Study | Patient Population | Interventions and Concomitant Medications During Short-term Periods* | Numbers | |
---|---|---|---|---|
Short-term Period† | Cumulative Period†# | |||
Phase IIb RCT dose-finding (NCT00162266)1 | MTX inadequate responders | Abatacept 10 mg/kg vs abatacept 2 mg/kg vs placebo, plus background MTX | 220 | 287 |
Phase IIb RCT abatacept plus etanercept (NCT00162279)14 | Etanercept inadequate responders | Abatacept 2 mg/kg/mo vs placebo, plus etanercept 25 mg (twice weekly) | 85 | 107 |
Phase III RCT AIM (NCT00048568)2 | MTX inadequate responders | Abatacept 10 mg/kg vs placebo, plus background MTX | 433 | 594 |
Phase III RCT ATTAIN (NCT00048581)4 | Anti-TNF inadequate responders | Abatacept 10 mg/kg vs placebo, plus background nonbiologic DMARD | 258 | 357 |
Phase III RCT ASSURE (NCT00048932)5 | DMARD or biologic inadequate responders | Abatacept 10 mg/kg vs placebo, plus background DMARD and/or biologic therapy | 959 | 1343 |
Phase III RCT ATTEST (NCT00095147)15 | MTX inadequate responders | Abatacept 10 mg/kg vs infliximab 3 mg/kg vs placebo, plus background MTX | 156 | 399 |
Phase II open-label MoA (NCT00162201)16 | Anti-TNF inadequate responders | Open-label abatacept 10 mg/kg, plus background nonbiologic DMARD | 16 | 16 |
Phase III open-label ARRIVE (NCT00162201)17 | Anti-TNF inadequate responders | Open-label abatacept 10 mg/kg, plus background nonbiologic DMARD | 1046 | 1046 |
Total | 3173 | 4149 |
↵* Patients switched to open-label intravenous (IV) abatacept (∼10 mg/kg according to weight range) if they entered the open-label longterm extensions, during which changes to concomitant and background medications were permitted.
↵† Patients receiving IV abatacept.
↵# Some patients from other treatment groups crossed over to IV abatacept treatment duing open-label extensions. RCT: randomized controlled trial; MTX: methotrexate; AIM: Abatacept in Inadequate responders to Methotrexate; ATTAIN: Abatacept Trial in Treatment of Anti-TNF INadequate responders; TNF: tumor necrosis factor; DMARD: disease-modifying antirheumatic drug; ASSURE: Abatacept Study of Safety in Use with other RA therapies; ATTEST: Abatacept or infliximab versus placebo, a Trial for Tolerability, Efficacy and Safety in Treating RA; MoA: mechanism of action; ARRIVE: Abatacept Researched in RA patients with an Inadequate anti-TNF response to Validate Effectiveness.