Table 1.

Intravenous abatacept rheumatoid arthritis (RA) safety database. Data available up to November 2009.

Study	Patient Population	Interventions and Concomitant Medications During Short-term Periods^*	Numbers
Study	Patient Population		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.