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

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ClinicalTrials.gov Identifier: NCT02593006
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : September 5, 2018
Sponsor:
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
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
STOP-JIA is a PCORI funded prospective observational study which will compare 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.

Condition or disease
Polyarticular Juvenile Rheumatoid Arthritis Arthritis, Juvenile Idiopathic

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 is >400, or 200 patients per year over 2 years of recruitment.

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 will use 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
Actual Enrollment : 403 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Start Time Optimization of Biologics in Polyarticular JIA
Study Start Date : November 2015
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019





Primary Outcome Measures :
  1. Clinical inactive disease (CID) [ Time Frame: 12 months ]
    We will use the American College of Rheumatology criteria for CID to compare achievement of CID between the groups started on the 3 CTPs


Secondary Outcome Measures :
  1. Patient and caregiver reported outcomes [ Time Frame: 12 months ]
    We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups started on the 3 CTPs



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with new onset, untreated Poly JIA enrolled in the CARRA Registry.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593006


  Show 55 Study Locations
Sponsors and Collaborators
Hackensack Meridian Health
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
Investigators
Principal Investigator: Yukiko Kimura, MD Hackensack Meridian Health
Principal Investigator: Sarah Ringold, MD Seattle Children's Hospital

Additional Information:
Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02593006     History of Changes
Other Study ID Numbers: Pro5835
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Hackensack Meridian Health:
Joint Diseases
Juvenile Arthritis
treatment
biologic therapy
comparative effectiveness

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases