Start Time Optimization of Biologics in Polyarticular JIA

Arthritis, Juvenile Idiopathic Clinical Trial

— STOP-JIA  

Official title:

Start Time Optimization of Biologics in Polyarticular JIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593006
• Other study ID #: Pro5835
• Status: Completed
• Start date: November 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2021
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Idiopathic
• Polyarticular Juvenile Rheumatoid Arthritis

Locations

Country	Name	City	State
Canada	University of Calgary- Alberta Children's Hospital	Calgary	Alberta
Canada	IWK Health Center	Halifax	Nova Scotia
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Albany Medical College	Albany	New York
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory Children's Center	Atlanta	Georgia
United States	Georgia Regents University Medical Center	Augusta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Children's Hospital at Montefiore	Bronx	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Medical University of South Carolina Children's Hospital	Charleston	South Carolina
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Clevland Clinic Foundation	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	UH Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center Dallas	Dallas	Texas
United States	Duke Children's Hospital & Health Center	Durham	North Carolina
United States	University of Florida Shand's Children's Hospital	Gainesville	Florida
United States	HackensackUniversity Medical Center	Hackensack	New Jersey
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Baylor College of Medicine Pediatric Immunology, Allergy and Rheumatology	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cohen Children's Medical Center of New York	Lake Success	New York
United States	University of Louisville School of Medicine	Louisville	Kentucky
United States	University of Wisconsin-American Family Children's Hospital	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Goryeb Children's Hospital	Morristown	New Jersey
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
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	Randall Children's Hospital at Legacy Emanuel	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Saint Louis Children's Hospital	Saint Louis	Missouri
United States	Saint Louis University School of Medicine	Saint Louis	Missouri
United States	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	Rady Children's Hospital-San Diego	San Diego	California
United States	University of California at San Francisco Medical Center	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Baystate Medical Center, High Street Health Center	Springfield	Massachusetts
United States	Pediatric Specialty Center at Saint Barnabas	West Orange	New Jersey

Sponsors (9)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months after baseline

External Links

•   Click here for more information on the Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry