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)
| Characteristics | First open label phase | Second open label phase | Second double blind phase | |
|---|---|---|---|---|
| Leflunomide (n = 969) | Leflunomide (n = 672) | Leflunomide + sulfasalazine (n = 56) | Placebo + sulfasalazine (n = 50) | |
| Mean age (years) | 55.0 | 54.8 | 56.3 | 55.4 |
| Female, No (%) | 722 (74.5) | 503 (74.9) | 37 (66.1) | 37 (74.0) |
| Disease duration: | ||||
| Mean (years) | 7.25 | 7.4 | 6.2 | 6.1 |
| Diagnosed >2 years (%) | 61.4 | 63.5 | 55.4 | 54.0 |
| Disease activity: | ||||
| ARA functional class I (%) | 12.3 | 12.9 13 | 7.1 | 10.0 |
| ARA functional class II/III (%) | 87.7 | 87.1 | 92.9 | 90.0 |
| DAS28 | 0.7 | 12.5 | ||
| Low activity | – | – | – | – |
| Moderate activity | 13.5 | 13.7 | 12.5 | 10.2 |
| High activity | 86.5 | 86.3 | 87.5 | 92.0 |
| Mean DAS28 score | 6.3 | 6.3 | 6.2 | 6.3 |
| Rheumatoid factor positive (%) | 82.7 | 82.1 | 77.8 | 78.0 |
| Pharmacological treatment: | ||||
| Previous DMARD treatment (%) | 72.1 | 73.5 | 66.1 | 68.0 |
| Mean number of previous DMARDs | 1.8 | 1.9 | 1.7 | 1.3 |