Foeldvari 2009.
| Methods | Allocation: randomised Blinding: double‐blind Controlled: active comparator Centre: multicentre Arm: 2 arms, parallel groups | |
| 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 | |
| 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 | |
| Outcomes | Primary outcomes 
 Secondary outcomes 
 | |
| 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. |