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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 October 2015 |
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Main ID: |
NCT01015547 |
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Date of registration:
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17/11/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis
ACUTE-JIA |
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Scientific title:
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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. |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01015547 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Finland
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Contacts
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Name:
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Pekka Lahdenne, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital for Children and Adolescents in Helsinki University Central Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Juvenile Idiopathic Arthritis
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Intervention(s)
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Drug: Infliximab plus methotrexate
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Drug: Combination of DMARDs
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Drug: Methotrexate alone
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Primary Outcome(s)
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ACR Pedi 75 response
[Time Frame: 54 weeks from baseline (0)]
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Secondary Outcome(s)
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time spent in ACR Pedi 75
[Time Frame: 0 to 54 weeks]
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cost-benefit ratio in each treatment arm
[Time Frame: 0 to 54 weeks]
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occurrence of side-effects and adverse events
[Time Frame: 0 to 54 weeks]
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drug survival
[Time Frame: 54 weeks]
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Other ACR Pedi responses (30, 50, 70, 90, 100)
[Time Frame: 0 to 54 weeks]
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time spent in inactive disease
[Time Frame: 0 to 54 weeks]
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clinically inactive disease
[Time Frame: at 54 weeks]
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Secondary ID(s)
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211864, 318/E0/2002
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211864
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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