Start Time Optimization of Biologics in Polyarticular JIA
- Conditions
- Polyarticular Juvenile Rheumatoid ArthritisArthritis, Juvenile Idiopathic
- Registration Number
- NCT02593006
- Lead Sponsor
- Hackensack Meridian Health
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
-
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids 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.
- Secondary Outcome Measures
Name Time Method Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups 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.
Trial Locations
- Locations (55)
Emory Children's Center
🇺🇸Atlanta, Georgia, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Saint Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Goryeb Children's Hospital
🇺🇸Morristown, New Jersey, United States
Albany Medical College
🇺🇸Albany, New York, United States
Rady Children's Hospital-San Diego
🇺🇸San Diego, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Georgia Regents University Medical Center
🇺🇸Augusta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Baystate Medical Center, High Street Health Center
🇺🇸Springfield, Massachusetts, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Saint Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
HackensackUniversity Medical Center
🇺🇸Hackensack, New Jersey, United States
Pediatric Specialty Center at Saint Barnabas
🇺🇸West Orange, New Jersey, United States
Cohen Children's Medical Center of New York
🇺🇸Lake Success, New York, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
UH Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Clevland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine Pediatric Immunology, Allergy and Rheumatology
🇺🇸Houston, Texas, United States
IWK Health Center
🇨🇦Halifax, Nova Scotia, Canada
University of Calgary- Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California at San Francisco Medical Center
🇺🇸San Francisco, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Florida Shand's Children's Hospital
🇺🇸Gainesville, Florida, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
Duke Children's Hospital & Health Center
🇺🇸Durham, North Carolina, United States
University of Wisconsin-American Family Children's Hospital
🇺🇸Madison, Wisconsin, United States
Randall Children's Hospital at Legacy Emanuel
🇺🇸Portland, Oregon, United States
Medical University of South Carolina Children's Hospital
🇺🇸Charleston, South Carolina, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States