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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

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ClinicalTrials.gov Identifier: NCT02418442
Recruitment Status : Recruiting
First Posted : April 16, 2015
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Childhood Arthritis and Rheumatology Research Alliance
Information provided by (Responsible Party):
Duke University

Brief Summary:
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Condition or disease
Rheumatic Joint Disease

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Study Start Date : July 2015
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : December 2028





Primary Outcome Measures :
  1. Prospectively collect essential data elements from children, adolescents and young adults with pediatric rheumatic diseases [ Time Frame: Approximately 10 years ]
  2. Evaluate the safety of therapeutic agents in persons with pediatric onset rheumatic diseases [ Time Frame: Approximately 10 years ]

Secondary Outcome Measures :
  1. Evaluate clinical outcomes associated with the use of therapeutic agents in persons with pediatric onset rheumatic diseases [ Time Frame: Approximately 10 years ]
  2. Document drug treatment patterns and clinical course of persons with pediatric onset rheumatic diseases over time. [ Time Frame: Approximately 10 years ]
  3. Evaluate factors other than drug treatments that are associated with clinical outcomes in pediatric onset rheumatic diseases [ Time Frame: Approximately 10 years ]

Biospecimen Retention:   Samples With DNA
The biosample collection will be in the future. This effort is currently not funded.


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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with pediatric rheumatic diseases enrolled from participating CARRA sites.
Criteria

Inclusion Criteria:

  1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
  2. Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
  3. Subject and/or parent/legal guardian can read either English or Spanish.
  4. Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.

Exclusion Criteria:

1. Greater than 21 years of age at the time of enrollment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418442


Contacts
Contact: Laura Schanberg, MD (919) 684-6601 Laura.Schanberg@duke.edu
Contact: Yukiko Kimura, MD 551-996-5306 YKimura@hackensackumc.org

  Show 63 Study Locations
Sponsors and Collaborators
Duke University
Childhood Arthritis and Rheumatology Research Alliance
Investigators
Principal Investigator: Laura Schanberg, MD Duke Clinical Research Insitute
Principal Investigator: Yuki Kimura, MD Hackensack Meridian Health
Principal Investigator: Timothy Beukelman, MD, MSCE University of Alabama at Birmingham

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02418442     History of Changes
Other Study ID Numbers: Pro00054616
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Keywords provided by Duke University:
Systemic Arthritis
Oligoarthritis
Polyarthritis (Rheumatoid Factor Negative)
Polyarthritis (Rheumatoid Factor Positive)
Psoriatic Arthritis
Enthesitis Related Arthritis (ERA)
Undifferianted Arthritis
CARRA Consensus Treatment Plans
FROST

Additional relevant MeSH terms:
Rheumatic Diseases
Joint Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatoid Factor
Immunologic Factors
Physiological Effects of Drugs