Autoimmune/Connective Tissue DiseasesNCT00341679
Studies of the Natural History and Pathogenesis of Autoimmune/Connective Tissue Diseases
An observational study of Autoimmune/Connective Tissue Diseases and Idiopathic Inflammatory Myopathies, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Autoimmune/Connective Tissue Diseases, Idiopathic Inflammatory Myopathies, Polymyositis
- How many people
- 719 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children (< 18 years of age) or adults (18 or more years of age) require a diagnosis of myositis or a related autoimmune or rheumatic disorder (by Bohan and Peter, American College of Rheumatology, or other criteria. Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease. Selected patients with other myopathies or with undefined illnesses who may have weakness, myalgias, or an elevated CK may be evaluated to establish a diagnosis. Normal volunteers will be gender- and race-matched to a subset of autoimmune subjects as controls needed for specific studies. Normal volunteers should be in good health, without a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking anti-inflammatory medicines, including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
Who may be able to join
- For the primary autoimmune and myositis study populations, children (less than 18 years of age) or adults (18 or more years of age) require a diagnosis of myositis or a related autoimmune or rheumatic disorder.
- Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease.
- Normal volunteers will be gender- and race-matched to a subset of autoimmune subjects as controls needed for specific studies.
- Normal volunteers should be in good health, without a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
- For all subjects: ability of the subject or parents/legal guardians to provide informed consent to all aspects of the study after full protocol information is provided.
- Patients enrolling in the MYOVISION national myositis patient registry were diagnosed with adult or juvenile DM, PM, IBM, or another form of myositis; resided within the United States or Canada at the time of diagnosis, and provided informed consent and completed the study questionnaires, either on paper or online. In the case of children <18 years of age, the parent or legal guardian provided informed consent and completed the study questionnaires.
Who cannot join
- medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation;
- cognitive impairment;
- inability to give informed assent or consent.
- Recognized systemic rheumatic disorder or other autoimmune disease, history of cancer or taking anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, severe trauma, infections or vaccinations within 8 weeks.
- Exclusion criteria for patients in the MYOVISION national myositis patient registry were subjects with cognitive impairment and those unable to or unwilling to give informed consent,or failing to meet the inclusion criteria of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Environmental Health Sciences (NIEHS), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
...
Read the 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 autoimmune/connective 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.
- Conditions
- Autoimmune/Connective Tissue Diseases, Idiopathic Inflammatory Myopathies, Polymyositis, Dermatomyositis
- Keywords
- Autoimmune Diseases, Polymyositis, Dermatomyositis, Idiopathic Inflammatory Myopathies, CONNECTIVE TISSUE DISEASES, Natural History, IIM
- Medical subject headings
- Connective Tissue Diseases, Myositis, Polymyositis, Dermatomyositis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Family Members | Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease | |
| IIM Patient | Adult and pediatric patients with diagnosis of myositis or a related autoimmune or rheumatic disorder (by Bohan and Peter criteria, American College of Rheumatology, or other criteria). | |
| Normal volunteers | gender and race-matched to a subset of autoimmune subjects as controls. Should be without any autoimmune disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myositis Autoantibodies
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
Measured: at the time of enrollment visit
Human leukocyte antigen
The efforts to identify candidate genes will initially include polymorphic MHC and non-MHC immune response genes such as those for HLA,cytokines and chemokines with the strongest known associations with autoimmunity
Measured: at the time of enrollment visit
Secondary outcomes (3)
Environmental Exposures
Assessment of possible selected environmental risk factors will include studies of infectious and non-infectious agents by immunologic and other approaches. Birthdates, seasonal and geographic associations with disease onset, as well as unusual clustering in the frequencies of selected phenotypes or genotypes will also be studied.
Measured: ongoing
Clinical Phenotyping of
The different phenotypes and immunologic abnormalities found in the clinicopathologic and immune response groups of the IIM suggest possible different pathogenesis and risk factors.
Measured: ongoing
Pathogenesis of the Disease
to find possible different pathogenesis of multiple immune-mediated disorders.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start13 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autoimmune/Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa G Rider, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341679
- Sponsor's protocol ID
- 999905200
- Other IDs
- 05-E-N200
- Status last verified
- 1 Jul 2026
- First submitted
- 19 Jun 2006
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team is still deciding if they would like to share individual participant data
Publications
Rider LG, Shah M, Mamyrova G, Huber AM, Rice MM, Targoff IN, Miller FW; Childhood Myositis Heterogeneity Collaborative Study Group. The myositis autoantibody phenotypes of the juvenile idiopathic inflammatory myopathies. Medicine (Baltimore). 2013 Jul;92(4):223-243. doi: 10.1097/MD.0b013e31829d08f9.
PubMed 23877355O'Hanlon TP, Carrick DM, Targoff IN, Arnett FC, Reveille JD, Carrington M, Gao X, Oddis CV, Morel PA, Malley JD, Malley K, Shamim EA, Rider LG, Chanock SJ, Foster CB, Bunch T, Blackshear PJ, Plotz PH, Love LA, Miller FW. Immunogenetic risk and protective factors for the idiopathic inflammatory myopathies: distinct HLA-A, -B, -Cw, -DRB1, and -DQA1 allelic profiles distinguish European American patients with different myositis autoantibodies. Medicine (Baltimore). 2006 Mar;85(2):111-127. doi: 10.1097/01.md.0000217525.82287.eb.
PubMed 16609350Miller FW, Chen W, O'Hanlon TP, Cooper RG, Vencovsky J, Rider LG, Danko K, Wedderburn LR, Lundberg IE, Pachman LM, Reed AM, Ytterberg SR, Padyukov L, Selva-O'Callaghan A, Radstake TR, Isenberg DA, Chinoy H, Ollier WE, Scheet P, Peng B, Lee A, Byun J, Lamb JA, Gregersen PK, Amos CI; Myositis Genetics Consortium. Genome-wide association study identifies HLA 8.1 ancestral haplotype alleles as major genetic risk factors for myositis phenotypes. Genes Immun. 2015 Oct;16(7):470-80. doi: 10.1038/gene.2015.28. Epub 2015 Aug 20.
PubMed 26291516Sherman MA, Yang Q, Gutierrez-Alamillo L, Pak K, Flegel WA, Mammen AL, Rider LG, Casciola-Rosen LA; Childhood Myositis Heterogeneity Collaborative Study Group. Clinical Features and Immunogenetic Risk Factors Associated With Additional Autoantibodies in Anti-Transcriptional Intermediary Factor 1gamma Juvenile-Onset Dermatomyositis. Arthritis Rheumatol. 2024 Apr;76(4):631-637. doi: 10.1002/art.42768. Epub 2024 Jan 30.
PubMed 38059274
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of the Natural History and Pathogenesis of Autoimmune/Connective Tissue Diseases
- ClinicalTrials.gov ID
- NCT00341679
- Acronym / sponsor ID
- 999905200
- Conditions
- Autoimmune/Connective Tissue Diseases, Idiopathic Inflammatory Myopathies, Polymyositis, Dermatomyositis
- Keywords
- Autoimmune Diseases, Polymyositis, Dermatomyositis, Idiopathic Inflammatory Myopathies, CONNECTIVE TISSUE DISEASES, Natural History, IIM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 13 Jul 2005 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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 autoimmune/connective 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family Members | – | –Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease |
| IIM Patient | – | –Adult and pediatric patients with diagnosis of myositis or a related autoimmune or rheumatic disorder (by Bohan and Peter criteria, American College of Rheumatology, or other criteria). |
| Normal volunteers | – | –gender and race-matched to a subset of autoimmune subjects as controls. Should be without any autoimmune disease. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children (< 18 years of age) or adults (18 or more years of age) require a diagnosis of myositis or a related autoimmune or rheumatic disorder (by Bohan and Peter, American College of Rheumatology, or other criteria. Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease. Selected patients with other myopathies or with undefined illnesses who may have weakness, myalgias, or an elevated CK may be evaluated to establish a diagnosis. Normal volunteers will be gender- and race-matched to a subset of autoimmune subjects as controls needed for specific studies. Normal volunteers should be in good health, without a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking anti-inflammatory medicines, including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
Key inclusion criteria (6 listed)
- For the primary autoimmune and myositis study populations, children (less than 18 years of age) or adults (18 or more years of age) require a diagnosis of myositis or a related autoimmune or rheumatic disorder.
- Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease.
- Normal volunteers will be gender- and race-matched to a subset of autoimmune subjects as controls needed for specific studies.
- Normal volunteers should be in good health, without a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
- For all subjects: ability of the subject or parents/legal guardians to provide informed consent to all aspects of the study after full protocol information is provided.
Key exclusion criteria (5 listed)
- medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation;
- cognitive impairment;
- inability to give informed assent or consent.
- Recognized systemic rheumatic disorder or other autoimmune disease, history of cancer or taking anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, severe trauma, infections or vaccinations within 8 weeks.
- Exclusion criteria for patients in the MYOVISION national myositis patient registry were subjects with cognitive impairment and those unable to or unwilling to give informed consent,or failing to meet the inclusion criteria of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myositis Autoantibodies
Time frame: at the time of enrollment visit
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
Human leukocyte antigen
Time frame: at the time of enrollment visit
The efforts to identify candidate genes will initially include polymorphic MHC and non-MHC immune response genes such as those for HLA,cytokines and chemokines with the strongest known associations with autoimmunity
3 secondary outcomes
Environmental Exposures
Time frame: ongoing
Clinical Phenotyping of
Time frame: ongoing
Pathogenesis of the Disease
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 23877355Rider LG, Shah M, Mamyrova G, Huber AM, Rice MM, Targoff IN, Miller FW; Childhood Myositis Heterogeneity Collaborative Study Group. The myositis autoantibody phenotypes of the juvenile idiopathic inflammatory myopathies. Medicine (Baltimore). 2013 Jul;92(4):223-243. doi: 10.1097/MD.0b013e31829d08f9.
- Background: PubMed 16609350O'Hanlon TP, Carrick DM, Targoff IN, Arnett FC, Reveille JD, Carrington M, Gao X, Oddis CV, Morel PA, Malley JD, Malley K, Shamim EA, Rider LG, Chanock SJ, Foster CB, Bunch T, Blackshear PJ, Plotz PH, Love LA, Miller FW. Immunogenetic risk and protective factors for the idiopathic inflammatory myopathies: distinct HLA-A, -B, -Cw, -DRB1, and -DQA1 allelic profiles distinguish European American patients with different myositis autoantibodies. Medicine (Baltimore). 2006 Mar;85(2):111-127. doi: 10.1097/01.md.0000217525.82287.eb.
- Background: PubMed 26291516Miller FW, Chen W, O'Hanlon TP, Cooper RG, Vencovsky J, Rider LG, Danko K, Wedderburn LR, Lundberg IE, Pachman LM, Reed AM, Ytterberg SR, Padyukov L, Selva-O'Callaghan A, Radstake TR, Isenberg DA, Chinoy H, Ollier WE, Scheet P, Peng B, Lee A, Byun J, Lamb JA, Gregersen PK, Amos CI; Myositis Genetics Consortium. Genome-wide association study identifies HLA 8.1 ancestral haplotype alleles as major genetic risk factors for myositis phenotypes. Genes Immun. 2015 Oct;16(7):470-80. doi: 10.1038/gene.2015.28. Epub 2015 Aug 20.
- Derived from this study: PubMed 38059274Sherman MA, Yang Q, Gutierrez-Alamillo L, Pak K, Flegel WA, Mammen AL, Rider LG, Casciola-Rosen LA; Childhood Myositis Heterogeneity Collaborative Study Group. Clinical Features and Immunogenetic Risk Factors Associated With Additional Autoantibodies in Anti-Transcriptional Intermediary Factor 1gamma Juvenile-Onset Dermatomyositis. Arthritis Rheumatol. 2024 Apr;76(4):631-637. doi: 10.1002/art.42768. Epub 2024 Jan 30.
- Individual participant dataSharing planned: Undecided. The study team is still deciding if they would like to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa G Rider, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune/Connective Tissue Diseases and Idiopathic Inflammatory Myopathies, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myositis Autoantibodies (time frame: at the time of enrollment visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341679, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.