Juvenile Idiopathic ArthritisCARRA RegistryNCT01697254
The CARRA Registry
An observational study of Juvenile Idiopathic Arthritis and Systemic Lupus Erythematosus, run by Duke University at 1 site in United States.
Trial summary
This CARRA Registry study will create a foundational database for rheumatic diseases of childhood using a novel informatics infrastructure developed as part of the larger clinical project. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, Mixed Connective Tissue Disease
- How many people
- 9,587 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2015
- How long will I take part?
- 10 Years
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be recruited from the patient population of a CARRA Registry site.
Who may be able to join
- Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 18 years for all other rheumatic diseases
- Subject has been diagnosed with a defined pediatric rheumatic disease including: Mixed Connective Tissue Disease (MCTD), Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Systemic Sclerosis (SS), Juvenile Dermatomyositis (JDM), Localized Scleroderma (LS), Juvenile Idiopathic Arthritis (JIA), Vasculitis, Sarcoid, Auto-inflammatory Diseases, Idiopathic Uveitis (IU), and Juvenile Primary Fibromyalgia Syndrome (JPFS).
- Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27705
About this study
This CARRA Registry study will create a foundational database for rheumatic diseases of childhood using a novel informatics infrastructure developed as part of the larger clinical project. The creation of a CARRA-wide informatics infrastructure will enable efficient, observational, disease-related data capture across all CARRA sites for pediatric rheumatic diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data intensive registries for observational studies, comparative effectiveness research, pharmaceutical clinical trials and translational research.
Read the detailed description
This protocol represents one aim of a larger clinical project that will advance the infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) network, facilitate expanded clinical and translational pediatric research, and rapidly transform the culture of pediatric rheumatology toward universal participation in research. Through the creation of sophisticated informatics infrastructure, provision of comprehensive site support and the engagement of families, patients, and communities, CARRA will provide the opportunity for affected children at every CARRA site to participate in high quality clinical and translational research.
The larger clinical project includes development of a CARRA-wide informatics platform with capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of validated disease metrics and relevant subject demographics, utilizing centralized Electronic Data Capture (EDC) and phone interviews where appropriate, and ontology-based data storage using a distributed database structure based on the NIH-supported i2b2 (Informatics Integrating Biology and the Bedside) framework. This will enable efficient, observational, disease-related data capture across CARRA sites. The CARRA Registry described in this protocol will form the foundational database and will involve the capture of data including pediatric rheumatic diseases as described in Appendix A.
The CARRA Registry will support data collection from the use of consensus treatment plans (CTPs), clinical trials, observational disease registries, comparative effectiveness research, and other research on patients with pediatric rheumatic disease. The CARRA Registry will form the basis for future CARRA studies and the Duke Clinical Research Institute (DCRI) is serving as the CARRA Data Coordinating Center (DCC) for this protocol.
- Conditions
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Juvenile Ankylosing Spondylitis, Juvenile Dermatomyositis, Localized Scleroderma
- Medical subject headings
- Arthritis, Juvenile, Lupus Erythematosus, Systemic, Mixed Connective Tissue Disease, Dermatomyositis, Scleroderma, Localized, Scleroderma, Systemic, Vasculitis, Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrolled Subjects
This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startAug 2009
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 9,587 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation, Lupus Foundation of America, Cure JM Foundation
- Responsible party
- Sponsor
- Investigators
- Laura Schanberg, MD, Principal investigator, Duke UniversityNorman T Illowite, MD, Principal investigator, Children's Hospital at MontefioreChristy Sandborg, MD, Principal investigator, Lucile Salter Packard Children's Hospital/Stanford University School of MedicineCarol Wallace, MD, Principal investigator, Seattle Children's Hospital/ University of Washington School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697254
- Sponsor's protocol ID
- Pro00018979
- Other IDs
- 1RC2AE058934-01
- Acronym
- CARRA Registry
- Status last verified
- Nov 2015
- First submitted
- 28 Sep 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Robinson AB, Hoeltzel MF, Wahezi DM, Becker ML, Kessler EA, Schmeling H, Carrasco R, Huber AM, Feldman BM, Reed AM; Juvenile Myositis CARRA Subgroup, for the CARRA Registry Investigators. Clinical characteristics of children with juvenile dermatomyositis: the Childhood Arthritis and Rheumatology Research Alliance Registry. Arthritis Care Res (Hoboken). 2014 Mar;66(3):404-10. doi: 10.1002/acr.22142.
PubMed 23983017Natter MD, Quan J, Ortiz DM, Bousvaros A, Ilowite NT, Inman CJ, Marsolo K, McMurry AJ, Sandborg CI, Schanberg LE, Wallace CA, Warren RW, Weber GM, Mandl KD. An i2b2-based, generalizable, open source, self-scaling chronic disease registry. J Am Med Inform Assoc. 2013 Jan 1;20(1):172-9. doi: 10.1136/amiajnl-2012-001042. Epub 2012 Jun 25.
PubMed 22733975Beukelman T, Ringold S, Davis TE, DeWitt EM, Pelajo CF, Weiss PF, Kimura Y; CARRA Registry Investigators. Disease-modifying antirheumatic drug use in the treatment of juvenile idiopathic arthritis: a cross-sectional analysis of the CARRA Registry. J Rheumatol. 2012 Sep;39(9):1867-74. doi: 10.3899/jrheum.120110. Epub 2012 Aug 1.
PubMed 22859354Ringold S, Beukelman T, Nigrovic PA, Kimura Y; CARRA Registry Site Principal Investigators. Race, ethnicity, and disease outcomes in juvenile idiopathic arthritis: a cross-sectional analysis of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. J Rheumatol. 2013 Jun;40(6):936-42. doi: 10.3899/jrheum.121147. Epub 2013 Apr 15.
PubMed 23588937Weiss PF, Beukelman T, Schanberg LE, Kimura Y, Colbert RA; CARRA Registry Investigators. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012 Dec;39(12):2341-51. doi: 10.3899/jrheum.120642. Epub 2012 Oct 15.
PubMed 23070991Kimura Y, Weiss JE, Haroldson KL, Lee T, Punaro M, Oliveira S, Rabinovich E, Riebschleger M, Anton J, Blier PR, Gerloni V, Hazen MM, Kessler E, Onel K, Passo MH, Rennebohm RM, Wallace CA, Woo P, Wulffraat N; Childhood Arthritis Rheumatology Research Alliance Carra Net Investigators. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):745-52. doi: 10.1002/acr.21889.
PubMed 23139240Kimura Y, Grevich S, Beukelman T, Morgan E, Nigrovic PA, Mieszkalski K, Graham TB, Ibarra M, Ilowite N, Klein-Gitelman M, Onel K, Prahalad S, Punaro M, Ringold S, Toib D, Van Mater H, Weiss JE, Weiss PF, Schanberg LE; CARRA Registry Investigators. Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. Pediatr Rheumatol Online J. 2017 Apr 11;15(1):23. doi: 10.1186/s12969-017-0157-1.
PubMed 28399931
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CARRA Registry
- ClinicalTrials.gov ID
- NCT01697254
- Acronym / sponsor ID
- CARRA Registry / Pro00018979
- Conditions
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Juvenile Ankylosing Spondylitis, Juvenile Dermatomyositis, Localized Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,587 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation, Lupus Foundation of America, Cure JM Foundation
- Study start
- Aug 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Oct 2012 (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 CARRA Registry study will create a foundational database for rheumatic diseases of childhood using a novel informatics infrastructure developed as part of the larger clinical project. The creation of a CARRA-wide informatics infrastructure will enable efficient, observational, disease-related data capture across all CARRA sites for pediatric rheumatic diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data intensive registries for observational studies, comparative effectiveness research, pharmaceutical clinical trials and translational research.
Detailed description
This protocol represents one aim of a larger clinical project that will advance the infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) network, facilitate expanded clinical and translational pediatric research, and rapidly transform the culture of pediatric rheumatology toward universal participation in research. Through the creation of sophisticated informatics infrastructure, provision of comprehensive site support and the engagement of families, patients, and communities, CARRA will provide the opportunity for affected children at every CARRA site to participate in high quality clinical and translational research.
The larger clinical project includes development of a CARRA-wide informatics platform with capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of validated disease metrics and relevant subject demographics, utilizing centralized Electronic Data Capture (EDC) and phone interviews where appropriate, and ontology-based data storage using a distributed database structure based on the NIH-supported i2b2 (Informatics Integrating Biology and the Bedside) framework. This will enable efficient, observational, disease-related data capture across CARRA sites. The CARRA Registry described in this protocol will form the foundational database and will involve the capture of data including pediatric rheumatic diseases as described in Appendix A.
The CARRA Registry will support data collection from the use of consensus treatment plans (CTPs), clinical trials, observational disease registries, comparative effectiveness research, and other research on patients with pediatric rheumatic disease. The CARRA Registry will form the basis for future CARRA studies and the Duke Clinical Research Institute (DCRI) is serving as the CARRA Data Coordinating Center (DCC) for this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from the patient population of a CARRA Registry site.
Key inclusion criteria (3 listed)
- Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 18 years for all other rheumatic diseases
- Subject has been diagnosed with a defined pediatric rheumatic disease including: Mixed Connective Tissue Disease (MCTD), Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Systemic Sclerosis (SS), Juvenile Dermatomyositis (JDM), Localized Scleroderma (LS), Juvenile Idiopathic Arthritis (JIA), Vasculitis, Sarcoid, Auto-inflammatory Diseases, Idiopathic Uveitis (IU), and Juvenile Primary Fibromyalgia Syndrome (JPFS).
- Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
Key exclusion criteria (1 listed)
- None
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
Enrolled Subjects
Time frame: baseline
This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.
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 17 Nov 2015.
- Background: PubMed 23983017Robinson AB, Hoeltzel MF, Wahezi DM, Becker ML, Kessler EA, Schmeling H, Carrasco R, Huber AM, Feldman BM, Reed AM; Juvenile Myositis CARRA Subgroup, for the CARRA Registry Investigators. Clinical characteristics of children with juvenile dermatomyositis: the Childhood Arthritis and Rheumatology Research Alliance Registry. Arthritis Care Res (Hoboken). 2014 Mar;66(3):404-10. doi: 10.1002/acr.22142.
- Results publication: PubMed 22733975Natter MD, Quan J, Ortiz DM, Bousvaros A, Ilowite NT, Inman CJ, Marsolo K, McMurry AJ, Sandborg CI, Schanberg LE, Wallace CA, Warren RW, Weber GM, Mandl KD. An i2b2-based, generalizable, open source, self-scaling chronic disease registry. J Am Med Inform Assoc. 2013 Jan 1;20(1):172-9. doi: 10.1136/amiajnl-2012-001042. Epub 2012 Jun 25.
- Results publication: PubMed 22859354Beukelman T, Ringold S, Davis TE, DeWitt EM, Pelajo CF, Weiss PF, Kimura Y; CARRA Registry Investigators. Disease-modifying antirheumatic drug use in the treatment of juvenile idiopathic arthritis: a cross-sectional analysis of the CARRA Registry. J Rheumatol. 2012 Sep;39(9):1867-74. doi: 10.3899/jrheum.120110. Epub 2012 Aug 1.
- Results publication: PubMed 23588937Ringold S, Beukelman T, Nigrovic PA, Kimura Y; CARRA Registry Site Principal Investigators. Race, ethnicity, and disease outcomes in juvenile idiopathic arthritis: a cross-sectional analysis of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. J Rheumatol. 2013 Jun;40(6):936-42. doi: 10.3899/jrheum.121147. Epub 2013 Apr 15.
- Results publication: PubMed 23070991Weiss PF, Beukelman T, Schanberg LE, Kimura Y, Colbert RA; CARRA Registry Investigators. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012 Dec;39(12):2341-51. doi: 10.3899/jrheum.120642. Epub 2012 Oct 15.
- Results publication: PubMed 23139240Kimura Y, Weiss JE, Haroldson KL, Lee T, Punaro M, Oliveira S, Rabinovich E, Riebschleger M, Anton J, Blier PR, Gerloni V, Hazen MM, Kessler E, Onel K, Passo MH, Rennebohm RM, Wallace CA, Woo P, Wulffraat N; Childhood Arthritis Rheumatology Research Alliance Carra Net Investigators. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):745-52. doi: 10.1002/acr.21889.
- Derived from this study: PubMed 28399931Kimura Y, Grevich S, Beukelman T, Morgan E, Nigrovic PA, Mieszkalski K, Graham TB, Ibarra M, Ilowite N, Klein-Gitelman M, Onel K, Prahalad S, Punaro M, Ringold S, Toib D, Van Mater H, Weiss JE, Weiss PF, Schanberg LE; CARRA Registry Investigators. Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. Pediatr Rheumatol Online J. 2017 Apr 11;15(1):23. doi: 10.1186/s12969-017-0157-1.
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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.
Laura Schanberg, MD principal investigator
Duke University
Norman T Illowite, MD principal investigator
Children's Hospital at Montefiore
Christy Sandborg, MD principal investigator
Lucile Salter Packard Children's Hospital/Stanford University School of Medicine
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 Idiopathic Arthritis and Systemic Lupus Erythematosus, run by Duke University 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 3 inclusion and 1 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 17 Nov 2015. 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?
Enrolled Subjects (time frame: baseline). 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 NCT01697254, which also lists 7 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 17 Nov 2015.