NCT03253796

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

A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Golimumab	Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.
BIOLOGICAL	Placebo	Injections of matching placebo for golimumab.

Timeline

• Start date: 2017-11-07
• Primary completion: 2021-03-17
• Completion: 2021-03-17
• First posted: 2017-08-18
• Last updated: 2023-07-28
• Results posted: 2022-05-04

Locations

71 sites across 9 countries: Czechia, Germany, Netherlands, Poland, Romania, Russia, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study