Methods |
Allocation: randomized
Blinding: double blind for tablet therapy but not injections. Blind assessments.
Design: parallel study, 3 groups
Sample size at entry 90: Auranofin 30; placebo 30, GSTM 30.
Analysis: completers |
Participants |
Country: UK
Patients with active RA
Age: median 52.17 yrs (sd 16.7)
Duration of disease: median 5 yrs (sd 13.00)
Females: 69%
RF: 88.9%
Concomitant use of steriods: none
Concomitant use of DMARDS: none
Previous of DMARDS: not in past 6 mo. |
Interventions |
Auranofin 6mg/day or matching placebo or GSTM 50 mg IM/wk
Treatment duration: 6 mos |
Outcomes |
ESR
Disease activity index (combining other measures) |
Notes |
Quality score: 4
Allocation concealment: unclear
Except for ESR no OMERACT end of trial results reported
Six outcome measures were combined to derive a disease activity index.
Reported ESR changes, imputed baseline SD to end of trial
Withdrawals and dropouts reported @ 24 wks. ADRs not requiring withdrawal not reported. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |