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Table 1 Description of the abatacept clinical trials included in the current analysis

From: Infections requiring hospitalization in the abatacept clinical development program: an epidemiological assessment

Study name

Study design/study title/DB enrollment period

Duration of double-blind period (months)

abatacept

PBO

Open-label extension

IM101101 [6] Phase IIB

Randomized, placebo-controlled, double-blind/2001 to 2002

12

85

36

80

IM101100 [7, 8] Phase IIB

Randomized, dose-ranging, placebo-controlled, double-blind/2001 to 2002

12

220

119

219

ATTAIN [9]

IM101029 Phase III

Randomized, placebo-controlled, double-blind/Abatacept Trial in Treatment of Anti-TNF INadequate responders/2002 to 2003

6

258

133

317

AIM [10]

IM101102 Phase III

Randomized, placebo controlled, double-blind/Abatacept in Inadequate responders to MTX/2002 to 2003

12

433

219

539

ASSURE [11]

IM101031 Phase III

Randomized, placebo-controlled, double-blind/Abatacept Study of Safety in Use with other RA therapies/2002 to 2003

12

959

482

1184

 

Total double-blind 5 core above

 

1955

989

2689**

ATTEST [15]

IM101043

Abatacept or infliximab versus placebo, a Trial for Tolerability, Efficacy and Safety in Treating RA/2005 to 2006

12

156

110

236*

(132 aba, 104 placebo, 136 infliximab)

ARRIVE [16]

IM101064

Abatacept Researched in Rheumatoid arthritis patients with an Inadequate anti-TNF response to Validate Effectiveness/2005 to 2006

6 (open-label)

1046

 

530

  1. *IM101043, without infliximab arm; **Number represents total number of abatacept exposed patients exposed during both double-blind and open-label; five core trials N = 2,689, overall N = 4,134.