Table 1.
Author | Year | Phase of the trial | Duration of therapy | Intervention arm-1 | Intervention arm-2 | Intervention arm-3 | Intervention arm-4 | Control arm |
---|---|---|---|---|---|---|---|---|
Kremer JM et al. study 1
[18] |
2012 |
Phase IIb |
24-weeks |
Tofacitinib 3-mg BID + Methotrexate (N = 68) |
Tofacitinib 5-mg BID + Methotrexate (N = 71) |
Tofacitinib 10-mg BID + Methotrexate (N = 74) |
Tofacitinib 15-mg BID + Methotrexate (N = 75) |
Placebo + Methotrexate (N = 69) |
Tanaka Y et al.
[19] |
2011 |
Phase II |
12-weeks |
Tofacitinib 3-mg BID + Methotrexate (28) |
Tofacitinib 5-mg BID + Methotrexate (N = 28) |
Tofacitinib 10-mg BID + Methotrexate (N = 28) |
.. |
Placebo + Methotrexate (N = 28) |
Fleischmann R et al. study 1
[16] |
2012 |
Phase IIb |
24-weeks |
Tofacitinib 3-mg BID (N = 51) |
Tofacitinib 5-mg BID (N = 49) |
Tofacitinib 10-mg BID (N = 61) |
Tofacitinib 15-mg BID (N = 57) |
Placebo (N = 59) |
Fleischmann R et al. study 2
[11] |
2012 |
Phase III |
6-months |
.. |
Tofacitinib 5-mg BID (N = 243) |
Tofacitinib 10-mg BID (N = 245) |
.. |
Placebo (N = 122) |
Kremer JM et al. study 2
[17] |
2009 |
Phase IIa |
12-weeks |
. |
Tofacitinib 5-mg BID (N = 61) |
.. |
Tofacitinib 15-mg BID (N = 69) |
Placebo (N = 65) |
Burmester GR et al.
[10] |
2013 |
Phase III |
6-months |
… |
Tofacitinib 5-mg BID + Methotrexate (N = 133) |
Tofacitinib 10-mg BID + Methotrexate (N = 134) |
.. |
Placebo + Methotrexate (N = 132) |
van der Heijde D et al.
[12] |
2013 |
Phase III |
24-month |
.. |
Tofacitinib 5-mg BID + Methotrexate (N = 321) |
Tofacitinib 10-mg BID + Methotrexate (N = 316) |
.. |
Placebo + Methotrexate (N = 160) |
van Vollenhoven RF et al. [13] | 2012 | Phase III | 12-month | .. | Tofacitinib 5-mg BID + Methotrexate (N = 204) | Tofacitinib 10-mg BID + Methotrexate (N = 201) | .. | Placebo + Methotrexate (N = 108) |
N = Sample size.