Start Time Optimization of Biologics in Polyarticular JIA
Completed
Conditions studied: Polyarticular Juvenile Rheumatoid Arthritis, Arthritis, Juvenile Idiopathic
In brief
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.
Key facts
- Study ID
- NCT02593006
- Run by
- Hackensack Meridian Health
- People needed
- 400
- Starts
- 2015-11-01
- Expected to finish
- 2019-09-30
- Last updated by the study team
- 2021-02-05
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States
- Rady Children's Hospital-San Diego — San Diego, California, United States
- University of California at San Francisco Medical Center — San Francisco, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- University of Florida Shand's Children's Hospital — Gainesville, Florida, United States
- Emory Children's Center — Atlanta, Georgia, United States
- Georgia Regents University Medical Center — Augusta, Georgia, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Indiana University School of Medicine — Indianapolis, Indiana, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Louisville School of Medicine — Louisville, Kentucky, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Baystate Medical Center, High Street Health Center — Springfield, Massachusetts, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Saint Louis University School of Medicine — St Louis, Missouri, United States
- Saint Louis Children's Hospital — St Louis, Missouri, United States
- HackensackUniversity Medical Center — Hackensack, New Jersey, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.