Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341679
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-06-19
Brief Title:
Studies of the Natural History and Pathogenesis of AutoimmuneConnective Tissue Diseases
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of the Natural History and Pathogenesis of AutoimmuneConnective Tissue Diseases
Status:
COMPLETED
Status Verified Date:
2024-07-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 patients 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
Detailed Description:
Individuals who develop chronic harmful inflammation in association with self-reactive autoantibodies or T cells are said to have autoimmune diseases The causes of these diseases are unknown but they are thought to occur in genetically susceptible individuals after exposure to selected environmental agents There are many forms of these diseases but we have been focusing on one of the rarest and most poorly-studied group of autoimmune disorders known as the Idiopathic Inflammatory Myopathies IIM This heterogeneous group of diseases includes polymyositis dermatomyositis and related disorders This is a natural history protocol designed to continue our study of these diseases and begin the evaluation of related connective tissue disorders associated with environmental exposures We plan to further delineate important groups of patients and familial cases and obtain useful material for further investigations of the clinical presentations etiology pathogenesis and immunologic abnormalities of autoimmuneconnective tissue diseases Clinical data and patient blood urine and tissue specimens have been collected by referring physicians and sent to us The blood samples have been separated into cells and plasma frozen and then placed into cell and plasma banks Often the diagnosis of an IIM can be confused with other illness such as adult-onset dystrophies and therefore we have also included patients with other illnesses who are referred with a preliminary diagnosis of an IIM or an unknown myopathy including patients with other autoimmune diseases In order to understand more fully the genetic risk factors for these diseases family members of selected patients who have several blood relatives with autoimmune or connective tissue diseases will also be studied In summary this natural history protocol will attempt through a series of hypothesis-testing and hypothesis-generating studies to obtain new information regarding the clinical presentation risk and protective factors pathogeneses and prognostic features for myositis and related conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-E-N200 | None | None | None |