| Methods |
Allocation: randomized in blocks of 8 stratified for steroid use.
Blinding: double blind
Design: parallel study
Sample size at entry: 311
Analysis: completers, 97% follow‐up; auranofin 154; placebo 149 |
| Participants |
Country: Canada & US, Multicentre tial (K=14)
Patients with active RA
Age: mean 50.5 yr (SD 11.08)
Duration of disease: mean 8.05 yr (SD 8.0)
Females: 73%
RF: 74%
Concomitant use of steroids: oral 23.5%
Concomitant use of other DMARDS: none
Previous use of DMARDS: not in previous 6 mo. |
| Interventions |
Auranofin 6 (could increase to 9) mg /day vs identical placebo
Treatment duration: 6 months |
| Outcomes |
Tender joint count
Swollen joint count
Pain: 3 scales. Included only 10 cm pain line, 10=severe
Function: 4 scales. Included 2: Health Assessment Questionnaire (0 to 3, 3=worse) and Keitel function test (0‐98, 98=worse)
Patient assessment: 4 scales. Included only 10 cm line, 10 = perfect
Physician assessment: 3 scales. Included only 10 cm line, 10 = perfect
50 ft walk time in seconds (results in text only )
Quality of life: quality of wellbeing scale (results in text only)
ESR |
| Notes |
Quality score: 4
Allocation concealment: adequate
Reported: baseline & SE, mean change scores & SE
Calculated baseline SD values & imputed them to end‐of‐trial results |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
