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Department of Medicine

Department of Medicine

  Division of Rheumatology and Clinical Immunology

RESEARCH


Ongoing Clinical Trials


Myositis


1. Banking of Biological Samples and Collection of Clinical Data for Connective Tissue Disease Research

Connective tissue diseases are chronic diseases that involve damage of connective tissues such as the lining of the joints, blood vessel walls, muscle, skin, and certain internal organs. These diseases are also known as autoimmune diseases because the body's own immune system attacks its own tissues. Treatment has improved over the past 20 years, but there is still much that is not understood about the complications, causes, and treatments of these diseases. The purpose of this project is to set up and maintain a Rheumatology Biological Specimen Bank of blood and tissue samples and a parallel Research Databank of computerized medical information. This is to support research of the CTDs and the factors that contribute to the onset and course of these diseases. Inclusion Criteria: all ages, male or female, diagnosed by a doctor within the Department of Rheumatology with a CTD.
Contact: Diane Koontz (412) 383-8674
Status: Actively Recruiting

2. Genentech Protocol No. ML28681. A multi-center, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of tocilizumab in adults with refractory dermatomyositis and polymyositis.

Lay Summary: This investigator-initiated (Oddis et al) study is designed to determine the efficacy, safety and tolerability of tocilizumab in adults with dermatomyositis or polymyositis. Participants will complete 10 study visits over a 48 week period. Participants will be randomized (like a flipping a coin) to receive either tocilizumab or placebo (an inactive agent, like a sugar pill). Study procedures include: questionnaires, laboratory studies (blood draw), manual muscle testing, a brief physical exam, and optional muscle biopsy. Participants will receive the study drug, and all other study procedures at no cost. If you have any questions regarding this research trial, please contact the study coordinator.
Contact: Diane Koontz - (412) 383-8674
Status:
Actively Recruiting

Physician Summary: Genentech, Inc. is sponsoring a multi-center, double-blind, randomized placebo-controlled proof of concept pilot study to evaluate the efficacy and tolerability of tocilizumab (TCZ) in adult dermatomyositis (DM) and polymyositis (PM) patients that have failed (or are considered intolerant to) an adequate course of glucocorticoids or have failed glucocorticoids plus at least one other immunosuppressive (IS) or immunomodulatory agent (e.g. methotrexate, azathioprine, cyclosporine, tacrolimus, mycophenolate mofetil, cyclophosphamide, IVIg, anti-TNF agent, and rituximab). Participants must be 18 years of age or older with "definite" or "probable" DM or PM according to the criteria of Bohan and Peter. 40 participants will be randomly assigned to TCZ or placebo in a 1:1 ratio (approximately 20 per arm). Participants will complete 10 study visits during this 48-week clinical trial. Study drug will be provided at no cost to participants. If you have questions regarding this trial, please contact the study coordinator.

3. Environmental Risk Factors for the Anti-Synthetase Syndrome ("MYORISK Study")

This study intends to investigate the genetic and environmental risk factors involved in the development of myositis, an autoimmune muscle disease that causes chronic muscle weakness. Adults diagnosed with myositis within the last two years may enroll by completing questionnaires and donating blood samples.

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.
Contact: Diane Koontz (412) 383-8674
Status: Actively Recruiting


Myositis: Anticipated Trials

1. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with Dermatomyositis

This multi-center study initiated by Idera has the primary objective of assessing the safety and tolerability of IMO-8400 in adult patients with dermatomyositis (DM) with active skin and muscle disease and to assess the effect of IMO-8400 on the cutaneous manifestations of DM. Exploratory objectives will investigate the treatment effects of study drug on indices of disease activity, patient-reported outcomes and pharmacodynamic measures. IMO-8400 is an antagonist to Toll-like receptors (TLRs) 7, 8, and 9 and blocking TLR activation represents a potential mechanism for interrupting the inflammatory cycle offering a potential treatment approach for patients with DM.

2. Prospective, Double-blind, Randomized, Phase III Study Evaluating Efficacy and Safety of Human Immunoglobulin in Patients With Dermatomyositis

The primary objective of this multicenter study is to provide confirmatory data on the beneficial effect of 2.0 g/kg of human immunoglobulin every four weeks compared to placebo in subjects with active dermatomyositis (DM) based on the percentage of responders at Week 16. Patients will receive double-blinded treatment at 4-week intervals of either Ig or placebo. There is a 16-week efficacy period followed by a 24-week open-label extension period.