Start Time Optimization of Biologics in Polyarticular JIA (STOP-JIA)
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| ClinicalTrials.gov Identifier: NCT02593006 |
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Recruitment Status :
Completed
First Posted : October 30, 2015
Results First Posted : February 5, 2021
Last Update Posted : February 5, 2021
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| Condition or disease |
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| 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 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 Type : | Observational |
| Actual Enrollment : | 400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Start Time Optimization of Biologics in Polyarticular JIA |
| Study Start Date : | November 2015 |
| Actual Primary Completion Date : | September 30, 2019 |
| Actual Study Completion Date : | September 30, 2019 |
- 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.
- Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups [ Time Frame: 12 months after baseline ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
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Prior treatments permitted:
- NSAIDS
- Hydroxychloroquine
- Intraocular / topical / intraarticular glucocorticoids
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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
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
| Principal Investigator: | Yukiko Kimura, MD | Hackensack Meridian Health | |
| Principal Investigator: | Sarah Ringold, MD | Seattle Children's Hospital |
Documents provided by Hackensack Meridian Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hackensack Meridian Health |
| ClinicalTrials.gov Identifier: | NCT02593006 |
| Other Study ID Numbers: |
Pro5835 |
| First Posted: | October 30, 2015 Key Record Dates |
| Results First Posted: | February 5, 2021 |
| Last Update Posted: | February 5, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | IPD will be available for requests through the CARRA data and sample request portal once the PCORI Final Research Report has been approved and is publicly available. There is no time limit. |
| Access Criteria: | Investigators may request data through the CARRA data and sample share request portal. Inquiries may be sent to research@carragroup.org. |
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Joint Diseases Juvenile Arthritis treatment biologic therapy comparative effectiveness |
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Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |