TABLE 1.
Characteristics of included RCTs.
| Included RCTs | Trial phase | Trial duration | NO. of participants (female/male) | Age (years, mean ± SD) | Study location (number of study sites) | Treatments (participants) |
|---|---|---|---|---|---|---|
| NCT01197521 5 | Phase 3 | 52 weeks | 918 (770/148) | 52 ± 12.0 | Asia, North America, South America, Europe, Oceanica (127) | Fostamatinib 100 mg twice daily (310) |
| Fostamatinib 100 mg twice daily (4 weeks) then 150 mg once daily (304) | ||||||
| placebo (24 weeks) then fostamatinib 100 mg twice daily (304) | ||||||
| NCT01563978 12 | Phase 2 | 4 weeks | 135 (114/21) | 54 ± 12.5 | North America, Europe, Africa (59) | Fostamatinib 100 mg twice daily (68) |
| placebo (67) | ||||||
| NCT01197534 6 | Phase 3 | 52 weeks | 908 (742/166) | 53 ± 11.9 | North America, Europe, Asia, Africa (154) | Fostamatinib 100 mg twice daily (308) |
| Fostamatinib 100 mg twice daily (4 weeks) then 150 mg once daily (298) | ||||||
| placebo (24 weeks) then fostamatinib 100 mg twice daily (302) | ||||||
| NCT01197755 7 | Phase 3 | 24 weeks | 322 (261/61) | 53 ± 12.3 | North America, South America, Europe (136) | Fostamatinib 100 mg twice daily (105) |
| Fostamatinib 100 mg twice daily (4 weeks) then 150 mg once daily (108) | ||||||
| placebo (109) | ||||||
| NCT00665626 3 | Phase 2 | 12 weeks | 219 (176/43) | 56.0 ± 11.7 | North America, Europe, South America (44) | Fostamatinib 100 mg twice daily (146) |
| placebo (73) | ||||||
| NCT01264770 8 | Phase 2b | 24 weeks | 265 (210/55) | 50.0 ± 11.8 | North America, Europe, Africa (109) | Fostamatinib 100 mg twice daily (54) |
| Fostamatinib 100 mg twice daily (4 weeks) then 150 mg once daily (48) | ||||||
| Fostamatinib 100 mg twice daily (4 weeks) then 100 mg once daily (57) | ||||||
| Adalimumab 40 mg every 2 weeks (54) | ||||||
| placebo (6 weeks) then fostamatinib 100 mg twice daily (27) | ||||||
| placebo (6 weeks) fostamatinib 100 mg twice daily (4 weeks) then 150 mg once daily (25) | ||||||
| NCT00831922 4 | Phase 2a | 12 weeks | 40 (9/31) | 54.7 ± 10.8 | Multicenter, no detailed information | Fostamatinib 3 mg/kg per day (22) |
| Fostamatinib 6 mg/kg per day (18) | ||||||
| NCT00326339 13 | Phase 2 | 12 weeks | 189 (164/25) | 52.1 (20–75) median | North America (38) | Fostamatinib 50 mg twice daily (46) |
| Fostamatinib 100 mg twice daily (49) | ||||||
| Fostamatinib 150 mg twice daily (47) | ||||||
| placebo (47) | ||||||
| NCT00665925 2 | Phase 2 | 26 weeks | 457 (390/67) | 52.5 ± 12.8 | North America, Europe, South America (65) | Fostamatinib 150 mg once daily (152) |
| Fostamatinib 100 mg twice daily (152) | ||||||
| placebo (153) | ||||||
| NCT01242514 9 | Phase 3 | 109 weeks | 1912 (1576/336) | 53 ± 11.8 | North America, South America, Oceania, Europe, Asia, Africa (310) | Fostamatinib 100 mg twice daily (1343) |
| Fostamatinib 100 mg once daily (212) | ||||||
| Fostamatinib 150 mg once daily (357) | ||||||
| NCT01569074 10 | Phase 2 | 12 weeks | 163 (142/21) | 53 ± 11.9 | Asia (35) | Fostamatinib 100 mg twice daily (31) |
| Fostamatinib 75 mg twice daily (33) | ||||||
| Fostamatinib 50 mg twice daily (33) | ||||||
| Fostamatinib 100 mg twice daily (4 weeks) followed by150 mg once daily (33) | ||||||
| placebo twice daily (33) | ||||||
| NCT02092961 11 | Phase 2 | 24 weeks | 90 (65/25) | 51 ± 12.9 | North America, europe, Africa (21) | Fostamatinib 100 mg twice daily (33) |
| Adalimumab 40 mg SC (28) | ||||||
| placebo (6 weeks) then fostamatinib 100 mg twice daily (29) |