Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)

Phase 4 Completed 323 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

Timeline

Start: 2017-11-07
Primary completion: 2021-03-17
Completion: 2021-03-17

Outcome

Met primary endpoint

registry analysis (superiority test); Golimumab QM (Full Treatment Regimen) vs Placebo (Treatment Withdrawal Regimen); p <0.001; Difference in percentage 50.2 NCT03253796 ↗

registry analysis (superiority test); Golimumab Q2M (Reduced Treatment Regimen) vs Placebo (Treatment Withdrawal Regimen); p <0.001; Difference in percentage 34.4 NCT03253796 ↗

Publications

Results Weinstein CLJ, Sliwinska-Stanczyk P, Hala T, Stanislav M, Tzontcheva A, Yao R, Berd Y, Curtis SP, Philip G. Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumatology (Oxford). 2023 Nov 2;62(11):3601-3609. doi: 10.1093/rheumatology/kead112.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Golimumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Golimumab	Monoclonal antibody	100 mg	Subcutaneous