Time from enrolment | MTX +prednisolone group | Placebo +prednisolone group | ||
Week | Methotrexate (mg/week) (MTX tablets will be 2.5âmg) | Prednisolone (mg/day) | Prednisolone (mg/day) | Dummy methotrexate (number of tablets/week) |
0 | 10 | 40 | 40 | 4 |
1â7 | 15 | 40 | 40 | 6 |
2 | 15 | 35 | 35 | 6 |
3 | 15 | 35 | 35 | 6 |
4 | 15 | 30 | 30 | 6 |
5 | 15 | 30 | 30 | 6 |
6 | 15 | 25 | 25 | 6 |
7 | 15 | 25 | 25 | 6 |
8 | 15/20 | 20 | 20 | 6/8 |
9 | 15/20 | 20 | 20 | 6/8 |
10 | 15/20 | 20 | 20 | 6/8 |
11 | 15/20 | 20 | 20 | 6/8 |
12 | 15/20 | 15 | 15 | 6/8 |
13 | 15/20 | 15 | 15 | 6/8 |
14 | 15/20 | 15 | 15 | 6/8 |
15 | 15/20 | 15 | 15 | 6/8 |
16 | 15/20 | 10 | 10 | 6/8 |
17 | 15/20 | 10 | 10 | 6/8 |
18 | 15/20 | 5 | 5 | 6/8 |
19 | 15/20 | 5 | 5 | 6/8 |
20â47 | 15/20 | 0 | 0 | 6/8 |
48 | 10 | 0 | 0 | 4 |
49 | 10 | 0 | 0 | 4 |
50 | 5 | 0 | 0 | 2 |
51 | 5 | 0 | 0 | 2 |
52â59 | 0 | 0 | 0 | 0 |
Participants weighing less than 60 kg will continue to receive 15 mg of MTX weekly and individuals weighing 60 kg or more will receive MTX 20 mg from week 8.
ENL, erythema nodosum leprosum; MaPs, methotrexate and prednisolone study; MTX, methotrexate.