N/A
Completed N=400
Start Time Optimization of Biologics in Polyarticular JIA
Polyarticular Juvenile Rheumatoid Arthritis · Arthritis, Juvenile Idiopathic
Source: ClinicalTrials.gov NCT02593006 ↗
Enrolled (actual)
400
Serious AEs
5.0%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids — 32.3; 37.2; 24.2 percentage of participants achieving CID — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinically Inactive Disease (CID) Off Glucocorticoids |
32.3; 37.2; 24.2 | >0.05 |
| SECONDARY Comparison of PROMIS Pain and Mobility Scores Between the 3 Consensus Treatment Plan Groups |
53.1; 55.5; 55.9; 38.6; 35.8; 37.5 | 0.04 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02593006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.