Table 1

 Baseline characteristics (before entry to the first open label phase) of 969 patients and a comparison of all patients with the patients continuing to the second open phase (n = 672) and those entering the double blind phase (n = 106)

CharacteristicsFirst open label phaseSecond open label phaseSecond double blind phase
Leflunomide (n = 969)Leflunomide (n = 672)Leflunomide + sulfasalazine (n = 56)Placebo + sulfasalazine (n = 50)
Mean age (years)55.054.856.355.4
Female, No (%)722 (74.5)503 (74.9)37 (66.1)37 (74.0)
Disease duration:
    Mean (years)
    Diagnosed >2 years (%)61.463.555.454.0
Disease activity:
    ARA functional class I (%)12.312.9 137.110.0
    ARA functional class II/III (%)87.787.192.990.0
    Low activity
    Moderate activity13.513.712.510.2
    High activity86.586.387.592.0
    Mean DAS28 score6.
Rheumatoid factor positive (%)82.782.177.878.0
Pharmacological treatment:
    Previous DMARD treatment (%)72.173.566.168.0
    Mean number of previous DMARDs1.