Study name | Study design | Malignancy screening and exclusions | Duration of double-blind period (months) | Abatacept | Placebo | Open-label extension |
Study title | ||||||
IM101100 Phase IIB | Randomised, dose-ranging, placebo-controlled, double-blind | Mammography requiring further investigation. Complete evaluation before dosing; history of cancer within the past 5 years; excluding NMSC cured by local resection | 12 | 220 | 119 | 219 |
IM101101 Phase IIB | Randomised, placebo-controlled, double blind | Mammography requiring further investigation. Complete evaluation before dosing; history of cancer within the past 5 years; excluding NMSC cured by local resection | 12 | 85 | 36 | 80 |
AIM IM101102 Phase III | Randomised, placebo controlled, double-blind; Abatacept in inadequate responders to methotrexate | Subjects with a mammogram that is suspicious for malignancy; history of cancer within the past 5 years; excluding NMSC cured by local resection | 12 | 433 | 219 | 539 |
ASSURE IM101031 Phase III | Randomised, placebo-controlled, double-blind; Abatacept Study of Safety in Use with other RA thErapies | Subjects with a mammogram that is suspicious for malignancy; history of cancer within the past 5 years; excluding NMSC cured by local resection | 12 | 959 | 482 | 1184 |
ATTAIN IM101029 Phase III | Randomised, placebo-controlled, double-blind; Abatacept Trial in Treatment of Anti-TNF INadequate responders | Subjects with a mammogram that is suspicious for malignancy; history of cancer within the past 5 years; excluding NMSC cured by local resection | 6 | 258 | 133 | 317 |
Total double-blind 5 core above | 1955 | 989 | 2689† | |||
ATTEST IM101043 | Abatacept or infliximab versus placebo, a Trial for Tolerability, Efficacy and Safety in Treating RA | History of cancer within the past 5 years; excluding NMSC cured by local resection | 12 | 156 | 110 | 236* (132 abatacept, 104 placebo, 136 infliximab) |
ARRIVE IM101064 | Abatacept Researched in Rheumatoid arthritis patients with an Inadequate anti-TNF response to Validate Effectiveness | History of cancer within the past 5 years; excluding NMSC cured by local resection | 6 (open-label) | 1046 | 530 |
*IM101043, without infliximab arm; †Number represents total number of abatacept exposed patients exposed during both double-blind and open-label; five core trials N = 2689; overall N = 4134.
NMSC, non-melanoma skin cancer; RA, rheumatoid arthritis; TNF, tumour necrosis factor.