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NCT00341679 · ClinicalTrials.gov registry record
Studies of the Natural History and Pathogenesis of Autoimmune/Connective Tissue Diseases
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 719
- Enrollment target
NCT00341679: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00341679 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 719 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00341679 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 719 participants
- Enrollment target
Study Summary
This study will define the major genetic risk and protective factors for idiopathic inflammatory myopathies (IIM), a group of immune disorders affecting connective tissues such as muscles. It will also identify new environmental risk factors for IIM and identify immune responses in myositis and related diseases. There are many forms of IIMs, and the causes of these diseases are unknown. However, scientists suspect that they result when people with some genetic factors that predispose them-that is, put them at greater risk-are exposed to certain environmental triggers. Some of those triggers include food, drugs, biologics (such as a vaccine to prevent disease), medical devices and occupational exposures. Patients, including children under 18, who had a diagnosis of myositis, a related autoimmune disease, or a rheumatic disease, as well as their blood relatives, and control subjects who were in good health have already been recruited for this study. The evaluation consisted of one outpatient visit to the patient's doctor, who will obtain a medical history and conduct a physician examination. Patients spent 20 to 30 minutes to answer written questions. There was a blood collection of about 6 tablespoons. If there was a major change in patients' medical conditions, they were asked to return for a second outpatient evaluation to determine whether any of the blood tests or antibodies, which show an immune response, had changed. Blood samples collected will be used only for laboratory research studies. The samples have been identified by a code, and all other identifying information have been removed. During the study, researchers will explore possible environmental risk factors, including studies of infectious and non-infectious agents. They will analyze the blood for genetic markers and test for certain antibodies. Laboratory results will be evaluated as they relate to the signs, symptoms, and severity of patients' illnesses. That would help researchers to better unde
Primary Outcome
Individuals who develop autoimmune diseases are associated with self-reactive autoantibodies. The clinical course of disease in IIM appears to be more closely related to the presence of certain myositis-specific autoantibodies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2005-07-13 |
What the finished NCT00341679 record still lists
NCT00341679 is an observational study that tracks outcomes without assigning an intervention. The registered 719 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00341679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00341679 about?
NCT00341679 is a clinical study titled "Studies of the Natural History and Pathogenesis of Autoimmune/Connective Tissue Diseases". This study will define the major genetic risk and protective factors for idiopathic inflammatory myopathies (IIM), a group of immune disorders affecting connective tissues such as muscles. It will also identify new environmental risk factors for IIM and identify immune responses in myositis and rela...
What is the current status of trial NCT00341679?
This trial is currently completed. The enrollment target is 719 participants. The study started on 2005-07-13.
Who is sponsoring clinical trial NCT00341679?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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