- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02593006
Start Time Optimization of Biologics in Polyarticular JIA (STOP-JIA)
Study Overview
Status
Detailed Description
STOP-JIA is a prospective, observational study comparing the clinical effectiveness and impact on patient reported outcomes of 3 different treatment strategies (CTPs) in new onset pJIA patients to answer the critical question of when to start biologic medications. All participants will be enrolled in the CARRA Registry and started on one of the CTPs, which will be decided by the treating physician and patient/caregiver. Subjects will be enrolled at one of 60 participating CARRA sites across the US and Canada. Total anticipated enrollment was 400 and this was completed in 9/19.
Specific Aim 1:
To compare the clinical effectiveness of different strategies (CTPs) for using biologic medications in achieving clinically inactive disease (CID) at 12 months in new-onset pJIA. Three common strategies that differ in the timing of biologic medication introduction will be compared: 1) Step-Up: disease modifying anti-rheumatic drug (DMARD) monotherapy stepping up by addition of a biologic medication if needed; 2) Early Combination: DMARD plus biologic medication at treatment onset; and 3) Biologic First: biologic medication monotherapy at treatment onset.
Hypothesis 1: A significantly higher proportion of children started on a biologic medication at onset (CTP 2 or 3) will achieve CID after 12 months of therapy compared to standard therapy (CTP 1).
Specific Aim 2:
To compare patient and caregiver reported outcomes between the different strategies.
Hypothesis 2: There will be statistically significant differences in patient/caregiver reported outcomes (PROs) between treatment strategies that can inform future patients and providers in selecting optimal treatments.
The CARRA Registry will be housed at CARRA's clinical and data coordinating center, Duke Clinical Research Institute (DCRI). The CARRA Registry Protocol documents that the CARRA Registry fulfills all PCOR standards for registries. STOP-JIA will utilize data collection, storage, and management processes, systems requirements, and security processes already established for the CARRA Registry at DCRI.
STOP-JIA used Web-based electronic CRFs (eCRFs) developed for the CARRA Registry that are already familiar to site personnel. The eCRF platform, RAVE, is 21CFR part11 compliant and meets regulatory requirements. Database and Web servers are secured by a firewall and through controlled physical access. eCRFs will be monitored for completeness, accuracy, and attention to detail throughout the study by DCRI data and site management teams using processes developed for the CARRA Registry and consistent with DCRI's internal SOPs. Use of electronic data capture will allow for immediate prompts/queries if entered values are out of expected ranges or there are incomplete data fields. The design of the data collection instrument will allow centers to record a planned assessment of a patient was missed and to enter any known reasons for the assessment being missed. DCRI will regularly provide reports detailing data completion metrics to the sites. Stakeholder engagement is also an important aspect of this study, and patients/caregivers as well as other stakeholders are serving as research partners and advisors in this study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, AB T3B
- University of Calgary- Alberta Children's Hospital
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, NS B3K 6R8
- IWK Health Center
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University Medical Center
-
San Diego, California, United States, 92123
- Rady Children's Hospital-San Diego
-
San Francisco, California, United States, 94143
- University of California at San Francisco Medical Center
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
-
-
Florida
-
Gainesville, Florida, United States, 32608
- University of Florida Shand's Children's Hospital
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory Children's Center
-
Augusta, Georgia, United States, 30912
- Georgia Regents University Medical Center
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville School of Medicine
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
Springfield, Massachusetts, United States, 01105
- Baystate Medical Center, High Street Health Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
Rochester, Minnesota, United States, 55902
- Mayo Clinic
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
Saint Louis, Missouri, United States, 63104
- Saint Louis University School of Medicine
-
Saint Louis, Missouri, United States, 63110
- Saint Louis Children's Hospital
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- HackensackUniversity Medical Center
-
Morristown, New Jersey, United States, 07960
- Goryeb Children's Hospital
-
West Orange, New Jersey, United States, 07052
- Pediatric Specialty Center at Saint Barnabas
-
-
New York
-
Albany, New York, United States, 12208
- Albany Medical College
-
Bronx, New York, United States, 10467
- Children's Hospital at Montefiore
-
Lake Success, New York, United States, 11042
- Cohen Children's Medical Center of New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
New York, New York, United States, 10016
- New York University Langone Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28203
- Levine Children's Hospital
-
Durham, North Carolina, United States, 27705
- Duke Children's Hospital & Health Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, United States, 44106
- UH Rainbow Babies and Children's Hospital
-
Cleveland, Ohio, United States, 044109
- MetroHealth Medical Center
-
Cleveland, Ohio, United States, 44195
- Clevland Clinic Foundation
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Randall Children's Hospital at Legacy Emanuel
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, United States, 19134
- St. Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina Children's Hospital
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Monroe Carell Jr. Children's Hospital at Vanderbilt
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center Dallas
-
Houston, Texas, United States, 77030-2399
- Baylor College of Medicine Pediatric Immunology, Allergy and Rheumatology
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- University of Utah Hospitals and Clinics
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
-
-
Washington
-
Seattle, Washington, United States, 98105
- Seattle Children's Hospital
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin-American Family Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- Enthesitis
Prior treatments permitted:
- NSAIDS
- Hydroxychloroquine
- Intraocular / topical / intraarticular glucocorticoids
IV or PO steroids if one of the below criteria are met:
--If treated ≤ 3 months prior to baseline: treatment cannot exceed 2 weeks
--If treated > 3 months prior to baseline: any treatment course is permitted as long as treatment was completed 90 days prior to baseline
- Methotrexate started no more than 1 month prior to the baseline visit
- Biologics - received only 1 dose within 1 week of the baseline visit
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids
Time Frame: 12 months after baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups
Time Frame: 12 months after baseline
|
The Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and mobility scores will be compared between the 3 CTP groups.
Pain interference scores range from 0-100 and higher scores are worse.
Mobility scores also range from 0-100 and higher scores are better.
|
12 months after baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yukiko Kimura, MD, Hackensack Meridian Health
- Principal Investigator: Sarah Ringold, MD, Seattle Children's Hospital
Publications and helpful links
General Publications
- 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.
- Ong 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro5835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polyarticular Juvenile Rheumatoid Arthritis
-
University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
-
Bristol-Myers SquibbCompletedActive Polyarticular Juvenile Idiopathic ArthritisUnited States, Spain, Belgium, Italy, Argentina, Brazil, France, Germany, Mexico, Peru, Russian Federation, South Africa
-
Chugai PharmaceuticalCompletedPolyarticular Juvenile Idiopathic Arthritis
-
AbbVieCompletedPolyarticular Juvenile ArthritisRussian Federation
-
AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
-
ItalfarmacoTerminatedPolyarticular Course Juvenile Idiopathic ArthritisBelgium, Spain, Serbia, Czech Republic, Italy, Romania, Slovenia
-
AbbVieRecruitingPolyarticular Juvenile Idiopathic ArthritisChina
-
UCB BIOSCIENCES GmbHPRA Health SciencesCompletedPolyarticular-course Juvenile Idiopathic Arthritis (JIA)United States, Argentina, Brazil, Canada, Chile, Mexico, Russian Federation
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
PfizerNot yet recruitingPolyarticular Juvenile Idiopathic Arthritis | Psoriatic Arthritis, JuvenileKorea, Republic of