Polyarticular Juvenile Rheumatoid ArthritisSTOP-JIANCT02593006
Start Time Optimization of Biologics in Polyarticular JIA
An observational study of Polyarticular Juvenile Rheumatoid Arthritis and Arthritis, Juvenile Idiopathic, run by Hackensack Meridian Health at 55 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Polyarticular Juvenile Rheumatoid Arthritis, Arthritis, Juvenile Idiopathic
- How many people
- 400 participants
- Where
- 55 sitesin 2 countries
- Study dates
- Nov 2015to 30 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with new onset, untreated Poly JIA enrolled in the CARRA Registry.
Who may be able to join
- 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:
Show all 25Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States52 sites
Albany Medical College
Albany, New York, 12208
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Emory Children's Center
Atlanta, Georgia, 30322
Georgia Regents University Medical Center
Augusta, Georgia, 30912
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Vermont Medical Center
Burlington, Vermont, 05401
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
Levine Children's Hospital
Charlotte, North Carolina, 28203
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
MetroHealth Medical Center
Cleveland, Ohio, 044109
UH Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Clevland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705
University of Florida Shand's Children's Hospital
Gainesville, Florida, 32608
HackensackUniversity Medical Center
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Baylor College of Medicine Pediatric Immunology, Allergy and Rheumatology
Houston, Texas, 77030-2399
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Mercy Hospital
Kansas City, Missouri, 64108
Cohen Children's Medical Center of New York
Lake Success, New York, 11042
University of Louisville School of Medicine
Louisville, Kentucky, 40202
University of Wisconsin-American Family Children's Hospital
Madison, Wisconsin, 53792
University of Minnesota
Minneapolis, Minnesota, 55455
Goryeb Children's Hospital
Morristown, New Jersey, 07960
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
New York University Langone Medical Center
New York, New York, 10016
Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Stanford University Medical Center
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227
Mayo Clinic
Rochester, Minnesota, 55902
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84112
Rady Children's Hospital-San Diego
San Diego, California, 92123
University of California at San Francisco Medical Center
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98105
Baystate Medical Center, High Street Health Center
Springfield, Massachusetts, 01105
Saint Louis University School of Medicine
St Louis, Missouri, 63104
Saint Louis Children's Hospital
St Louis, Missouri, 63110
Children's Hospital at Montefiore
The Bronx, New York, 10467
Pediatric Specialty Center at Saint Barnabas
West Orange, New Jersey, 07052
Canada3 sites
University of Calgary- Alberta Children's Hospital
Calgary, Alberta, AB T3B
IWK Health Center
Halifax, Nova Scotia, NS B3K 6R8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
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.
Read the 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.
- Keywords
- Joint Diseases, Juvenile Arthritis, treatment, biologic therapy, comparative effectiveness
- Medical subject headings
- Arthritis, Juvenile, Joint Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after baseline
Secondary outcomes (1)
Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups
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.
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polyarticular Juvenile Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Childhood Arthritis and Rheumatology Research Alliance, Duke Clinical Research Institute, Seattle Children's Hospital, Children's Hospital of Philadelphia, Boston Children's Hospital, The Hospital for Sick Children, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Yukiko Kimura, MD, Principal investigator, Hackensack Meridian HealthSarah Ringold, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593006
- Sponsor's protocol ID
- Pro5835
- Acronym
- STOP-JIA
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2015
- Last updated
- 5 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34105312Ong 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.
PubMed 34105303
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Start Time Optimization of Biologics in Polyarticular JIA
- ClinicalTrials.gov ID
- NCT02593006
- Acronym / sponsor ID
- STOP-JIA / Pro5835
- Keywords
- Joint Diseases, Juvenile Arthritis, treatment, biologic therapy, comparative effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Childhood Arthritis and Rheumatology Research Alliance, Duke Clinical Research Institute, Seattle Children's Hospital, Children's Hospital of Philadelphia, Boston Children's Hospital, The Hospital for Sick Children, University Health Network, Toronto
- Study start
- Nov 2015
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with new onset, untreated Poly JIA enrolled in the CARRA Registry.
Key inclusion criteria (25 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups
Time frame: 12 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34105312Kimura 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.
- Derived from this study: PubMed 34105303Ong 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.
- Click here for more information on the Observational Study of Pediatric Rheumatic Diseases: The CARRA RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yukiko Kimura, MD principal investigator
Hackensack Meridian Health
Sarah Ringold, MD principal investigator
Seattle Children's Hospital
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyarticular Juvenile Rheumatoid Arthritis and Arthritis, Juvenile Idiopathic, run by Hackensack Meridian Health at 55 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids (time frame: 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593006, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.