Ruperto 2005.

Methods	Allocation: randomised Blinding: double‐blind, double‐dummy Controlled: active comparator Centre: multicentre Arm: 3 arms, parallel groups
Participants	Inclusion criteria: diagnosis of JIA (Durban criteria); NSAID therapy is required; have at least 2 joints with active arthritis plus abnormal results in at least 2 of any of the 5 remaining JIA core set criteria Exclusion criteria: current systemic manifestations; abnormal laboratory results unrelated to JIA; pregnancy, breastfeeding; bleeding disorders; peptic ulcer in past 6 months; hypersensitivity to NSAIDs; other rheumatic conditions; other medications related to rheumatic conditions; taking other NSAIDs Baseline characteristics N = 225 Age: 2 to 16 years Gender: male (148); female (67) Number randomised: meloxicam low (73); meloxicam high (74); naproxen (78) Number completed: meloxicam low (58); meloxicam high (63); naproxen (61) Setting and location: 34 paediatric rheumatology tertiary care units in Austria, Belgium, France, Germany, Italy, Russia, and the UK
Interventions	Intervention group 1 (N = 73): meloxicam 0.125 mg/kg, 1 dose per day Intervention group 2 (N = 74): meloxicam 0.25 mg/kg, 1 dose per day Control group (N = 78): naproxen 5 mg/kg, twice per day Placebo 'naproxen' tablets for the meloxicam groups and placebo 'meloxicam' tablets for the naproxen group Study duration: 48 weeks
Outcomes	Primary outcomes At least 30% improvement from baseline (ACR Pediatric 30 criteria) At least 50% improvement from baseline (ACR Pediatric 30 criteria) At least 70% improvement from baseline (ACR Pediatric 30 criteria) Secondary outcomes Number of joints with active arthritis (JIA score set) Number of joints with limited range of motion (0 to 67) Physician's global evaluation of disease activity (double‐anchored 100‐millimetre VAS) Parent's global assessment of the child's overall well‐being (double‐anchored 100‐millimetre VAS) Disability index (CHAQ) Western ESR Parent's evaluation of the child's pain (double‐anchored 100‐millimetre VAS) Parent's evaluation of the child's arthritis (double‐anchored 100‐millimetre VAS) Child's assessment of discomfort by facial affective scale (1 to 9 points)
Notes	Sources of funding: grant from Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, to the Paediatric Rheumatology International Trials Organisation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "patients were allocated to 1 of the 3 treatment groups in a 1:1:1 randomization scheme" Comment: Randomisation method not described.
Allocation concealment (selection bias)	Unclear risk	Comment: No description of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "to keep the trial blinded, children in the meloxicam group also received naproxen placebo suspension and vice versa, in a double‐dummy design"
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. Loss to follow‐up and withdrawals explained. However, authors do not report whether there were significant differences between completers and non‐completers.
Selective reporting (reporting bias)	Low risk	Comment: All planned outcomes from the methods were reported in the results.
Size	Unclear risk	Comment: Total participants = 225 (between 50 and 200 per treatment arm)
Other bias	Low risk	Comment: No other potential sources of bias found.

ACR: American College of Rheumatology; CHAQ: Child Health Assessment Questionnaire; ESR: erythrocyte sedimentation rate;JIA: juvenile idiopathic arthritis; JRA: juvenile rheumatoid arthritis; VAS: visual analogue scale.