Table 1

Golimumab clinical trials contributing data to 3-year pooled safety analyses

Trial phase/identifierIndicationStudy designStudy treatmentPatients randomised/treated
Phase IIb8 (for rare events only)RA, inadequate response to MTXMulticentre, randomised (1:1:1:1:1), double-blind, placebo-controlled, 5-arm, dose-ranging studyFixed SC doses of placebo or golimumab
▸ Placebo+MTX: wk 0 and q2w to wk 18 with crossover to IV infliximab (3 mg/kg) at wks 20, 22, and 28, and then q8w to wk 44
▸ Golimumab 50 mg+MTX: wk0 and q4w to wk 0 and wk 48
▸ Golimumab 50 mg+MTX: wk 0 and q2w to wk 18, then q4w wks 20–48
▸ Golimumab 100 mg+MTX: wk 0 and q4w to wk 48
▸ Golimumab 100 mg+MTX: wk 0 and q2w to wk 18, then q4w for wks 20–48
Placebo: 35/34
Golimumab: 137/137
Total: 172/171
Phase III, GO-BEFORE9 10RA, MTX-naïveMulticenter, randomised (1:1:1:1), double-blind, placebo-controlled to wk 52 with early escape* at wk 28, followed by open-label golimumab from wk 52 DBL forwardFixed SC doses of placebo or golimumab
▸ Placebo+MTX q4w
▸ Golimumab 100 mg q4w+placebo
▸ Golimumab 50 mg q4w+MTX
▸ Golimumab 100 mg q4w+MTX; All to wk 52 with early escape at wk 28*
Beginning at wk 52, placebo+MTX-treated pts crossed over to golimumab 50 mg+MTX,
During the OLE, the investigator could escalate open-label golimumab to 100 mg and/or adjust the MTX dose
Placebo: 160/160
Golimumab: 477/474
Total: 637/633
Phase III, GO-FORWARD11–13RA, inadequate response to MTXMulticentre, randomised (3:3:2:2), double-blind, placebo-controlled to wk 24 with early escape* at wk 16, followed by blinded golimumab to wk 52 and then open-label golimumab from wk 52 DBL forwardFixed SC doses of placebo or golimumab
▸ Placebo+MTX q4w
▸ Golimumab 100 mg q4w+placebo
▸ Golimumab 50 mg q4w+MTX
▸ Golimumab 100 mg q4w+MTX; All to wk 24 with early escape at wk 16*
Beginning at wk 24, placebo+MTX-treated pts crossed over to double-blind golimumab 50mg+MTX
During the OLE, the investigator could escalate open-label golimumab to 100 mg and/or adjust the MTX dose
Placebo: 133/133
Golimumab: 311/311
Total: 444/444
Phase III, GO-AFTER14 15RA, inadequate response to anti-TNFMulticentre, randomised (1:1:1), double-blind, placebo-controlled to wk 24 with early escape* at wk 16, followed by open-label golimumab after wk 24 DBLFixed SC doses of placebo or golimumab
▸ Placebo q4w
▸ Golimumab 50 mg 4w
▸ Golimumab 100 mg q4w; All to wk 24 with early escape at wk 16*
Beginning at wk 24, placebo-treated pts crossed over to golimumab 50 mg
During the OLE, the investigator could escalate open-label golimumab to 100 mg
Placebo: 155/155
Golimumab: 306/306
Total: 461/461
Phase III, GO-REVEAL16–18PsA, inadequate response to DMARDs/NSAIDsMulticentre, randomised (1:1.3:1.3), double-blind, placebo-controlled to wk 24 with early escape* at wk 16, followed by blinded golimumab from wk 24 forward. Blinded therapy continued to wk 52 DBL, after which the long-term OLE beganFixed SC doses of placebo or golimumab
▸ Placebo
▸ Golimumab 50 mg q4w
▸ Golimumab 100 mg q4w; All to wk 24 with early escape at wk 16*
Beginning at wk 24, placebo-treated pts crossed over to golimumab 50 mg
During the OLE, the investigator could escalate the golimumab dose to 100 mg
Placebo: 113/113
Golimumab: 292/292
Total: 405/405
Phase III, GO-RAISE19 20AS, inadequate response to DMARDs/NSAIDsMulticentre, randomised (1:1.8:1.8), double-blind, placebo-controlled to wk 24 with early escape* at wk 16, followed by dose-blinded golimumab from wk 24 forward. Blinded therapy continued to wk 104 DBL, after which the long-term OLE beganFixed SC doses of placebo or golimumab
▸ Placebo
▸ Golimumab 50 mg q4w
▸ Golimumab 100 mg q4w; All to wk 24 with early escape at wk 16*
Beginning at wk 24, placebo-treated pts crossed over to golimumab 50 mg
During the OLE, the investigator could escalate the golimumab dose to 100 mg
Placebo: 78/78
Golimumab: 278/277
Total: 356/355
  • *For patients meeting the early escape criteria (ie, <20% improvement in tender and swollen joint counts for RA, <10% improvement in tender and swollen joint counts for PsA, <20% improvement in total back and morning stiffness for AS), those receiving placebo escaped to golimumab 50 mg, those receiving golimumab 100 mg+placebo added MTX, those receiving golimumab 50 mg increased the golimumab dose to 100 mg, and those receiving golimumab 100 mg had no change in study medication.

  • AS, ankylosing spondylitis; DBL, database lock; DMARD, disease-modifying antirheumatic drug; IV, intravenous; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; OLE, open-label extension; PsA, psoriatic arthritis; pt, patient; RA, rheumatoid arthritis; SC, subcutaneous; TNF, tumour necrosis factor; q2/4/8w, every 2/4/8 weeks; wk, week.