Rheumatoid ArthritisNCT00055055
Study of Families With Twins or Siblings Discordant for Rheumatic Disorders
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by National Institute of Environmental Health Sciences (NIEHS) at 3 sites in United States.
Trial summary
This study will examine families in which one sibling of a sibling pair, or twin pair, has developed a systemic rheumatic disease and one has not, to see if and how the two differ in the following: Blood cell metabolism; Types of cells in the blood; Environmental exposures or genetic factors that might explain why one… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
- How many people
- 1,056 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2003to 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: 1- Proband who have documented evidence that he/she meets criteria for adult and juvenile forms of systemic rheumatic disorders defined here as rheumatoid arthritis (RA), systemic lupus 2- Twin pair of the proband who does not meet criteria for one of the rheumatic diseases and is willing to give consent and enroll in the study 3- Sibling of the same biological parents, same gender, within 5 years of age of the proband who does not meet criteria for one of the rheumatic diseases and is willing to give consent and enroll in the study 4- Biological mother or father of the proband who is willing to enroll in the study 5- A healthy individual who has not used any anti-inflammatory medications, has not had an infectious disease(persistent or chronic infection, history of M. tuberculosis, HIV or active infection), or experienced severe trauma within 8 weeks of enrollment, doesn't have a first degree relatives with RA, SLE, SSc or IIM and is willing to participate in the study
Who may be able to join
- The minimum inclusion criteria needed for enrollment are a twin pair or sibling pair, as defined by an eligible proband and his/her eligible twin or sibling, willing and able to give informed consent, to enroll in the study, to complete the questionnaires and to donate blood and urine samples (in case of children, parent/legal guardian must also be willing and able to provide informed consent).
- Proband inclusion criteria:
- Children (< 18 years of age) or adults (18 or more years of age) require a diagnosis of a systemic rheumatic disorder (by American College of Rheumatology (ACR) or other criteria for the adult or juvenile forms of RA, SLE, SSc, or IIM (per (92;93)). Regarding the childhood-onset diseases: JRA will be defined by age of onset <17 years of age; for other diseases age of onset will be < 18 years. Probands will be diagnosed within 5 years of enrollment in the study, with at least one twin or other sibling of the same gender within 5 years of age and without a recognized systemic rheumatic disorder or other autoimmune disease available for study.
- Twin-sibling inclusion criteria:
- -Children or adults who are twins or other siblings of a proband sharing the same biological parents, but without a recognized systemic rheumatic or autoimmune disorder, of the same gender and within 5 years of age of the proband. If monozygotic twins are enrolled from a family, another unaffected non-twin sibling sharing the same biological parents will be enrolled for each proband if available to allow for log-linear genetic analyses. All probands and unaffected siblings need to be at least one year of age at the time of autoimmune disease diagnosis. In the case of triplets or greater multiples, all such siblings are eligible for enrollment.
- Parent inclusion criteria:
Show all 12Show fewer
- -Individuals who are the genetic father and mother of the proband and twin-sib. Both parents will be enrolled whenever possible.
- Healthy volunteer inclusion criteria:
- Healthy controls, recruited in part via the NIH Healthy Volunteers program, and as reasonably as possible, matched to a subset of probands based on age (within 5 years), gender, and race (when feasible). Healthy volunteers should be in good health, without
- a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking antiinflammatory 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.
- Should a participant enroll at a time when his/her twin/sibling is willing and able to give informed consent, but his/her twin/sibling never enrolls (eg. Due to no longer being willing or able to give informed consent), the enrolled participant will remain in the study and his/her data will be used in the analyses not pertinent to his/her twin/sibling. Data analysis will also occur in this manner should the enrolled participant s sibling enroll, but never send in blood samples and/or questionnaires.
Who cannot join
- severe trauma or vaccinations within 8 weeks of enrollment;
- Still s disease/systemic-onset or pauciarticular JRA;
- 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.
- Not sharing the same biological parents (being half-brothers or half-sisters). Known criteria for systemic rheumatic disease or autoimmune disease (for example: RA/JRA, SLE/JSLE, SSc/JSSc, IIM/JIIM, Type 1 diabetes, Psoriasis, Still s disease/systemic-onset or pauciarticular JRA, Celiac sprue, Autoimmune thyroid disease, Idiopathic Thrombocytopenia Purpura, Multiple sclerosis, Myasthenia gravis, Systemic vasculitis or Vitiligo).
- 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 or vaccinations within 8 weeks.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
University of Wisconsin
Madison, Wisconsin, 53792
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina
About this study
Official title: Pathogenic Studies In Families With Twins Or Siblings Discordant For Systemic Rheumatic Disorders
This study will examine families in which one sibling of a sibling pair, or twin pair, has developed a systemic rheumatic disease and one has not, to see if and how the two differ in the following:
- Blood cell metabolism;
- Types of cells in the blood;
- Environmental exposures or genetic factors that might explain why one developed disease and the other did not.
Read more
Families in which one sibling has developed a systemic rheumatic disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the other has not, are eligible for this study. The siblings may or may not be twins, but must be of the same gender and be within a 5-year age difference. Biological parents, or, in some cases, children, will also be included in the study. Normal, healthy volunteers will serve as control subjects.
Participants will undergo some or all of the following tests and procedures:
- Medical history and physical examination. Participants will also be asked permission to obtain medical records for review.
- Questionnaires about environmental exposures at work, at home, and elsewhere. Probands (participants with rheumatic disease) and their healthy siblings will also answer questions about infections, vaccinations, medications or dietary supplements, sun exposure, and stressful events during the year before disease diagnosis in the affected sibling.
- Blood and urine collection for the following tests:
- Routine blood chemistries and other studies to rule out certain diseases or medical problems;
- Evidence of past toxic exposures and certain infections;
- Presence of cells from the mother in the child s blood and vice versa. (Recent studies suggest that during pregnancy or delivery, cells from the mother and baby may be exchanged and circulate in the body for many years, possibly causing problems);
- In twin or sibling pairs, presence of certain genes that may be more common in patients with systematic rheumatic diseases as compared with their unaffected siblings and normal volunteers;
- In identical twins, comparison of their blood cell metabolism to see if and how the metabolism differs in people with rheumatic disease.
Participants may be asked for permission to have some of their blood and urine samples stored and to obtain previously collected blood or tissue biopsy specimens that are no longer needed for clinical care, for research purposes. They may also be asked to give additional blood or urine samples.
Participants will be followed every year for 5 years (either in person or by questionnaire) to evaluate any changes in their condition. The final 5-year evaluation will repeat some of the questionnaires and procedures described above.
...
Read the detailed description
Most autoimmune diseases are thought to develop as a result of chronic immune activation and dysregulation after selected environmental exposures in genetically susceptible individuals. Current evidence suggests that the adult and juvenile forms of systemic rheumatic disorders -- defined here as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM) -- share many common clinical manifestations, immune responses, genetic, hormonal and environmental risk factors, and possible pathogeneses. Conversely, other studies imply that each rheumatic disease, as currently defined, may be composed of more homogeneous subgroups, known as elemental disorders, with different pathogeneses. This protocol will explore pathogenic mechanisms for systemic rheumatic disorders and possible elemental disorders through the evaluation of families with monozygotic or dizygotic twins or other siblings discordant for systemic rheumatic disorders (twin-sib pairs). Parents and healthy volunteers will also be evaluated as needed for the experimental designs of each portion of the protocol. A clinical evaluation, using standardized physician and patient clinical and environmental exposure questionnaires, and specimen collections from 400 twin-sib pairs discordant for systemic rheumatic disorders will be performed to confirm diagnoses, document medical histories and assess possible risk factors implicated in the development of autoimmunity. This study will evaluate children, who will make up 25-50% of the twin-sib pairs, and adults in similar ways to attempt to understand possible similarities and differences in pathogeneses of systemic rheumatic disorders based upon age of onset. Hypothesis-testing studies will assess differences in peripheral blood cell gene activation/suppression, levels and types of microchimerism between affected and unaffected individuals, selected genetic risk factors for these disorders and occupational and hormonal exposures hypothesized to be potential risk factors for these diseases. Exploratory studies will be conducted to begin to assess other environmental risk factors for systemic rheumatic disorders and to better understand associations among phenotypes and genotypes. Biologic specimens -- including blood, urine, and other clinical specimens or biopsies no longer necessary for clinical care -- will be collected for directed biomarker assays and the development of repositories for future research.
- Keywords
- Autoimmunity Pathogenesis, Microarray Analyses, Microchimerism, Natural History
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Myositis
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 |
|---|---|---|
| Healthy Volunteers | A healthy individual who has not used any NSAIDS, with no infectious disease, or severe trauma within 8 weeks of enrollment, doesn't have a first degree relatives with RA, SLE, SSc or IIM | |
| Parent of Proband | Biological mother or father of the proband who is willing to enroll in the study | |
| Primary Unaffected Dizygous Twin | Dizygotic twin pair of the proband who does not meet criteria for one of the rheumatic diseases | |
| Primary Unaffected Monozygous Twin | Monozygotic twin pair of the proband who does not meet criteria for one of the rheumatic diseases | |
| Primary Unaffected Non-twin Sibling | Sibling of the same biological parents, same gender, within 5 years of age of the proband who does not meet criteria for one of the rheumatic diseases | |
| Proband | Proband should have documented evidence that he/she meets criteria for adult and juvenile forms of systemic rheumatic disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assesment Questionnaire
Evaluate core set disease activity, damage and quality of life measures in adult and juvenile myositis patients
Measured: At enrollment and each study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2003 (estimated)
- Study start21 Apr 2003
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 Rheumatoid ArthritisStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,056 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
- NCT00055055
- Sponsor's protocol ID
- 030099
- Other IDs
- 03-E-0099
- Status last verified
- 8 Sep 2026
- First submitted
- 15 Feb 2003
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan for IPD availability, we are still deciding
Publications
Gan L, O'Hanlon TP, Gordon AS, Rider LG, Miller FW, Burbelo PD. Twins discordant for myositis and systemic lupus erythematosus show markedly enriched autoantibodies in the affected twin supporting environmental influences in pathogenesis. BMC Musculoskelet Disord. 2014 Mar 6;15:67. doi: 10.1186/1471-2474-15-67.
PubMed 24602337O'Hanlon TP, Rider LG, Gan L, Fannin R, Paules RS, Umbach DM, Weinberg CR, Shah RR, Mav D, Gourley MF, Miller FW. Gene expression profiles from discordant monozygotic twins suggest that molecular pathways are shared among multiple systemic autoimmune diseases. Arthritis Res Ther. 2011 Apr 26;13(2):R69. doi: 10.1186/ar3330.
PubMed 21521520Javierre BM, Fernandez AF, Richter J, Al-Shahrour F, Martin-Subero JI, Rodriguez-Ubreva J, Berdasco M, Fraga MF, O'Hanlon TP, Rider LG, Jacinto FV, Lopez-Longo FJ, Dopazo J, Forn M, Peinado MA, Carreno L, Sawalha AH, Harley JB, Siebert R, Esteller M, Miller FW, Ballestar E. Changes in the pattern of DNA methylation associate with twin discordance in systemic lupus erythematosus. Genome Res. 2010 Feb;20(2):170-9. doi: 10.1101/gr.100289.109. Epub 2009 Dec 22.
PubMed 20028698Sherman 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenic Studies In Families With Twins Or Siblings Discordant For Systemic Rheumatic Disorders
- ClinicalTrials.gov ID
- NCT00055055
- Acronym / sponsor ID
- 030099
- Keywords
- Autoimmunity Pathogenesis, Microarray Analyses, Microchimerism, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 21 Apr 2003 (actual)
- First posted
- 17 Feb 2003 (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 examine families in which one sibling of a sibling pair, or twin pair, has developed a systemic rheumatic disease and one has not, to see if and how the two differ in the following:
- Blood cell metabolism;
- Types of cells in the blood;
- Environmental exposures or genetic factors that might explain why one developed disease and the other did not.
Families in which one sibling has developed a systemic rheumatic disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the other has not, are eligible for this study. The siblings may or may not be twins, but must be of the same gender and be within a 5-year age difference. Biological parents, or, in some cases, children, will also be included in the study. Normal, healthy volunteers will serve as control subjects.
Participants will undergo some or all of the following tests and procedures:
- Medical history and physical examination. Participants will also be asked permission to obtain medical records for review.
- Questionnaires about environmental exposures at work, at home, and elsewhere. Probands (participants with rheumatic disease) and their healthy siblings will also answer questions about infections, vaccinations, medications or dietary supplements, sun exposure, and stressful events during the year before disease diagnosis in the affected sibling.
- Blood and urine collection for the following tests:
- Routine blood chemistries and other studies to rule out certain diseases or medical problems;
- Evidence of past toxic exposures and certain infections;
- Presence of cells from the mother in the child s blood and vice versa. (Recent studies suggest that during pregnancy or delivery, cells from the mother and baby may be exchanged and circulate in the body for many years, possibly causing problems);
- In twin or sibling pairs, presence of certain genes that may be more common in patients with systematic rheumatic diseases as compared with their unaffected siblings and normal volunteers;
- In identical twins, comparison of their blood cell metabolism to see if and how the metabolism differs in people with rheumatic disease.
Participants may be asked for permission to have some of their blood and urine samples stored and to obtain previously collected blood or tissue biopsy specimens that are no longer needed for clinical care, for research purposes. They may also be asked to give additional blood or urine samples.
Participants will be followed every year for 5 years (either in person or by questionnaire) to evaluate any changes in their condition. The final 5-year evaluation will repeat some of the questionnaires and procedures described above.
...
Detailed description
Most autoimmune diseases are thought to develop as a result of chronic immune activation and dysregulation after selected environmental exposures in genetically susceptible individuals. Current evidence suggests that the adult and juvenile forms of systemic rheumatic disorders -- defined here as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM) -- share many common clinical manifestations, immune responses, genetic, hormonal and environmental risk factors, and possible pathogeneses. Conversely, other studies imply that each rheumatic disease, as currently defined, may be composed of more homogeneous subgroups, known as elemental disorders, with different pathogeneses. This protocol will explore pathogenic mechanisms for systemic rheumatic disorders and possible elemental disorders through the evaluation of families with monozygotic or dizygotic twins or other siblings discordant for systemic rheumatic disorders (twin-sib pairs). Parents and healthy volunteers will also be evaluated as needed for the experimental designs of each portion of the protocol. A clinical evaluation, using standardized physician and patient clinical and environmental exposure questionnaires, and specimen collections from 400 twin-sib pairs discordant for systemic rheumatic disorders will be performed to confirm diagnoses, document medical histories and assess possible risk factors implicated in the development of autoimmunity. This study will evaluate children, who will make up 25-50% of the twin-sib pairs, and adults in similar ways to attempt to understand possible similarities and differences in pathogeneses of systemic rheumatic disorders based upon age of onset. Hypothesis-testing studies will assess differences in peripheral blood cell gene activation/suppression, levels and types of microchimerism between affected and unaffected individuals, selected genetic risk factors for these disorders and occupational and hormonal exposures hypothesized to be potential risk factors for these diseases. Exploratory studies will be conducted to begin to assess other environmental risk factors for systemic rheumatic disorders and to better understand associations among phenotypes and genotypes. Biologic specimens -- including blood, urine, and other clinical specimens or biopsies no longer necessary for clinical care -- will be collected for directed biomarker assays and the development of repositories for future research.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –A healthy individual who has not used any NSAIDS, with no infectious disease, or severe trauma within 8 weeks of enrollment, doesn't have a first degree relatives with RA, SLE, SSc or IIM |
| Parent of Proband | – | –Biological mother or father of the proband who is willing to enroll in the study |
| Primary Unaffected Dizygous Twin | – | –Dizygotic twin pair of the proband who does not meet criteria for one of the rheumatic diseases |
| Primary Unaffected Monozygous Twin | – | –Monozygotic twin pair of the proband who does not meet criteria for one of the rheumatic diseases |
| Primary Unaffected Non-twin Sibling | – | –Sibling of the same biological parents, same gender, within 5 years of age of the proband who does not meet criteria for one of the rheumatic diseases |
| Proband | – | –Proband should have documented evidence that he/she meets criteria for adult and juvenile forms of systemic rheumatic disorders |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1- Proband who have documented evidence that he/she meets criteria for adult and juvenile forms of systemic rheumatic disorders defined here as rheumatoid arthritis (RA), systemic lupus 2- Twin pair of the proband who does not meet criteria for one of the rheumatic diseases and is willing to give consent and enroll in the study 3- Sibling of the same biological parents, same gender, within 5 years of age of the proband who does not meet criteria for one of the rheumatic diseases and is willing to give consent and enroll in the study 4- Biological mother or father of the proband who is willing to enroll in the study 5- A healthy individual who has not used any anti-inflammatory medications, has not had an infectious disease(persistent or chronic infection, history of M. tuberculosis, HIV or active infection), or experienced severe trauma within 8 weeks of enrollment, doesn't have a first degree relatives with RA, SLE, SSc or IIM and is willing to participate in the study
Key inclusion criteria (12 listed)
- The minimum inclusion criteria needed for enrollment are a twin pair or sibling pair, as defined by an eligible proband and his/her eligible twin or sibling, willing and able to give informed consent, to enroll in the study, to complete the questionnaires and to donate blood and urine samples (in case of children, parent/legal guardian must also be willing and able to provide informed consent).
- Children (< 18 years of age) or adults (18 or more years of age) require a diagnosis of a systemic rheumatic disorder (by American College of Rheumatology (ACR) or other criteria for the adult or juvenile forms of RA, SLE, SSc, or IIM (per (92;93)). Regarding the childhood-onset diseases: JRA will be defined by age of onset <17 years of age; for other diseases age of onset will be < 18 years. Probands will be diagnosed within 5 years of enrollment in the study, with at least one twin or other sibling of the same gender within 5 years of age and without a recognized systemic rheumatic disorder or other autoimmune disease available for study.
- -Children or adults who are twins or other siblings of a proband sharing the same biological parents, but without a recognized systemic rheumatic or autoimmune disorder, of the same gender and within 5 years of age of the proband. If monozygotic twins are enrolled from a family, another unaffected non-twin sibling sharing the same biological parents will be enrolled for each proband if available to allow for log-linear genetic analyses. All probands and unaffected siblings need to be at least one year of age at the time of autoimmune disease diagnosis. In the case of triplets or greater multiples, all such siblings are eligible for enrollment.
- -Individuals who are the genetic father and mother of the proband and twin-sib. Both parents will be enrolled whenever possible.
- Healthy controls, recruited in part via the NIH Healthy Volunteers program, and as reasonably as possible, matched to a subset of probands based on age (within 5 years), gender, and race (when feasible). Healthy volunteers should be in good health, without
Key exclusion criteria (7 listed)
- severe trauma or vaccinations within 8 weeks of enrollment;
- Still s disease/systemic-onset or pauciarticular JRA;
- 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.
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
Physician Global Assesment Questionnaire
Time frame: At enrollment and each study
Evaluate core set disease activity, damage and quality of life measures in adult and juvenile myositis patients
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 27 Oct 2026.
- Background: PubMed 24602337Gan L, O'Hanlon TP, Gordon AS, Rider LG, Miller FW, Burbelo PD. Twins discordant for myositis and systemic lupus erythematosus show markedly enriched autoantibodies in the affected twin supporting environmental influences in pathogenesis. BMC Musculoskelet Disord. 2014 Mar 6;15:67. doi: 10.1186/1471-2474-15-67.
- Background: PubMed 21521520O'Hanlon TP, Rider LG, Gan L, Fannin R, Paules RS, Umbach DM, Weinberg CR, Shah RR, Mav D, Gourley MF, Miller FW. Gene expression profiles from discordant monozygotic twins suggest that molecular pathways are shared among multiple systemic autoimmune diseases. Arthritis Res Ther. 2011 Apr 26;13(2):R69. doi: 10.1186/ar3330.
- Background: PubMed 20028698Javierre BM, Fernandez AF, Richter J, Al-Shahrour F, Martin-Subero JI, Rodriguez-Ubreva J, Berdasco M, Fraga MF, O'Hanlon TP, Rider LG, Jacinto FV, Lopez-Longo FJ, Dopazo J, Forn M, Peinado MA, Carreno L, Sawalha AH, Harley JB, Siebert R, Esteller M, Miller FW, Ballestar E. Changes in the pattern of DNA methylation associate with twin discordance in systemic lupus erythematosus. Genome Res. 2010 Feb;20(2):170-9. doi: 10.1101/gr.100289.109. Epub 2009 Dec 22.
- 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan for IPD availability, we are still deciding
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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)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by National Institute of Environmental Health Sciences (NIEHS) at 3 sites 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 12 inclusion and 7 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Physician Global Assesment Questionnaire (time frame: At enrollment and each study). 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 NCT00055055, 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 27 Oct 2026.