Determining Predictors of Safe Discontinuation of Anti-TNF Treatment in JIA
Improved Understanding of the Biology and Use of TNF Inhibition in Children With JIA
2 other identifiers
interventional
137
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2009
Longer than P75 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2008
CompletedFirst Posted
Study publicly available on registry
November 17, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 15, 2016
April 1, 2016
4.3 years
November 14, 2008
April 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease flare, defined as demonstrating at least a 30% worsening in at least 3 of the 6 JIA Core Set parameters with no more than 1 improving by more than 30%
Measured at nine study visits over 14 months
Study Arms (1)
1
EXPERIMENTALParticipants taking anti-TNF medications will be monitored for signs of their disease for 6 months. If, after 6 months, their disease has become inactive, they will stop taking anti-TNF medications for up to 8 months. If participants who are no longer taking anti-TNF medications have a disease flare-up, they will begin treatment again.
Interventions
Anti-TNF therapy will be discontinued at the third visit in children who demonstrate persistent inactive disease for at least 6 months.
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Comer Children's Hospital University of Chicago
Chicago, Illinois, 60637, United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
Joseph M Sanzari Children's Hospital
Hackensack, New Jersey, 07601, United States
Cohen Children's Medical Center of NY
New Hyde Park, New York, 11040, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Hinze CH, Foell D, Johnson AL, Spalding SJ, Gottlieb BS, Morris PW, Kimura Y, Onel K, Li SC, Grom AA, Taylor J, Brunner HI, Huggins JL, Nocton JJ, Haines KA, Edelheit BS, Shishov M, Jung LK, Williams CB, Tesher MS, Costanzo DM, Zemel LS, Dare JA, Passo MH, Ede KC, Olson JC, Cassidy EA, Griffin TA, Wagner-Weiner L, Weiss JE, Vogler LB, Rouster-Stevens KA, Beukelman T, Cron RQ, Kietz D, Schikler K, Mehta J, Ting TV, Verbsky JW, Eberhard AB, Huang B, Giannini EH, Lovell DJ. Serum S100A8/A9 and S100A12 Levels in Children With Polyarticular Forms of Juvenile Idiopathic Arthritis: Relationship to Maintenance of Clinically Inactive Disease During Anti-Tumor Necrosis Factor Therapy and Occurrence of Disease Flare After Discontinuation of Therapy. Arthritis Rheumatol. 2019 Mar;71(3):451-459. doi: 10.1002/art.40727. Epub 2019 Jan 24.
PMID: 30225949DERIVEDLovell DJ, Johnson AL, Huang B, Gottlieb BS, Morris PW, Kimura Y, Onel K, Li SC, Grom AA, Taylor J, Brunner HI, Huggins JL, Nocton JJ, Haines KA, Edelheit BS, Shishov M, Jung LK, Williams CB, Tesher MS, Costanzo DM, Zemel LS, Dare JA, Passo MH, Ede KC, Olson JC, Cassidy EA, Griffin TA, Wagner-Weiner L, Weiss JE, Vogler LB, Rouster-Stevens KA, Beukelman T, Cron RQ, Kietz D, Schikler K, Schmidt KM, Mehta J, Wahezi DM, Ting TV, Verbsky JW, Eberhard BA, Spalding S, Chen C, Giannini EH. Risk, Timing, and Predictors of Disease Flare After Discontinuation of Anti-Tumor Necrosis Factor Therapy in Children With Polyarticular Forms of Juvenile Idiopathic Arthritis With Clinically Inactive Disease. Arthritis Rheumatol. 2018 Sep;70(9):1508-1518. doi: 10.1002/art.40509. Epub 2018 Jul 25.
PMID: 29604189DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J. Lovell, MD
CCHMC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2008
First Posted
November 17, 2008
Study Start
June 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2015
Last Updated
April 15, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share
deidentified subject information and results of testing have already been shared with multiple investigators requesting samples