None listed
Conditions
Interventions
Celecoxib suspension Type of group
Dosage of celecoxib in patients with JRA is extrapolated from the dose of celecoxib recommended in adult RA expressed on a mg / kg basis.
Group name:naproxen suspension Type of group
The dosage of naproxen (7.5 mg / kg BID) is based on recommendations from the community of pediatric rheumatology which recommends a therapeutic range of 10-20 mg / kg / day.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has a diagnosis of JRA of a polyarticular or oligoarticular course determined according to the CAR criteria. Patients with systemic onset JRA who have a polyarticular or oligoarticular course are eligible. Patients with Active systemic characteristics will not be included. 2. The patient is at least two years old and has not yet reached his 17th birthday. 3. The patient must weigh at least 15 kg. 4. The patient must have> 1 swollen joint and> 1 joint with limitation of the movement. Joints with limited range of movements can be the same as the swollen joints. 5. Must have rm CESN score of> 0.2. 6. Must have a global evaluation by the physician and the father in the selection of> 20 mm on a 100 mm EVA scale.
Exclusion criteria
Exclusion criteria: 1. The patient is in the active phase of systemic JRA. 2. The patient has received or has been exposed to investigational drugs within the specified times before receiving the first dose of the medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1. Overall assessment of the disease activity by the doctor; 2. Evaluation by the Father of the overall evaluation of total well-being; 3. Functional capacity; 4. Number of joints with active arthritis; 5. Number of joints with limitation in the range of movements; Y 6. Inflammation laboratory marker (C-Reactive Protein will be used in this study). Measure:Improvement in the patients arthritic condition defined according to criterion ARJ 30. Timepoints:week 2, 4, 8, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1. Adverse events 2. Values of laboratory tests 3. Measurements of vital signs Measure:Safety evaluation Timepoints:week 2, 4, 8, 12 | — |
Countries
Belgium, Brazil, Canada, Denmark, France, Germany, Norway, Peru, Portugal, Russian Federation, Slovakia, Slovenia, Spain, Sweden, United States
Outcome results
None listed