Start Time Optimization of Biologics in Polyarticular JIA (STOP-JIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02593006|
Recruitment Status : Recruiting
First Posted : October 30, 2015
Last Update Posted : May 15, 2017
|Condition or disease|
|Polyarticular Juvenile Rheumatoid Arthritis Arthritis, Juvenile Idiopathic|
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|
|Estimated Enrollment :||400 participants|
|Official Title:||Start Time Optimization of Biologics in Polyarticular JIA|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593006
|Contact: Mary Ellen Riordan, BSNemail@example.com|
|Contact: Anne Dennosfirstname.lastname@example.org|
Show 53 Study Locations
|Principal Investigator:||Yukiko Kimura, MD||Hackensack University Medical Center|
|Principal Investigator:||Sarah Ringold, MD||Seattle Children's Hospital|