Skip to main content

Table 1 Summary of the randomized controlled trials (RCTs) included in this meta-analysis

From: Efficacy, safety and tolerability of tofacitinib in patients with an inadequate response to disease modifying anti-rheumatic drugs: a meta-analysis of randomized double-blind controlled studies

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)

  1. N = Sample size.