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NCT00005571 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis
A Phase 2 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00005571 is a Phase 2 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 17 participants.
The verdict
NCT00005571, a Phase 2 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of the experimental drug h5G1.1-mAb in treating patients with dermatomyositis. This disease, which causes skin rash, muscle weakness, and sometimes various other symptoms, may be due to an immune system abnormality. Drugs currently used to treat dermatomyositis, such as prednisone and various anticancer drugs, often have serious side effects and may not work in all patients. h5G1.1-mAb is a genetically engineered antibody that blocks the activity of certain proteins involved in the immune reaction that produces inflammation. Patients age 18 years and older who have had dermatomyositis for at least 6 months and who have not improved with prednisone or other therapies, or who cannot tolerate prednisone or other therapies, may be eligible for this 12-week study. Candidates will have a history and physical examination, including blood and urine tests, throat culture, and muscle strength testing. Participants will be randomly assigned to receive either h5G1.1-mAb or placebo (an inactive substance). The drug or placebo will be given intravenously (through a thin tube inserted into a vein) once a week for five doses and then every other week for two more doses. Participants will undergo the following additional tests at various intervals during the study as follows: 1. Complete physical examination ( visit 9) 2. Blood and urine tests (various intervals) 3. Muscle strength testing, assessment of ability to perform daily tasks, and completion of questionnaire regarding functional abilities (visits 2, 6 and 9) 4. Ultrasound imaging of muscle (during certain muscle exercises) (visits 2, 6 and 9) 5. Electrocardiogram (EKG) (visits 2 and 9) 6. Throat swab (culture) (visit 6) 7. Examination and photography of skin lesions (visits 2 and 9) 8. Skin biopsy - removal of small sample of skin tissue under local anesthetic (visits 2 and 9) 9. Magnetic resonance imaging (MRI) scan of muscles (visits 2 and 9) 10. Possible muscle bio
Interventions
- DRUG h5G1.1-mAb
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2000-04 |
| Est. Completion | 2001-12 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005571
The ClinicalTrials.gov registry entry for NCT00005571 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which h5G1.1-mAb is the first listed.
NCT00005571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005571 about?
NCT00005571 is a clinical study titled "Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis". This study will evaluate the safety and effectiveness of the experimental drug h5G1.1-mAb in treating patients with dermatomyositis. This disease, which causes skin rash, muscle weakness, and sometimes various other symptoms, may be due to an immune system abnormality. Drugs currently used to treat ...
What is the current status of trial NCT00005571?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2000-04. Estimated completion is 2001-12.
What interventions are being tested in trial NCT00005571?
The interventions under investigation include: h5G1.1-mAb (DRUG).
Who is sponsoring clinical trial NCT00005571?
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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