Table 1.
Summary of randomized clinical trials included in the analysis
| Phase | ClinicalTrials.gov identifier | Protocol number/ trial name |
Patients included in current analysis, n | Patient population | Tofacitinib dose included in analysis | Study duration |
|---|---|---|---|---|---|---|
| 2 | NCT00147498 [19] | A3921019 | 61 | Active RA with inadequate response to, or discontinued therapy due to unacceptable toxicity from, MTX, etanercept, infliximab, or adalimumab | 5 mg BID (monotherapy) | 6 weeks |
| NCT00413660 [20] | A3921025 | 145 | Active RA with inadequate response to stably dosed MTX | 5 and 10 mg BID (with background MTX) | 24 weeks | |
| NCT00550446 [21] | A3921035 | 110 | Active RA with inadequate response to ≥ 1 DMARD | 5 and 10 mg BID (monotherapy) | 24 weeks | |
| NCT00603512 [22] | A3921039 | 53 | Active RA with inadequate response to stably dosed MTX | 5 and 10 mg BID (with background MTX) | 12 weeks | |
| NCT00687193 [23] | A3921040 | 105 | Active RA with inadequate response to ≥ 1 DMARD | 5 and 10 mg BID (monotherapy) | 12 weeks | |
| NCT01164579 [24] | A3921068 | 72 | Early, active RA and MTX- and bDMARD-naïve | 10 mg BID (with or without background MTX) | 12 months | |
| NCT00976599 [25] | A3921073 | 15 | Active RA with inadequate response to stably dosed MTX | 10 mg BID (with background MTX) | 4 weeks | |
| NCT01059864 [26] | A3921109 | 111 | Active RA | 10 mg BID (monotherapy) | 12 weeks | |
| NCT01359150 [27] | A3921129 | 112 | Active RA | 10 mg BID (with or without background MTX) | 9 weeks | |
| NCT02147587 [28] | A3921237 | 55 | Active RA with inadequate response to stably dosed MTX | 5 mg BID (with background MTX) | 14 weeks | |
| 3 | NCT00960440 [29] |
A3921032/ ORAL Step |
267 | Active RA with inadequate response to TNFi | 5 and 10 mg BID (with background MTX) | 6 months |
| NCT00847613 [30] |
A3921044/ ORAL Scan |
637 | Active RA with inadequate response to stably dosed MTX | 5 and 10 mg BID (with background MTX) | 24 months | |
| NCT00814307 [31] |
A3921045/ ORAL Solo |
488 | Active RA with inadequate response to ≥ 1 DMARD | 5 and 10 mg BID (monotherapy) | 6 months | |
| NCT00856544 [32] |
A3921046/ ORAL Sync |
633 | Active RA with inadequate response to ≥ 1 DMARD | 5 and 10 mg BID (with background DMARD) | 12 months | |
| NCT00853385 [33] |
A3921064/ ORAL Standard |
405 | Active RA with inadequate response to stably dosed MTX | 5 and 10 mg BID (with background MTX) | 12 months | |
| NCT01039688 [34] |
A3921069/ ORAL Start |
770 | Active RA and MTX-naïve | 5 and 10 mg BID (monotherapy) | 24 months | |
| 3b/4 | NCT02187055 [35] |
A3921187/ ORAL Strategy |
760 | Active RA with inadequate response to stably dosed MTX | 5 mg BID (with or without background MTX) | 12 months |
| NCT02831855 [36] |
A3921192/ ORAL Shift |
694 | Active RA with inadequate response to stably dosed MTX | 11 mg QD (with or without background MTX) | 12 months | |
| NCT02092467 [37] |
A3921133/ ORAL Surveillance |
2911 | Active RA with inadequate response to stably dosed MTX | 5 and 10 mg BID (with background MTX) | Up to 72 months |
bDMARD biologic disease-modifying antirheumatic drug, BID twice daily, DMARD disease-modifying antirheumatic drug, MTX methotrexate, QD once daily, RA rheumatoid arthritis, TNFi tumor necrosis factor inhibitor