Trial phase/identifier | Indication | Study design | Study treatment | Patients randomised/treated |
---|---|---|---|---|
Phase IIb8 (for rare events only) | RA, inadequate response to MTX | Multicentre, randomised (1:1:1:1:1), double-blind, placebo-controlled, 5-arm, dose-ranging study | Fixed 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 10 | RA, MTX-naïve | Multicenter, 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 forward | Fixed 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-FORWARD11–13 | RA, inadequate response to MTX | Multicentre, 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 forward | Fixed 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 15 | RA, inadequate response to anti-TNF | Multicentre, 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 DBL | Fixed 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-REVEAL16–18 | PsA, inadequate response to DMARDs/NSAIDs | Multicentre, 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 began | Fixed 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 20 | AS, inadequate response to DMARDs/NSAIDs | Multicentre, 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 began | Fixed 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.