Goodkin 1991

Methods	Allocation: randomised; random number tables used ‐ no further information. Blindness: double. Design: parallel group. Intention to treat not done. Duration: 2 years treatment/follow‐up.
Participants	Diagnosis: RRMS N= 59 (100%) N= 54 (azathioprine 29; placebo 25). N= 52 (96%) included in analysis (azathioprine 27; placebo 25). Sex: 40 females,19 males. Age at onset: mean 30 years. Disease duration: mean 6 years. EDSS: mean 3.2 (1.2) (azathioprine); mean 3.7 (1.6) (placebo). Exclusion criteria: immunosuppressive therapy for 1 year prior to the study, total lymphoid irradiation at any time. Pregnancy, unwilling to practice birth control, systemic ilnesses, unable to give informed consent. USA 1 centre.
Interventions	1. Azathioprine 3 mg/kg/daily 2. Placebo
Outcomes	Primary outcomes: mean relapse rate at 1 and 2 years. Mean change in EDSS score at 2 years. Secondary outcomes: time to first relapse, percentage of patients with at least one relapse at 1, 2 years, time to EDSS deterioration sustained for > 2 months, change in mean ambulation index score, time to deterioration of at least 1 point on ambulation index score > 2 months, time to deterioration of 20% or more in baseline nine‐hole‐peg test (9HPT) or in box‐and‐block test (BBT) for > 2 months, percentage of groups experiencing such deterioration in 9HPT or BBT, patient's subjective assessment of treatment, examining physician's assessment. * EDSS deterioration: worseniing of 0.5 or more if EDSS at entry > 5; of 1 or more if baseline EDSS < 5.5.
Notes	7 (12%) people were lost to 2 years follow‐up (3 azathioprine, 4 placebo); reasons ‐ 4 persons (1 azathioprine, 3 placebo) denied entry; 1 person (placebo) developed severe relapse before entry; 1 person (azathioprine) refused follow‐up; and 1 person (azathioprine) was a protocol breach. People who did not enter the study or who dropped‐out were not included in analysis. Blinding: at the end of follow‐up, 56% of patients and 85% of the psysicians did not guess therapy. Supported by National Multiple Sclerosis Society. Drugs supplied by Wellcome Company. Recruitment period: 1983 to 1989.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear