Foeldvari 2009.
Methods |
Allocation: randomised Blinding: double‐blind Controlled: active comparator Centre: multicentre Arm: 2 arms, parallel groups |
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Participants |
Inclusion criteria: children ≥ 9 kg, with pauciarticular of polyarticular course JRA, with or without systemic onset, according to ACR criteria; > 1 swollen joint with limited motion; parent global assessment ≥ 10 mm (100‐millimetre VAS) Exclusion criteria: active systemic manifestations; oral corticosteroid doses ≤ 0.2 mg/kg/day or 10 mg prednisone or methotrexate < 1 mg/kg/week Baseline characteristics N = 242 Age: 2 to 16 years Gender: male (71); female (171) Number randomised: intervention A (77); intervention B (82); control (83) Number completed: intervention A (67); intervention B (71); control (74) Setting and location: 17 centres worldwide |
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Interventions |
Intervention group (N = 77): celecoxib 50 mg/5 mL oral suspension (target dose approximately 3 mg/kg twice daily) Intervention group (N = 82): celecoxib 100 mg/5 mL oral suspension (target dose approximately 6 mg/kg twice daily) Control group (N = 83): naproxen 125 mg/5 mL oral suspension (target dose approximately 7.5 mg/kg twice daily) Study duration: 12 weeks |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | Sources of funding: editorial support funded by Pfizer | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "children were randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio ... randomized according to the allocation number provided by an interactive voice response system" |
Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Insufficient information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Insufficient information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: All participants were accounted for. Lost 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) | High risk | Comment: Secondary outcome data not reported (e.g. Pediatric Quality of Life Inventory) |
Size | Unclear risk | Comment: Total participants = 242 (between 50 and 200 per treatment arm) |
Other bias | Low risk | Comment: No other potential sources of bias found. |