Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)
2 other identifiers
interventional
85
1 country
15
Brief Summary
The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.
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 May 2007
Longer than P75 for phase_4
15 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
March 2, 2007
CompletedFirst Posted
Study publicly available on registry
March 6, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
May 31, 2013
CompletedMay 31, 2013
May 1, 2013
3.4 years
March 2, 2007
March 13, 2013
May 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Who Attain Inactive Disease by 6 Months
6 months after initiation of study intervention
Secondary Outcomes (2)
Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
Over 12 months maximum study participation per subject
Clinical Remission on Medication
12 months or end of study
Study Arms (2)
Methotrexate Arm
ACTIVE COMPARATORMethotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
Methotrexate-Etanercept-Prednisolone Arm
ACTIVE COMPARATORMethotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
Interventions
Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone
methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
- Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
- Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
- Parent or guardian willing to provide informed consent
- Able to attend all study visits
You may not qualify if:
- Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:
- Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
- Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
- Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
- History of or active cancer of any type
- Active gastrointestinal disease (e.g., inflammatory bowel disease)
- Chronic or acute kidney or liver disorder
- Significant blood clotting defect
- AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
- Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
- Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
- Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
- HIV infected
- Known past or current hepatitis infection
- Received a live virus vaccine within 1 month prior to baseline
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)collaborator
- Amgencollaborator
Study Sites (15)
Stanford University Medical Center
Palo Alto, California, 94305, United States
Rady Children's Hospital
San Diego, California, 92123-4282, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Children's Hospital of Boston
Boston, Massachusetts, 02115, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Children's Hospital of Columbus
Columbus, Ohio, 43205, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Texas Scottish Rite Hospital
Dallas, Texas, 75219, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
Related Publications (7)
Lovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. doi: 10.1002/art.21885.
PMID: 16732547BACKGROUNDWallace CA. Current management of juvenile idiopathic arthritis. Best Pract Res Clin Rheumatol. 2006 Apr;20(2):279-300. doi: 10.1016/j.berh.2005.11.008.
PMID: 16546057BACKGROUNDWallace CA, Ruperto N, Giannini E; Childhood Arthritis and Rheumatology Research Alliance; Pediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J Rheumatol. 2004 Nov;31(11):2290-4.
PMID: 15517647BACKGROUNDLim LSH, Lokku A, Pullenayegum E, Ringold S. Probability of Response in the First Sixteen Weeks After Starting Biologics: An Analysis of Juvenile Idiopathic Arthritis Biologics Trials. Arthritis Care Res (Hoboken). 2023 Jun;75(6):1238-1249. doi: 10.1002/acr.25003. Epub 2023 Jan 18.
PMID: 36651601DERIVEDJiang K, Wong L, Sawle AD, Frank MB, Chen Y, Wallace CA, Jarvis JN. Whole blood expression profiling from the TREAT trial: insights for the pathogenesis of polyarticular juvenile idiopathic arthritis. Arthritis Res Ther. 2016 Jul 7;18(1):157. doi: 10.1186/s13075-016-1059-1.
PMID: 27388672DERIVEDWallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS, Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic DS, Punaro MG, Chira P, Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Johnson A, Huang B, Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance (CARRA). Clinically inactive disease in a cohort of children with new-onset polyarticular juvenile idiopathic arthritis treated with early aggressive therapy: time to achievement, total duration, and predictors. J Rheumatol. 2014 Jun;41(6):1163-70. doi: 10.3899/jrheum.131503. Epub 2014 May 1.
PMID: 24786928DERIVEDWallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS, Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic D, Punaro MG, Chira P, Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Hamilton S, Johnson A, Huang B, Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance. Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis. Arthritis Rheum. 2012 Jun;64(6):2012-21. doi: 10.1002/art.34343. Epub 2011 Dec 19.
PMID: 22183975DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
small number of participants with recent onset poly JIA
Results Point of Contact
- Title
- Carol Wallace, MD Principal Investigator
- Organization
- University of Washington and Seattle Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Carol A. Wallace, MD
Childrens Hospital and Regional Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 2, 2007
First Posted
March 6, 2007
Study Start
May 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
May 31, 2013
Results First Posted
May 31, 2013
Record last verified: 2013-05