Study and Treatment of Inflammatory Muscle Diseases

NCT00001265 | Completed

• 2 other identifiers: 91019691-AR-0196
• Study Type: observational
• Target: 1,325
• Locations: 1 country
• Sites: 1

Brief Summary

This study of inflammatory muscle diseases-polymyositis and dermatomyositis and related disorders-will examine what causes these diseases and describe the clinical features (signs and symptoms) associated with them. Inflammation and degeneration of skeletal muscles in these disorders leads to weakness and muscle wasting. The skin, lungs and other organs may also be involved. Patients 16 years of age and older with polymyositis, dermatomyositis, or a related disorder may be eligible for this study. Participants will undergo a complete history and physical examination, including routine blood and urine tests. Additional procedures for diagnosis, treatment or research may include:

1. 1.Blood sample for genetic studies.
2. 2.Muscle biopsy-removal of a tissue sample for microscopic examination. Under local anesthetic, a 1/2- to 1-inch long incision is made in the thigh or upper arm, and a small piece of muscle is removed.
3. 3.Electromyography-measurement of the electrical activity of a muscle. A needle is inserted through the skin into a muscle to record its electrical activity.
4. 4.Magnetic resonance imaging-visualization of organs or tissues, using a magnetic field and radio waves. The patient lies on a table inside a narrow cylinder (the MRI scanner) with a strong magnetic field for the scanning.
5. 5.Manual muscle strength testing by a physiotherapist.
6. 6.Swallowing studies using ultrasound (imaging using sound waves) and X-rays (barium swallow) to evaluate swallowing and speaking abilities.
7. 7.Questionnaires on swallowing ability and ability to perform daily living activities
8. 8.Pulmonary function tests-measurement of movement of air in and out of the lungs. The patient breathes into a machine to evaluate lung function.
9. 9.Chest X-rays to evaluate lung function.
10. 10.Electrocardiogram and, if necessary, Holter monitoring (measurement of the electrical activity of the heart) and echocardiogram (ultrasound imaging of the heart) to evaluate heart function.
11. 11.Apheresis-collection of white blood cells for research. Whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body through the same needle or through a second one placed in the other arm.
12. 12.MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic resonance imaging. Certain patients may undergo this experimental procedure to compare MRI findings with those of muscle biopsy. The affected muscles are identified using MRI and the biopsy incision is made. MRI is then used to guide the biopsy needle to the muscle and a small piece is removed.

Conditions

Dermatomyositis; Polymyositis

Keywords

Autoimmune Diseases; Idiopathic Inflammatory Myopathies; Dermatomyositis; Inclusion Body Myositis; Pathogenesis; Natural History; Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

• Muscle strength

  To determine its utility in differentiating different muscle diseases, in identifying early extra muscular involvement of muscle diseases, in characterizing the pattern of muscle involvement for the diseases studied, and whether it can serve as a diagnostic tool to better identify muscle inflammation and atrophy.

  End of Study

Study Arms (2)

Healthy Volunteers

Patients with no disease

Patients with muscle disease

Patients with known or suspected Idiopathic Inflammatory myopathies (IIM)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers and patients with known or suspected Idiopathic Inflammatory myopathies (IIM)

You may qualify if:

• In summary,
• The pregnant body possesses a unique hormonal and immunological environment. Similarly, it metabolizes medications in a manner different from non-pregnant women, let alone men. Hence, there is no reasonable path towards generating important biomedical knowledge other than to include pregnant women in this protocol.
• Participation of NIH Staff or family members of study team members
• NIH staff and family members of study team members may be enrolled in this study as this population meets the study entry criteria. Neither participation nor refusal to participate as a subject in the research will have an effect, either beneficial or adverse, on the participant s employment or position at NIH.
• Every effort will be made to protect participant information, but such information may be available in medical records and may be available to authorized users outside of the study team in both an identifiable an unidentifiable manner.
• The NIH Information Sheet on NIH Staff Research Participation will be made available. Please see section for consent of NIH Staff.

You may not qualify if:

• Children (age less than 16 years) are excluded
• Subjects or their legal guardians who are unable or unwilling to give informed consent/assent.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Dermatomyositis; Polymyositis; Autoimmune Diseases; Myositis; Myositis, Inclusion Body; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Immune System Diseases

Study Officials

• Andrew L Mammen, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: January 10, 1992
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (1)