NCT00341679

Studies of the Natural History and Pathogenesis of Autoimmune/Connective Tissue Diseases

Completed Last updated 17 February 2026

What this trial tests

trial in Autoimmune/Connective Tissue Diseases in 719 participants. Completed.

Timeline

13 July 2005

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	719
Start date	13 July 2005
Sites	1 location across United States

Conditions studied

• Autoimmune/Connective Tissue Diseases — all drugs for Autoimmune/Connective Tissue Diseases →
• Idiopathic Inflammatory Myopathies — all drugs for Idiopathic Inflammatory Myopathies →
• Polymyositis — all drugs for Polymyositis →
• Dermatomyositis — all drugs for Dermatomyositis →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

2 and older, any sex, with Autoimmune/Connective Tissue Diseases or Idiopathic Inflammatory Myopathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 understand patterns of the diseases and the outcomes for patients.

This study will not have a direct benefit for patients. However, results from the study can be made available to patients' doctors for use in appropriate care. Also, it is hoped that information gained can help other people in the future.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Myositis-Associated Autoantibodies in Patients With Juvenile Myositis Are Associated With Refractory Disease and Mortality.
   Sherman MA, Noroozi Farhadi P, Pak K, Trieu EP, et al · · 2024 · cited 6× · PMID 38272842 · DOI 10.1002/art.42813
2. Clinical Features and Immunogenetic Risk Factors Associated With Additional Autoantibodies in Anti-Transcriptional Intermediary Factor 1γ Juvenile-Onset Dermatomyositis.
   Sherman MA, Yang Q, Gutierrez-Alamillo L, Pak K, et al · · 2024 · cited 6× · PMID 38059274 · DOI 10.1002/art.42768
3. Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles.
   Kim H, Saygin D, Douglas C, Wilkerson J, et al · · 2023 · cited 2× · PMID 36929918 · DOI 10.1093/rheumatology/kead111
4. Factors associated with interstitial lung disease among patients with idiopathic inflammatory myopathies.
   Wilkerson JC, Miller FW, Bridge MF, Larson GJ, et al · · 2026 · cited 1× · PMID 41317376 · DOI 10.1093/rheumatology/keaf625