Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

NCT02418442 | Recruiting

• 1 other identifier: Pro00054616
• Study Type: observational
• Target: 20,000
• Locations: 5 countries
• Sites: 82

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.

Conditions

Rheumatic Joint Disease

Keywords

Systemic Arthritis; Oligoarthritis; Polyarthritis (Rheumatoid Factor Negative); Polyarthritis (Rheumatoid Factor Positive); Psoriatic Arthritis; Enthesitis Related Arthritis (ERA); Undifferianted Arthritis; CARRA Consensus Treatment Plans

Outcome Measures

Primary Outcomes (2)

• Prospectively collect essential data elements from children, adolescents and young adults with pediatric rheumatic diseases

  Approximately 10 years

• Evaluate the safety of therapeutic agents in persons with pediatric onset rheumatic diseases

  Approximately 10 years

Secondary Outcomes (3)

• Evaluate clinical outcomes associated with the use of therapeutic agents in persons with pediatric onset rheumatic diseases

  Approximately 10 years

• Document drug treatment patterns and clinical course of persons with pediatric onset rheumatic diseases over time.

  Approximately 10 years

• Evaluate factors other than drug treatments that are associated with clinical outcomes in pediatric onset rheumatic diseases

  Approximately 10 years

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with pediatric rheumatic diseases enrolled from participating CARRA sites.

You may qualify if:

• 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).
• Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
• Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.

You may not qualify if:

• \. Greater than 21 years of age at the time of enrollment.

Sponsors & Collaborators

• Duke University: lead
• Childhood Arthritis and Rheumatology Research Alliance: collaborator

Study Sites (82)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, 85254, United States

RECRUITING

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

NOT YET RECRUITING

Mattel Children's Hospital at University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Stanford University Medical Center

Palo Alto, California, 94304, United States

RECRUITING

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

University of California at San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

The Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

TERMINATED

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Florida - Shand's Children's Hospital

Gainesville, Florida, 32608, United States

RECRUITING

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

RECRUITING

Nemours Children's Hospital

Orlando, Florida, 32827, United States

RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Emory Children's Center

Atlanta, Georgia, 30322, United States

RECRUITING

Georgia Regents University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

WITHDRAWN

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

The University of Iowa Hospitals and Clinics (University of Iowa Children's Hospital)

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

TERMINATED

University of Louisville Schoole of Medicine

Louisville, Kentucky, 40202, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital for Children

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Bay State Medical Center

Springfield, Massachusetts, 01105, United States

TERMINATED

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Helen Devos Children's Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

West Michigan Rheumatology

Grand Rapids, Michigan, 49546, United States

TERMINATED

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Saint Louis University School of Medicine

St Louis, Missouri, 63104, United States

RECRUITING

Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Goryeb Children's Hospital

Morristown, New Jersey, 07960, United States

RECRUITING

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

The Pediatric Specialty Center at Saint Barnabas

West Orange, New Jersey, 07052, United States

RECRUITING

Albany Medical College

Albany, New York, 122089, United States

RECRUITING

Cohen Children's Medical Center of New York

Lake Success, New York, 11042, United States

RECRUITING

New York University Langone Medical Center

New York, New York, 10016, United States

TERMINATED

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Children's Hospital at Montefiore

New York, New York, 10467, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Levine Children's Hospital / Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Duke Children's Hospital & Health Center

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest Baptist Brenner Children's Hospital

Winston-Salem, North Carolina, 27012, United States

RECRUITING

Sanford Health

Fargo, North Dakota, 58122, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

UH Rainbox Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

TERMINATED

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, 97227, United States

RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

Children's Hospital of Pittsburgh UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, 29425, United States

RECRUITING

Monroe Carrell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Southwestern Medical Center Dallas

Dallas, Texas, 75219, United States

RECRUITING

Baylor College of Medicine Pediatric Immunology Allergy Rheumatology

Houston, Texas, 77030, United States

RECRUITING

University of Utah Hospitals and Clinics (Primary Children's Hospital)

Salt Lake City, Utah, 84113, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

University of Wisconsin, American Family Children's Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Children's Hospital Of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

RECRUITING

University of Calgary - Alberta Children's Hospital

Calgary, Alberta, AB T38 6A8, Canada

RECRUITING

University of Manitoba - Children's Hospital of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

IWK Health Center

Halifax, Nova Scotia, NS B3K 6R8, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Schneider Children's Medical Center of Israel

Petah Tikva, 49202-35, Israel

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu (OPBG)

Rome, Italy

NOT YET RECRUITING

San Jorge Children's Hospital

San Juan, 00912, Puerto Rico

WITHDRAWN

Related Publications (1)

• Nigrovic PA, Beukelman T, Tomlinson G, Feldman BM, Schanberg LE, Kimura Y; Childhood Arthritis and Rheumatology Research Alliance Systemic Juvenile Idiopathic Arthritis Consensus Treatment Plan Workgroup. Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST). Clin Trials. 2018 Jun;15(3):268-277. doi: 10.1177/1740774518761367. Epub 2018 Mar 15.

  PMID: 29542334 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biosample collection is active for a subset of subjects within the registry

MeSH Terms

Conditions

Arthritis; Negative rheumatoid factor polyarthritis; Arthritis, Psoriatic; Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mara L Becker, MD, MSCE

  Duke Clinical Research Insitute

  PRINCIPAL INVESTIGATOR

• Mary Beth Son, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Timothy Beukelman, MD, MSCE

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara L Becker, MD, MSCE

CONTACT

(919) 419-5032; mara.becker@duke.edu

Mary Beth Son, MD

CONTACT

(617) 919-6083; marybeth.son@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: July 1, 2015
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

IT (1); IL (1); US (75); CA (4); PR (1)