|
| Study | Phase | Duration | Participants | Intervention | Primary Outcome |
|
| Burmester et al. [15] | 3 | 6 months | Moderate to severe RA Patients with inadequate response to TNFα inhibitors () | Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo all with methotrexate | ACR 20 response at month 3;
DAS 28-4 ESR < 2.6 at month 3;
HAQ-DI at month 3 (change from baseline) |
|
| Fleischmann et al. [16] | 3 | 6 months | Active RA patients receiving stable doses of antimalarial agents
Prior inadequate response to at least one DMARD (biologic or nonbiologic) () | Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo for 3 months followed by Tofacitinib 5 mg bd;
placebo for 3 months followed by Tofacitinib 10 mg bd | ACR 20 response at month 3;
DAS 28-4 ESR < 2.6 at month 3;
HAQ-DI at month 3 (change from baseline) |
|
| Kremer et al. [17] | 3 | 12 months | Active RA Patients with inadequate response to ≥1 DMARD () | Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo | ACR 20 response at month 6;
DAS 28-4 ESR < 2.6 at month 6;
HAQ-DI at month 3 (change from baseline) |
|
| van der Heijde et al. [18] | 3 | 24 months | Active RA patients receiving background methotrexate () | Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo followed by Tofacitinib 5 mg bd;
placebo followed by Tofacitinib 10 mg bd | ACR 20 response at month 6;
DAS 28-4 ESR < 2.6 at month 6;
HAQ-DI at month 3 (change from baseline) |
|
| van Vollenhoven et al. [19] | 3 | 12 months | Active RA patients receiving stable doses of methotrexate () | Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
adalimumab 40 mg every 2 weeks;
placebo | ACR 20 response at month 6;
DAS 28-4 ESR < 2.6 at month 6;
HAQ-DI at month 3 (change from baseline) |
|
| Fleischmann et al. [20] | 2b | 24 weeks | Active RA Patients with inadequate response to DMARD () | Tofacitinib 1 mg, 3 mg, 5 mg, 10 mg, or 15 mg bd;
adalimumab 40 mg every 2 weeks for 6 injections followed by Tofacitinib 5 mg bd;
placebo | ACR 20 response at week 12 |
|
| Kremer et al. [21] | 2b | 24 weeks | Active RA patients receiving stable doses of methotrexate with inadequate response to methotrexate alone () | Tofacitinib 20 mg daily;
Tofacitinib 1 mg, 3 mg, 5 mg, 10 mg, or 15 mg bd;
placebo | ACR 20 response at week 12 |
|
| Tanaka et al. [22] | 2 | 12 weeks | Active RA patients receiving stable doses of methotrexate with inadequate response to methotrexate alone () | Tofacitinib 1 mg, 3 mg, 5 mg, and 10 mg bd;
placebo | ACR 20 response at week 12 |
|
| Kremer et al. [23] | 2a | 6 weeks | Active RA Patients with inadequate or toxic response to methotrexate, etanercept, infliximab, or adalimumab () | Tofacitinib 5 mg, 15 mg, and 30 mg bd;
placebo | ACR 20 response at week 6 |
|
| Coombs et al. [24] | 2 | 6 weeks | Moderate to severe active RA Patients with inadequate response to methotrexate or a TNFα inhibitor () | Tofacitinib 5 mg, 15 mg, and 30 mg bd;
placebo | Visual analogue scale scores at week 6;
HAQ-DI (change from baseline) and short form-36 (SF-36) at week 6 |
|
