Start Time Optimization of Biologics in Polyarticular JIA
STOP-JIA
1 other identifier
observational
400
2 countries
55
Brief Summary
STOP-JIA is a PCORI funded prospective observational study which compared the clinical effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis \& Rheumatology Research Alliance (CARRA) consensus derived treatment strategies (CTPs) in new-onset polyarticular JIA (pJIA) patients to answer the critical question of when is the best time to begin biologic medications to achieve the optimal clinical and patient reported outcomes. Because the CARRA Registry will be used for data collection, all patients will be enrolled in the CARRA Registry. The standard of care treatments are chosen by the treating physician and patient/caregiver and are not randomized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedResults Posted
Study results publicly available
February 5, 2021
CompletedFebruary 5, 2021
February 1, 2021
3.9 years
October 29, 2015
December 12, 2019
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids
This is a provisional criteria which describes a state of complete disease inactivity in Juvenile Idiopathic Arthritis (JIA). We will assess the proportion of patients achieving CID off glucocorticoids in each treatment arm.
12 months after baseline
Secondary Outcomes (1)
Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups
12 months after baseline
Eligibility Criteria
Children with new onset, untreated Poly JIA enrolled in the CARRA Registry.
You may qualify if:
- Age less than 19 at baseline (if 18 or older, agrees to be followed for at least one year)
- Diagnosis of Arthritis per ACR definition.
- Arthritis present in one joint for a least six weeks
- At least 5 active joints at baseline
- Contraception if sexually active (male and female)
- May have any of the following:
- RF+ polyarticular JIA
- RF- polyarticular JIA
- Extended oligoarticular JIA
- Psoriatic JIA
- Enthesitis related JIA
- Undifferentiated JIA
- Psoriasis
- Sacroiliitis
- Uveitis
- +10 more criteria
You may not qualify if:
- Features consistent with systemic JIA
- Treatment with any medications for JIA aside from those listed above.
- Known inflammatory bowel disease
- Known celiac disease
- Known Trisomy 21
- History of or current malignancy
- Concomitant serious active or recurrent chronic bacterial, fungal or viral infection
- Significant organ system disorder limiting use of treatments for pJIA
- Live vaccine within a month prior to baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hackensack Meridian Healthlead
- Patient-Centered Outcomes Research Institutecollaborator
- Childhood Arthritis and Rheumatology Research Alliancecollaborator
- Duke Clinical Research Institutecollaborator
- Seattle Children's Hospitalcollaborator
- Children's Hospital of Philadelphiacollaborator
- Boston Children's Hospitalcollaborator
- The Hospital for Sick Childrencollaborator
- University Health Network, Torontocollaborator
Study Sites (55)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Rady Children's Hospital-San Diego
San Diego, California, 92123, United States
University of California at San Francisco Medical Center
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
University of Florida Shand's Children's Hospital
Gainesville, Florida, 32608, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Georgia Regents University Medical Center
Augusta, Georgia, 30912, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville School of Medicine
Louisville, Kentucky, 40202, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center, High Street Health Center
Springfield, Massachusetts, 01105, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Saint Louis University School of Medicine
St Louis, Missouri, 63104, United States
Saint Louis Children's Hospital
St Louis, Missouri, 63110, United States
HackensackUniversity Medical Center
Hackensack, New Jersey, 07601, United States
Goryeb Children's Hospital
Morristown, New Jersey, 07960, United States
Pediatric Specialty Center at Saint Barnabas
West Orange, New Jersey, 07052, United States
Albany Medical College
Albany, New York, 12208, United States
Cohen Children's Medical Center of New York
Lake Success, New York, 11042, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MetroHealth Medical Center
Cleveland, Ohio, 044109, United States
UH Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Clevland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390, United States
Baylor College of Medicine Pediatric Immunology, Allergy and Rheumatology
Houston, Texas, 77030-2399, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Wisconsin-American Family Children's Hospital
Madison, Wisconsin, 53792, United States
University of Calgary- Alberta Children's Hospital
Calgary, Alberta, AB T3B, Canada
IWK Health Center
Halifax, Nova Scotia, NS B3K 6R8, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (2)
Kimura Y, Schanberg LE, Tomlinson GA, Riordan ME, Dennos AC, Del Gaizo V, Murphy KL, Weiss PF, Natter MD, Feldman BM, Ringold S; CARRA STOP-JIA Investigators. Optimizing the Start Time of Biologics in Polyarticular Juvenile Idiopathic Arthritis: A Comparative Effectiveness Study of Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans. Arthritis Rheumatol. 2021 Oct;73(10):1898-1909. doi: 10.1002/art.41888. Epub 2021 Sep 3.
PMID: 34105312DERIVEDOng MS, Ringold S, Kimura Y, Schanberg LE, Tomlinson GA, Natter MD; CARRA Registry Investigators. Improved Disease Course Associated With Early Initiation of Biologics in Polyarticular Juvenile Idiopathic Arthritis: Trajectory Analysis of a Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans Study. Arthritis Rheumatol. 2021 Oct;73(10):1910-1920. doi: 10.1002/art.41892. Epub 2021 Aug 27.
PMID: 34105303DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yukiko Kimura MD
- Organization
- Hackensack University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Yukiko Kimura, MD
Hackensack Meridian Health
- PRINCIPAL INVESTIGATOR
Sarah Ringold, MD
Seattle Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2015
First Posted
October 30, 2015
Study Start
November 1, 2015
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
February 5, 2021
Results First Posted
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- IPD will be available for requests through the CARRA data and sample request portal once the PCORI Final Research Report has been approved and is publicly available. There is no time limit.
- Access Criteria
- Investigators may request data through the CARRA data and sample share request portal. Inquiries may be sent to research@carragroup.org.
Key outcome data, treatment data and baseline characteristics will be shared with other researchers upon request and are subject to the CARRA data and sample sharing policy (https://carragroup.org/UserFiles/file/CARRA-DATA-SAMPLE-SHARING-POLICY-04November2016.pdf). Documentation of appropriate IRB/ethics board approval will be required.