Juvenile Rheumatoid ArthritisNCT00090571
Juvenile Rheumatoid Arthritis Research Registry
An observational study of Juvenile Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
Juvenile rheumatoid arthritis (JRA) is the most common chronic inflammatory disease in children, and may be related to genetics. Having two siblings who both have JRA in one family is rare. The purpose of this registry is to collect patient information and blood samples from qualifying JRA siblings and their families. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Juvenile Rheumatoid Arthritis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1994to Sep 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: siblings affected with JIA
Who may be able to join
- At least two members of a family diagnosed with juvenile rheumatoid arthritis (JRA)
- Informed consent from the family indicating willingness to participate in the registry
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: Research Registry for Juvenile Arthritis
Juvenile rheumatoid arthritis (JRA) is the most common chronic inflammatory disease in children, and may be related to genetics. Having two siblings who both have JRA in one family is rare. The purpose of this registry is to collect patient information and blood samples from qualifying JRA siblings and their families. The goal of the registry is to further understanding of JRA as related to genetics.
Read the detailed description
JRA is the most common chronic inflammatory pediatric rheumatic disease. JRA may be related to a complex genetic trait. It is rare to have two or more affected siblings, or sibpairs, within one family. The JRA ASP (Affected Sibpair) Registry is a nationwide effort and will collect information and blood samples from JRA sibpairs and their families. Unaffected family members (e.g., mother, father, and unaffected children) are also invited to participate.
Patients and their families may enroll in the registry in one of two ways: patients may contact the registry directly, or they may be referred to the registry through their physician. Once the family has qualified to join the registry, the family will be asked to complete a questionnaire on the medical history of their JRA-affected members. Physicians of the JRA-affected members will be asked to complete questionnaires about their patients' conditions. Family members will also be invited to provide a one-time blood sample. Information collected through the registry will help researchers identify genes involved in JRA susceptibility.
- Conditions
- Juvenile Rheumatoid Arthritis
- Keywords
- JRA ASPs, Genomics
- Medical subject headings
- Arthritis, Juvenile
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 |
|---|---|---|
| Sib Pairs | Two or more biological siblings affected with JIA. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2004 (estimated)
- Study startOct 1994
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Juvenile 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- David N. Glass, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090571
- Sponsor's protocol ID
- NIAMS-102
- Other IDs
- N01AR42272-8-0-1, NIAMS-102;N01-04-03
- Status last verified
- Sep 2022
- First submitted
- 27 Aug 2004
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Moroldo MB, Chaudhari M, Shear E, Thompson SD, Glass DN, Giannini EH. Juvenile rheumatoid arthritis affected sibpairs: extent of clinical phenotype concordance. Arthritis Rheum. 2004 Jun;50(6):1928-34. doi: 10.1002/art.20292.
PubMed 15188369Barnes MG, Aronow BJ, Luyrink LK, Moroldo MB, Pavlidis P, Passo MH, Grom AA, Hirsch R, Giannini EH, Colbert RA, Glass DN, Thompson SD. Gene expression in juvenile arthritis and spondyloarthropathy: pro-angiogenic ELR+ chemokine genes relate to course of arthritis. Rheumatology (Oxford). 2004 Aug;43(8):973-9. doi: 10.1093/rheumatology/keh224. Epub 2004 May 18.
PubMed 15150433Ogilvie EM, Fife MS, Thompson SD, Twine N, Tsoras M, Moroldo M, Fisher SA, Lewis CM, Prieur AM, Glass DN, Woo P. The -174G allele of the interleukin-6 gene confers susceptibility to systemic arthritis in children: a multicenter study using simplex and multiplex juvenile idiopathic arthritis families. Arthritis Rheum. 2003 Nov;48(11):3202-6. doi: 10.1002/art.11300.
PubMed 14613283Moroldo MB, Tague BL, Shear ES, Glass DN, Giannini EH. Juvenile rheumatoid arthritis in affected sibpairs. Arthritis Rheum. 1997 Nov;40(11):1962-6. doi: 10.1002/art.1780401107.
PubMed 9365084Prahalad S, Shear ES, Thompson SD, Giannini EH, Glass DN. Increased prevalence of familial autoimmunity in simplex and multiplex families with juvenile rheumatoid arthritis. Arthritis Rheum. 2002 Jul;46(7):1851-6. doi: 10.1002/art.10370.
PubMed 12124869Prahalad S, Ryan MH, Shear ES, Thompson SD, Glass DN, Giannini EH. Twins concordant for juvenile rheumatoid arthritis. Arthritis Rheum. 2000 Nov;43(11):2611-2. doi: 10.1002/1529-0131(200011)43:113.0.CO;2-T. No abstract available.
PubMed 11083290Prahalad S, Ryan MH, Shear ES, Thompson SD, Giannini EH, Glass DN. Juvenile rheumatoid arthritis: linkage to HLA demonstrated by allele sharing in affected sibpairs. Arthritis Rheum. 2000 Oct;43(10):2335-8. doi: 10.1002/1529-0131(200010)43:103.0.CO;2-W.
PubMed 11037894Hinks A, Ke X, Barton A, Eyre S, Bowes J, Worthington J, Thompson SD, Langefeld CD, Glass DN, Thomson W; UK Rheumatoid Arthritis Genetics Consortium; British Society of Paediatric and Adolescent Rheumatology Study Group. Association of the IL2RA/CD25 gene with juvenile idiopathic arthritis. Arthritis Rheum. 2009 Jan;60(1):251-7. doi: 10.1002/art.24187.
PubMed 19116909Zeft A, Shear ES, Thompson SD, Glass DN, Prahalad S. Familial autoimmunity: maternal parent-of-origin effect in juvenile idiopathic arthritis. Clin Rheumatol. 2008 Feb;27(2):241-4. doi: 10.1007/s10067-007-0778-8. Epub 2007 Nov 10.
PubMed 17994193Prahalad S, Bohnsack JF, Whiting A, Clifford B, Jorde LB, Guthery SL, Thompson SD, Glass DN, Bamshad MJ. Lack of association of functional CTLA4 polymorphisms with juvenile idiopathic arthritis. Arthritis Rheum. 2008 Jul;58(7):2147-52. doi: 10.1002/art.23602.
PubMed 18576317Prahalad S, Bohnsack JF, Jorde LB, Whiting A, Clifford B, Dunn D, Weiss R, Moroldo M, Thompson SD, Glass DN, Bamshad MJ. Association of two functional polymorphisms in the CCR5 gene with juvenile rheumatoid arthritis. Genes Immun. 2006 Sep;7(6):468-75. doi: 10.1038/sj.gene.6364317. Epub 2006 Jun 15.
PubMed 16775617Phelan JD, Thompson SD. Genomic progress in pediatric arthritis: recent work and future goals. Curr Opin Rheumatol. 2006 Sep;18(5):482-9. doi: 10.1097/01.bor.0000240359.30303.e4.
PubMed 16896287Phelan JD, Thompson SD, Glass DN. Susceptibility to JRA/JIA: complementing general autoimmune and arthritis traits. Genes Immun. 2006 Jan;7(1):1-10. doi: 10.1038/sj.gene.6364273.
PubMed 16435022Ferucci ED, Majka DS, Parrish LA, Moroldo MB, Ryan M, Passo M, Thompson SD, Deane KD, Rewers M, Arend WP, Glass DN, Norris JM, Holers VM. Antibodies against cyclic citrullinated peptide are associated with HLA-DR4 in simplex and multiplex polyarticular-onset juvenile rheumatoid arthritis. Arthritis Rheum. 2005 Jan;52(1):239-46. doi: 10.1002/art.20773.
PubMed 15641089Bukulmez H, Fife M, Tsoras M, Thompson SD, Twine NA, Woo P, Olson JM, Elston RC, Glass DN, Colbert RA. Tapasin gene polymorphism in systemic onset juvenile rheumatoid arthritis: a family-based case-control study. Arthritis Res Ther. 2005;7(2):R285-90. doi: 10.1186/ar1480. Epub 2005 Jan 11.
PubMed 15743475
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Registry for Juvenile Arthritis
- ClinicalTrials.gov ID
- NCT00090571
- Acronym / sponsor ID
- NIAMS-102
- Conditions
- Juvenile Rheumatoid Arthritis
- Keywords
- JRA ASPs, Genomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Oct 1994
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Aug 2004 (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.
Juvenile rheumatoid arthritis (JRA) is the most common chronic inflammatory disease in children, and may be related to genetics. Having two siblings who both have JRA in one family is rare. The purpose of this registry is to collect patient information and blood samples from qualifying JRA siblings and their families. The goal of the registry is to further understanding of JRA as related to genetics.
Detailed description
JRA is the most common chronic inflammatory pediatric rheumatic disease. JRA may be related to a complex genetic trait. It is rare to have two or more affected siblings, or sibpairs, within one family. The JRA ASP (Affected Sibpair) Registry is a nationwide effort and will collect information and blood samples from JRA sibpairs and their families. Unaffected family members (e.g., mother, father, and unaffected children) are also invited to participate.
Patients and their families may enroll in the registry in one of two ways: patients may contact the registry directly, or they may be referred to the registry through their physician. Once the family has qualified to join the registry, the family will be asked to complete a questionnaire on the medical history of their JRA-affected members. Physicians of the JRA-affected members will be asked to complete questionnaires about their patients' conditions. Family members will also be invited to provide a one-time blood sample. Information collected through the registry will help researchers identify genes involved in JRA susceptibility.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sib Pairs | – | –Two or more biological siblings affected with JIA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- siblings affected with JIA
Key inclusion criteria (2 listed)
- At least two members of a family diagnosed with juvenile rheumatoid arthritis (JRA)
- Informed consent from the family indicating willingness to participate in the registry
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 28 Sep 2022.
- Background: PubMed 15188369Moroldo MB, Chaudhari M, Shear E, Thompson SD, Glass DN, Giannini EH. Juvenile rheumatoid arthritis affected sibpairs: extent of clinical phenotype concordance. Arthritis Rheum. 2004 Jun;50(6):1928-34. doi: 10.1002/art.20292.
- Background: PubMed 15150433Barnes MG, Aronow BJ, Luyrink LK, Moroldo MB, Pavlidis P, Passo MH, Grom AA, Hirsch R, Giannini EH, Colbert RA, Glass DN, Thompson SD. Gene expression in juvenile arthritis and spondyloarthropathy: pro-angiogenic ELR+ chemokine genes relate to course of arthritis. Rheumatology (Oxford). 2004 Aug;43(8):973-9. doi: 10.1093/rheumatology/keh224. Epub 2004 May 18.
- Background: PubMed 14613283Ogilvie EM, Fife MS, Thompson SD, Twine N, Tsoras M, Moroldo M, Fisher SA, Lewis CM, Prieur AM, Glass DN, Woo P. The -174G allele of the interleukin-6 gene confers susceptibility to systemic arthritis in children: a multicenter study using simplex and multiplex juvenile idiopathic arthritis families. Arthritis Rheum. 2003 Nov;48(11):3202-6. doi: 10.1002/art.11300.
- Background: PubMed 9365084Moroldo MB, Tague BL, Shear ES, Glass DN, Giannini EH. Juvenile rheumatoid arthritis in affected sibpairs. Arthritis Rheum. 1997 Nov;40(11):1962-6. doi: 10.1002/art.1780401107.
- Background: PubMed 12124869Prahalad S, Shear ES, Thompson SD, Giannini EH, Glass DN. Increased prevalence of familial autoimmunity in simplex and multiplex families with juvenile rheumatoid arthritis. Arthritis Rheum. 2002 Jul;46(7):1851-6. doi: 10.1002/art.10370.
- Background: PubMed 11083290Prahalad S, Ryan MH, Shear ES, Thompson SD, Glass DN, Giannini EH. Twins concordant for juvenile rheumatoid arthritis. Arthritis Rheum. 2000 Nov;43(11):2611-2. doi: 10.1002/1529-0131(200011)43:113.0.CO;2-T. No abstract available.
- Background: PubMed 11037894Prahalad S, Ryan MH, Shear ES, Thompson SD, Giannini EH, Glass DN. Juvenile rheumatoid arthritis: linkage to HLA demonstrated by allele sharing in affected sibpairs. Arthritis Rheum. 2000 Oct;43(10):2335-8. doi: 10.1002/1529-0131(200010)43:103.0.CO;2-W.
- Background: PubMed 19116909Hinks A, Ke X, Barton A, Eyre S, Bowes J, Worthington J, Thompson SD, Langefeld CD, Glass DN, Thomson W; UK Rheumatoid Arthritis Genetics Consortium; British Society of Paediatric and Adolescent Rheumatology Study Group. Association of the IL2RA/CD25 gene with juvenile idiopathic arthritis. Arthritis Rheum. 2009 Jan;60(1):251-7. doi: 10.1002/art.24187.
- Background: PubMed 17994193Zeft A, Shear ES, Thompson SD, Glass DN, Prahalad S. Familial autoimmunity: maternal parent-of-origin effect in juvenile idiopathic arthritis. Clin Rheumatol. 2008 Feb;27(2):241-4. doi: 10.1007/s10067-007-0778-8. Epub 2007 Nov 10.
- Background: PubMed 18576317Prahalad S, Bohnsack JF, Whiting A, Clifford B, Jorde LB, Guthery SL, Thompson SD, Glass DN, Bamshad MJ. Lack of association of functional CTLA4 polymorphisms with juvenile idiopathic arthritis. Arthritis Rheum. 2008 Jul;58(7):2147-52. doi: 10.1002/art.23602.
- Background: PubMed 16775617Prahalad S, Bohnsack JF, Jorde LB, Whiting A, Clifford B, Dunn D, Weiss R, Moroldo M, Thompson SD, Glass DN, Bamshad MJ. Association of two functional polymorphisms in the CCR5 gene with juvenile rheumatoid arthritis. Genes Immun. 2006 Sep;7(6):468-75. doi: 10.1038/sj.gene.6364317. Epub 2006 Jun 15.
- Background: PubMed 16896287Phelan JD, Thompson SD. Genomic progress in pediatric arthritis: recent work and future goals. Curr Opin Rheumatol. 2006 Sep;18(5):482-9. doi: 10.1097/01.bor.0000240359.30303.e4.
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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.
David N. Glass, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Juvenile Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 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 2 inclusion and 0 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 28 Sep 2022. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00090571, which also lists 15 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 28 Sep 2022.