Clinical Trial: Start Time Optimization of Biologics in Polyarticular JIA

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Start Time Optimization of Biologics in Polyarticular JIA

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.

Detailed Summary:

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 patie
Sponsor: Hackensack University Medical Center

Current Primary Outcome: 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


Original Primary Outcome: Clinical inactive disease (CID) [ Time Frame: 12 months ]

We will compare achievement of CID between the groups started on the 3 CTPs


Current Secondary Outcome: 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


Original Secondary Outcome: Patient and caregiver reported outcomes [ Time Frame: 12 months ]

We will compare patient and caregiver reported outcomes between the groups started on the 3 CTPs


Information By: Hackensack University Medical Center

Dates:
Date Received: October 29, 2015
Date Started: November 2015
Date Completion: September 2018
Last Updated: May 12, 2017
Last Verified: May 2017