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Polymyositis clinical trials

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NCT ID: NCT02043548 Completed - Dermatomyositis Clinical Trials

Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis

TIM
Start date: October 1, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this multi-center pilot study is to determine if the drug tocilizumab (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM) and dermatomyositis (DM).

NCT ID: NCT01906372 Completed - Dermatomyositis Clinical Trials

Acthar in Treatment of Refractory Dermatomyositis and Polymyositis

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness without a rash. The study doctors want to evaluate whether ACTH Gel will improve the symptoms of this disease. This drug is approved by the Food and Drug Administration (FDA) for dermatomyositis (DM) and polymyositis (PM). ACTH gel has been an FDA-approved treatment for myositis since 1952, and in 2010 the FDA retained PM and DM as diseases approved for ACTH gel use.

NCT ID: NCT01813617 Completed - Dermatomyositis Clinical Trials

Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis

Start date: September 2010
Phase: N/A
Study type: Observational [Patient Registry]

Most patients respond to medical treatment with corticosteroids and immunosuppressive treatment, but a majority of patients develop sustained muscle impairment. The aim of this study was to evaluate the outcome of muscle endurance assessed with the Functional Index-2 (FI-2), muscle strength assessed by the MMT-8 and disease activity assessed by the six item core set at 6 and 12 months following diagnosis in patients with polymyositis (PM) and dermatomyositis (DM). 72 patients diagnosed with probable or definite PM or DM 2003-2010 who performed the FI-2 and the MMT at the time of diagnosis were included in this Swedish Myositis Register study. All patients had performed both the Functional Index-2 assessing muscle endurance and the Manual Muscle test (MMT) assessing isometric muscle strength. Physician Global assessment based on the evaluation of the consensus recommended six item core set for disease activity assessment was also included. Data were analysed on group levels as well as with criteria for individual responder criteria. A responder was identified as improving at least 20 % compared to baseline.

NCT ID: NCT01801917 Terminated - Polymyositis Clinical Trials

Efficacy and Tolerability of BAF312 in Patients With Polymyositis

Start date: April 24, 2013
Phase: Phase 2
Study type: Interventional

This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).

NCT ID: NCT01734369 Completed - Dermatomyositis Clinical Trials

Environmental Risk Factors for Myositis in Military Personnel

Start date: March 13, 2014
Phase:
Study type: Observational

Background: - Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It can cause muscle weakness, swelling, and pain. It can develop in people with no history of muscle problems. Environmental exposures may determine who develops myositis. Genes may also affect development of the disease. - Some people who serve in the military develop myositis. However, other military personnel do not. Researchers want to compare military personnel with and without myositis. They will look for common factors that might have led to the disease. Objectives: - To study environmental risk factors for myositis in military personnel. Eligibility: - Military personnel who developed myositis during their period of service. - Healthy military personnel who do not have myositis or another autoimmune disease. Design: - Participants will have a physical exam and medical history. - Participants will fill out forms about environmental exposures, particularly while in the military. The questions will ask about past infections, vaccines and medications, and personal habits. They will also ask about participants occupations during military service and their deployments. - Participants will also provide blood samples for study. - No treatment will be provided as part of this study.

NCT ID: NCT01637064 Enrolling by invitation - Dermatomyositis Clinical Trials

Dermatomyositis and Polymyositis Registry

ADAPT
Start date: April 2013
Phase: N/A
Study type: Observational

By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.

NCT ID: NCT01432613 Completed - Dermatomyositis Clinical Trials

Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

DARWIM
Start date: December 22, 2010
Phase: N/A
Study type: Interventional

Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The main aim of this interventional study is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.

NCT ID: NCT01415219 Completed - Dermatomyositis Clinical Trials

Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Start date: March 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.

NCT ID: NCT01315938 Completed - Dermatomyositis Clinical Trials

Abatacept Treatment in Polymyositis and Dermatomyositis

ARTEMIS
Start date: January 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of abatacept in patients with Dermatomyositis (DM) and polymyositis (PM) refractory to conventional treatment using a randomised trial design with delayed start in one arm. Abatacept will be administered intravenously to participants at a dose based on body weight at the screening visit followed by six follow-up treatments (Active treatment arm). Abatacept will also be administered intravenously to participants at a dose based on body weight starting at 3 months followed by six follow-up treatments (Delayed-onset treatment arm). The International Myositis Assessment and Clinical Studies Group (IMACS) preliminary definition of improvement (DOI) will be used for assessment.

NCT ID: NCT01276470 Recruiting - Dermatomyositis Clinical Trials

Environmental Risk Factors for the Anti-synthetase Syndrome

Start date: February 9, 2011
Phase:
Study type: Observational

Background: - Like other complex diseases, autoimmune diseases are the result of numerous causes, including genetic and environmental factors. Some researchers believe that people who are susceptible to autoimmune disorders develop them when the body reacts to environmental or other factors by creating white blood cells that attack the body s own tissues, which then progresses to autoimmune diseases. These immune-triggered disorders can overlap with one another to some extent, but most autoimmune diseases have certain distinct triggers. - The autoimmune disorder myositis weakens the muscles and may cause other health problems. Environmental exposures associated with myositis include ultraviolet radiation, stressful life events and muscle overexertion, collagen implants, infections such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some individuals with myositis also produce proteins in the blood called autoantibodies that react with certain parts of the person s own cells, called synthetases, which are involved in making new proteins. A syndrome called the anti-synthetase syndrome, which includes myositis and lung disease, is associated with having the anti-synthetase autoantibodies. Researchers are interested in studying differences in environmental exposures in individuals with myositis. This study is being conducted to determine if persons with the anti-synthetase syndrome have had different environmental exposures before disease onset compared with other patients with myositis who do not have this syndrome and also compared with healthy volunteers. Objectives: - To determine whether selected infectious and noninfectious environmental exposures are more common in individuals who have myositis with the anti-synthetase syndrome, compared with healthy volunteers. Eligibility: - Individuals who have been diagnosed with myositis (with or without anti-synthetase autoantibodies), and healthy volunteers without autoimmune disorders. Design: - Participants will be screened with a full medical history and physical examination, and will provide blood, urine and house dust samples. - Participants will complete questionnaires about their medical history and the types of exposures they have had at work, at home, and elsewhere. Participants who have myositis will also be asked about certain infections, heavy exercise or physical exertion, sun exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with the disease. Healthy volunteers will be asked about the same exposures before the date of diagnosis of disease of the myositis subject to which they have been matched. - Participants will receive a kit that contains instructions and a filter to be put onto their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for possible future analyses of infectious or toxic agents based on the other results from the study. - Individuals with myositis will have other tests as clinically indicated, including lung function tests and imaging studies.