients with scleroderma-associated digital ulcers with that of placebo. Patients from both sexes aged ≥18 years who meet the 2013 ACR/EULAR criteria for a diagnosis of systemic sclerosis, and who have ≥1 active and visible digital ulcers located at or distal to the proximal interphalangeal joint at baseline, which developed or worsened within 8 weeks prior 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 from baseline in digital ulcer net burden. Secondary outcome measures include the healing of cardinal digital ulcers, the development of digital ulcers, and the time to healing of all digital ulcers. This study expects to enroll 20 patients at centers in Washington, DC, Ann Arbor, MI, Pittsburgh, PA, Salt Lake City, UT, and New York, NY. 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.

7 Efficacy and Safety of Riociguat for Patients with Diffuse Cutaneous Systemic Sclerosis

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to determine whether riociguat is an effective treatment for patients with systemic sclerosis. Patients from both sexes aged ≥18 years who meet the 2013 ACR/EULAR criteria for a diagnosis of systemic sclerosis, and have diffuse cutaneous systemic sclerosis according to the LeRoy criteria 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 modified Rodnan skin score. Secondary outcome measures include changes in the predicted percentage of forced vital capacity, and Health Assessment Questionnaire–Disability Index domains. This study plans to enroll 130 patients at multiple locations across the United States and abroad. For more information, contact Bayer Clinical Trials at clinicaltrialscontact@bayerhealthcare.com. The NLM Identifier is NCT02283762.

8 Safety and Appropriateness of Dabigatran Etexilate for Patients with Scleroderma

This open-label, single-group, phase 1 clinical trial will evaluate the safety of using dabigatran etexilate for the treatment of patients with scleroderma and interstitial lung disease. Patients from both sexes aged 18 to 70 years who meet the ACR/EULAR criteria for a diagnosis of systemic sclerosis, who have had the condition for <7 years, and who are not currently enrolled in any other clinical trials may be eligible for enrollment if other criteria are met. Eligible patients will receive dabigatran etexilate.

The primary outcome measure is the safety of using dabigatran etexilate in patients with scleroderma and interstitial lung disease. The secondary outcome measure is the preliminary estimate of the efficacy of dabigatran etexilate in patients with 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.

9 Atorvastatin Use in Patients with Early Diffuse Scleroderma

The objective of this randomized, double-blind, parallel-assignment, phase 2 clinical trial is to evaluate the effect of atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis. Patients from both sexes aged 18 to 70 years who have early diffuse scleroderma and Raynaud phenomenon may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive atorvastatin or placebo.

The primary outcome measure is the effect that atorvastatin has on any changes in microvascular endothelial function. Secondary outcome measures include the effect of the trial drug on changes in Raynaud symptoms, and on changes in microcirculatory flow. 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.

10 Safety and Efficacy of Oral Treprostinil for the Treatment of Calcinosis

This open-label, single-group, phase 2 clinical trial will evaluate the safety and efficacy of using oral treprostinil for the treatment of calcinosis in patients with systemic sclerosis. Patients from both sexes aged ≥18 years who meet the 2013 ACR/EULAR criteria for a diagnosis of limited or diffuse cutaneous systemic sclerosis, and who are without diverticulosis may be eligible for enrollment if other criteria are met. Eligible patients will receive oral treprostinil.

The primary outcome measures are the number of patients who have treatment-related adverse events and the mean rate of calcinosis change. The secondary outcome measures include the effect of oral treprostinil on changes in Scleroderma Health Assessment Questionnaire scores, and in Raynaud Condition Scores. This study expects to enroll 12 patients at the Stanford University School of Medicine, Palo Alto, CA. For more information, contact Lorinda S. Chung, MD, MS, at 650-723-6961, or Antonia Maria Valenzuela Vergara, MD, MS, at 650-723-6961 or antoniav@stanford.edu. The NLM Identifier is NCT02663895.

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Last modified: January 4, 2017
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