The Myositis Registry and Repository - 2016

October 06, 2016

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

David R. Fernandez, MD

Co-Investigators

Robert F. Spiera, MD
Teena Shetty, MD
Jessica K. Gordon, MD
Annel Fernandez
Emily Bakaj
Alexandra Morquette

Summary

The purpose of the Myositis Registry is to gather as much information as we can about as many patients as possible who have this rare condition.  This will facilitate investigators in developing a better understanding of its clinical features, pathobiology (the study of the biological changes in the body caused by disease), and genetic links. With this increased knowledge, investigators hope to identify the unmet needs of patients with myositis and develop new and better treatments to improve disease outcomes and quality of life. Patients will be asked to allow researchers to gather information about their background and medical history, obtain and store their blood, serum, plasma, and tissue samples and gather clinical information on them. A maximum of 100 patients per year will be enrolled during the course of this registry. After the baseline visit, follow up visits are every 3-4 months.

Inclusion/Exclusion Criteria

Inclusion:

• Participants must have been diagnosed with adult dermatomyositis, polymyositis, inclusion body myositis, or immune-mediated necrotizing myopathy. Dermatomyositis patients may include amyopathic and hypomyopathic dermatomyositis..
•  Inclusion body myositis patients will require a muscle biopsy report indicating presence of inclusion bodies.
•  Patients who do not have inclusion body myositis must have met the Bohan and Peter criteria for either definite or probable polymyositis or dermatomyositis criteria at some point in their lives. To meet criteria for definite or probable polymyositis, a patient must have at least 3 of the 4 the below list of symptoms. To meet criteria for definite or probable dermatomyositis, a patient must have a typical rash of dermatomyositis PLUS at least 2 of the 4 symptoms in the below list:

            1. Symmetric proximal muscle weakness
            2. Muscle biopsy evidence of myositis
            3. Increase in serum skeletal muscle enzymes
            4. Characteristic electromyographic pattern

• Overlap patients may be included if they meet the Bohan and Peter criteria.

Exclusion:

• Patients without myositis, in which myositis was not considered in the differential diagnosis.
• Patients with uncertain diagnoses.
• Patients with mental disabilities that would seriously affect the individual’s ability to complete the questionnaire or provide consent.
• Non-inflammatory inclusion body myopathy.
• Dystrophy, specify diagnosis.
• Metabolic myopathy.
• Mitochondrial myopathy.
• Drug or toxin associated myopathy.
• Infectious myopathy.
• Endocrine myopathy.
• Motor neuron diseases.
• Other neuromuscular diseases
•  Other dermatologic disease.

Contact Information

Annel Fernandez
Research Coordinator
212.774.2123
fernandeza@hss.edu