Start Time Optimization of Biologics in Polyarticular JIA (STOP-JIA)

February 4, 2021 updated by: Hackensack Meridian Health
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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • 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
  • United States
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with new onset, untreated Poly JIA enrolled in the CARRA Registry.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

Patient-Centered Outcomes Research Institute
The Hospital for Sick Children
University Health Network, Toronto
Children's Hospital of Philadelphia
Boston Children's Hospital
Seattle Children's Hospital
Duke Clinical Research Institute
Childhood Arthritis and Rheumatology Research Alliance

Investigators

  • Principal Investigator: Yukiko Kimura, MD, Hackensack Meridian Health
  • Principal Investigator: Sarah Ringold, MD, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro5835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Investigators may request data through the CARRA data and sample share request portal. Inquiries may be sent to research@carragroup.org.

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.

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