Pivotal phase 3 GOL trials contributing data to 5-year pooled safety analyses.
| Indication/Trial Identifier | Patients | Study Design | Study Treatment |
|---|---|---|---|
| RA | |||
| GO-BEFORE8,9,10 | RA, MTX-naive | Multicenter, randomized (1:1:1:1), double-blind, placebo-controlled through Week 52 with early escape1 at Week 28, followed by OL GOL after Week 52 DBL. | Fixed SC doses q4wk through Week 52 with early escape1 at Week 28: placebo + oral MTX, GOL 100 mg + oral placebo, GOL 50 mg + oral MTX, GOL 100 mg + oral MTX. Starting at Week 52, placebo patients crossed over to GOL 50 mg q4wk. During the OLE, the investigator could increase/decrease the OL GOL dose to 100/50 mg q4wk, respectively, and/or adjust the MTX dose. |
| GO-FORWARD11,12,13,14 | RA, inadequate response to MTX | Multicenter, randomized (3:3:2:2), double-blind, placebo-controlled through Week 24 with early escape1 at Week 16, followed by blinded GOL through Week 52 and OL GOL after Week 52 DBL. | Fixed SC doses q4wk through Week 24 with early escape1 at Week 16: placebo + oral MTX, GOL 100 mg + oral placebo, GOL 50 mg + oral MTX, GOL 100 mg + oral MTX. Starting at Week 24, placebo patients crossed over to double-blind GOL 50 mg q4wk. During the OLE, the investigator could increase/decrease the OL GOL dose to 100/50 mg q4wk, respectively, and/or adjust the MTX dose. |
| GO-AFTER15,16,17 | RA, inadequate response to prior TNF antagonist(s) | Multicenter, randomized (1:1:1), double-blind, placebo-controlled through Week 24 with early escape1 at Week 16, followed by OL GOL after Week 24 DBL (MTX allowed, but not required). | Fixed SC doses q4wk through Week 24 with early escape1 at Week 16: placebo, GOL 50 mg, GOL 100 mg. Starting at Week 24, placebo patients crossed over to OL GOL 50 mg q4wk. During the OLE, the investigator could increase/decrease the OL GOL dose to 100/50 mg q4wk, respectively. |
| PsA | |||
| GO-REVEAL18,19,20,21 | PsA, inadequate response to DMARD/NSAID | Multicenter, randomized (1:1.3:1.3), double-blind, placebo-controlled through Week 24 with early escape1 at Week 16, followed by blinded GOL from Week 24 through Week 52 DBL and then OL GOL (MTX allowed, but not required). | Fixed SC doses q4wk through Week 24 with early escape1 at Week 16: placebo, GOL 50 mg, GOL 100 mg. Beginning at Week 24, placebo patients crossed over to GOL 50 mg q4wk. During the OLE, the investigator could increase/decrease the OL GOL dose to 100/50 mg q4wk, respectively. |
| AS | |||
| GO-RAISE22,23,24 | AS, inadequate response to DMARD/NSAID | Multicenter, randomized (1:1.8:1.8), double-blind, placebo-controlled through Week 24 with early escape1 at Week 16, followed by dose-blinded GOL from Week 24 forward. Blinded therapy continued through Week 104 DBL followed by OL GOL. | Fixed SC doses q4wk through Week 24 with early escape1 at Week 16: placebo, GOL 50 mg, GOL 100 mg. Starting at Week 24, placebo patients crossed over to GOL 50 mg q4wk. During the OLE, the investigator could increase/decrease the OL GOL dose to 100/50 mg q4wk, respectively. |
↵1 For patients meeting the early escape criteria (i.e., < 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 GOL 50 mg, those receiving GOL 100 mg + placebo added MTX, those receiving GOL 50 mg increased the GOL dose to 100 mg, and those receiving GOL 100 mg had no change in study medication. GOL: golimumab; RA: rheumatoid arthritis; MTX: methotrexate; TNF: tumor necrosis factor; PsA: psoriatic arthritis; DMARD: disease-modifying antirheumatic drug; NSAID: nonsteroidal antiinflammatory drug; AS: ankylosing spondylitis, OL: open label; DBL: database lock; q4wk: every 4 weeks; OLE: open-label extension; SC: subcutaneous.