Reiff 2006.

Methods	Allocation: randomised Blinding: double‐blind, double‐dummy Controlled: active comparator Centre: multicentre Arm: 2 arms, parallel groups
Participants	Inclusion criteria: children with pauci‐ (oligo) or polyarticular course JRA for ≥ 3 months meeting the ACR criteria for juvenile rheumatoid arthritis. Must have patient assessment of overall well‐being (0‐to‐100 VAS) of > 90 with at least 1 swollen joint. Exclusion criteria: active systemic JRA symptoms within 3 months of randomisation or if they were not within the 5th to 95th percentile of weight for height; hypersensitivity to aspirin and/or an NSAID; unstable antirheumatic medication regimens; requiring alkylating agents, anticonvulsants, warfarin, or rifampicin; female patients who had reached menarche were required to be in a non‐gravid state as determined by measurement of serum beta‐human chorionic gonadotropin. Baseline characteristics N = 310 Age: 2 to 17 years; mean 9.9 years Gender: male (83); female (227) Number randomised: intervention A (109); intervention B (100); control (101) Number completed: intervention A (99); intervention B (95); control (91) Setting and location: 41 clinical centres in Australia, Europe, Asia, Central America, South America, USA
Interventions	Intervention group (N = 209): (children) low‐dose rofecoxib 0.3 mg/kg/day maximum 12.5 mg/day, or high‐dose rofecoxib 0.6 mg/kg/day maximum 25 mg/day; (adolescents) rofecoxib 12.5 or 25 mg daily Control group (N = 101): (children) naproxen 15 mg/kg/day 5 mg oral suspension; (adolescents) 15 mg/kg/day maximum 1000 mg/day Study duration: 12 weeks (+ 52‐week open‐label extension)
Outcomes	Primary outcomes Time‐weighted average proportion of patients achieving ACR Pediatric 30 (at least 30% improvement in any 3 of 6 variables Investigators' global assessment of disease activity (100‐millimetre VAS) Parent/patient's global assessment of overall well‐being (100‐millimetre VAS) Measure of physical functional ability (CHAQ: 0‐to‐3‐point scale) Number of joints with active arthritis Number of joints with limited range of motion Measure of inflammation (ESR) Secondary outcomes Proportion of patients showing improvement from baseline using (b) above Safety assessments ‐ adverse events Serious adverse events
Notes	Sources of funding: unstated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomisation to treatment groups in equal proportions was performed using a computer‐generated allocation schedule. Treatment assignment was stratified based on joint involvement (pauci‐ or polyarticular course) and age group (2‐11 years or 12‐17 years)."
Allocation concealment (selection bias)	Low risk	Quote: "randomisation to treatment groups in equal proportions was performed using a computer‐generated allocation schedule. Treatment assignment was stratified based on joint involvement (pauci‐ or polyarticular course) and age group (2‐11 years or 12‐17 years)."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "to maintain blinding to treatment assignment during the base study, each patient received 2 coded test products ‐ active or identical‐appearing placebo"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Insufficient information
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All participants were accounted for. Lost to follow‐up and withdrawals explained.
Selective reporting (reporting bias)	Low risk	Comment: All planned outcomes from the methods section were reported in the results.
Size	Unclear risk	Comment: Total participants = 310 (between 50 and 200 per treatment arm)
Other bias	Low risk	Comment: No other potential sources of bias found.