drugset / Trial / NCT01015547
Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis
Phase 3
Completed
60 enrolled
Helsinki University Central Hospital
Foundation for Paediatric Research, Finland · collabPaijat-Hame Hospital District · collabPäivikki and Sakari Sohlberg Foundation, Finland · collabRheumatism Foundation Hospital · collabScandinavian Rheumatology Research Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (DMARDs), and methotrexate alone.
Timeline
- Start
- 2003-05
- Primary completion
- 2007-11
- Completion
- 2013-12
Publications
- Background Lahdenne P, Vahasalo P, Honkanen V. Infliximab or etanercept in the treatment of children with refractory juvenile idiopathic arthritis: an open label study. Ann Rheum Dis. 2003 Mar;62(3):245-7. doi: 10.1136/ard.62.3.245.
- Results Tynjala P, Vahasalo P, Tarkiainen M, Kroger L, Aalto K, Malin M, Putto-Laurila A, Honkanen V, Lahdenne P. Aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis (ACUTE-JIA): a multicentre randomised open-label clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1605-12. doi: 10.1136/ard.2010.143347. Epub 2011 May 28.
- Tarkiainen M, Tynjala P, Vahasalo P, Aalto K, Kroger L, Rebane K, Lahdenne P, Martikainen J. Economic evaluation of infliximab, synthetic triple therapy and methotrexate in the treatment of newly diagnosed juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2022 Nov 16;20(1):97. doi: 10.1186/s12969-022-00748-w.
- Tarkiainen M, Tynjala P, Vahasalo P, Kroger L, Aalto K, Lahdenne P. Health-related quality of life during early aggressive treatment in patients with polyarticular juvenile idiopathic arthritis: results from randomized controlled trial. Pediatr Rheumatol Online J. 2019 Dec 16;17(1):80. doi: 10.1186/s12969-019-0370-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Methotrexate | Small molecule | 15 mg/m2 | Oral |
| Subject | Methotrexate | Small molecule | 30 mg/m2 | Oral |
| Subject | Sulfasalazine | Small molecule | 40 mg/kg | — |