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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 26 October 2015
Main ID:  NCT01015547
Date of registration: 17/11/2009
Prospective Registration: No
Primary sponsor: Helsinki University Central Hospital
Public title: Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis ACUTE-JIA
Scientific title: Comparison of Anti-TNF Therapy Plus Methotrexate, Combination Therapy of DMARDs, and Methotrexate Alone in Very Early Polyarticular Juvenile Idiopathic Arthritis. A National Randomized Multicenter Clinical Trial.
Date of first enrolment: May 2003
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01015547
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Finland
Contacts
Name:     Pekka Lahdenne, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Hospital for Children and Adolescents in Helsinki University Central Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- juvenile idiopathic arthritis

- arthritis lasting for at least 6 weeks but not more than 6 months

- polyarticular disease with at least 5 active joints with at least 3 joints with pain
or tenderness and limitation of motion

- no previous treatment with DMARDs

Exclusion Criteria:

- systemic JIA

- any abnormality in the hematopoietic or lymphatic system

- any major concurrent medical condition

- inadequate psychosocial situation

- pregnancy

- a non-abstinent female with reproductive capacity without regular contraceptive use



Age minimum: 4 Years
Age maximum: 15 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Juvenile Idiopathic Arthritis
Intervention(s)
Drug: Infliximab plus methotrexate
Drug: Combination of DMARDs
Drug: Methotrexate alone
Primary Outcome(s)
ACR Pedi 75 response [Time Frame: 54 weeks from baseline (0)]
Secondary Outcome(s)
time spent in ACR Pedi 75 [Time Frame: 0 to 54 weeks]
drug survival [Time Frame: 54 weeks]
clinically inactive disease [Time Frame: at 54 weeks]
cost-benefit ratio in each treatment arm [Time Frame: 0 to 54 weeks]
occurrence of side-effects and adverse events [Time Frame: 0 to 54 weeks]
Other ACR Pedi responses (30, 50, 70, 90, 100) [Time Frame: 0 to 54 weeks]
time spent in inactive disease [Time Frame: 0 to 54 weeks]
Secondary ID(s)
211864, 318/E0/2002
211864
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Scandinavian Rheumatology Research Foundation
Foundation for Paediatric Research, Finland
Paijat-Hame Hospital District
Päivikki and Sakari Sohlberg Foundation, Finland
Rheumatism Foundation Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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