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NCT00001265 · ClinicalTrials.gov registry record
Study and Treatment of Inflammatory Muscle Diseases
A clinical trial, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- 1,325
- Enrollment target
NCT00001265: Completed study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT00001265 is a clinical trial that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 1,325 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001265 has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- 1,325 participants
- Enrollment target
Study 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. Blood sample for genetic studies. 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. 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. 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. Manual muscle strength testing by a physiotherapist. 6. Swallowing studies using ultrasound (imaging using sound waves) and X-rays (barium swallow) to evaluate swallowing and speaking abilities. 7. Questionnaires on swallowing ability and ability to perform daily living activities 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. Chest X-rays to evaluate lung function. 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. Apheresis-colle
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,325 participants |
| Start Date | 1992-01-10 |
| Est. Completion | 2024-04-05 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT00001265 record still lists
NCT00001265 is an observational study that tracks outcomes without assigning an intervention. Its 1,325 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00001265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001265 about?
NCT00001265 is a clinical study titled "Study and Treatment of Inflammatory Muscle Diseases". 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 weakne...
What is the current status of trial NCT00001265?
This trial is currently completed. The enrollment target is 1,325 participants. The study started on 1992-01-10. Estimated completion is 2024-04-05.
Who is sponsoring clinical trial NCT00001265?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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