Determining Predictors of Safe Discontinuation of Anti-TNF Treatment in JIA

Completed · Phase 4

Conditions studied: Juvenile Idiopathic Arthritis

In brief

Polyarticular juvenile idiopathic arthritis (Poly JIA) is a form of juvenile arthritis, which is a chronic disease affecting approximately 250,000 people younger than 16 years of age. Poly JIA can be treated with anti-tumor necrosis factor (anti-TNF), a type of medication that is often effective but also has some toxic side effects and is expensive. Among those with poly JIA who are effectively treated with anti-TNF, some can remain healthy off the medication, but some begin to feel the effects of their disease again once the medication is stopped. This study will attempt to find whether certain tests or signs can predict which people with poly JIA can safely stop their anti-TNF medications.

Key facts

Study ID

NCT00792233

Run by

Children's Hospital Medical Center, Cincinnati

People needed

137

Starts

2009-06-01

Expected to finish

2015-10-01

Last updated by the study team

2016-04-15

Who can join

Age: 4 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of polyarticular JIA (rheumatoid factor + and rheumatoid factor -) or extended oligo JIA by the International League of Associations for Rheumatology (ILAR) criteria
• Receiving therapy with one of the currently available anti-TNF biologics: infliximab, etanercept, or adalimumab
• Absence of any of the FDA label exclusions for anti-TNF therapy
• Receiving slit lamp exams performed at regular intervals in accordance with the published American Academy of Pediatrics guidelines
• Baseline hemoglobin >10 g/dl
• Absence of joints with active arthritis, using the American College of Rheumatology (ACR) definition of "active joint"
• Absence of fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA
• Absence of active uveitis, as per an exam by an ophthalmologist
• Normal erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP); if above normal range, must be not attributable to JIA
• Physician's global assessment of disease activity indicating absence of disease activity, defined as the best score obtainable on the scale used
• Duration of morning stiffness less than or equal to 15 minutes

You may not qualify if…

• Diagnosis of a type of JIA other than polyarticular JIA
• Diagnosis of another inflammatory disease that may affect laboratory results or ability to discontinue anti-TNF biologic therapy
• Concurrent treatment with any biologic agent other than infliximab, etanercept, or adalimumab
• previous treatment with rituximab
• concurrent treatment for JIA with corticosteroids >0.2 mg/kg/day OR >10 mg/day

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Comer Children's Hospital University of Chicago — Chicago, Illinois, United States
• University of Louisville Research Foundation — Louisville, Kentucky, United States
• Joseph M Sanzari Children's Hospital — Hackensack, New Jersey, United States
• Cohen Children's Medical Center of NY — New Hyde Park, New York, United States
• Children's Hospital at Montefiore — The Bronx, New York, United States
• Cincinnati Children's Hospital and Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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