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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03253796
Phase
PHASE4
Status
Completed

Conditions

  • Spondyloarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — BIOLOGICAL
    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.
  • Placebo — BIOLOGICAL
    Injections of matching placebo for golimumab.

Study Details

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.

Key Dates

Start date
Nov 7, 2017
Status verified
Jul 2023
Primary completion
Mar 17, 2021
Completion
Mar 17, 2021

Study Design

Enrollment
323 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GLM SC QM (Full Treatment Regimen)
    Period 1: participants are treated with open-label (OL) GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded SC GLM QM for up to 12 months
  • Experimental: GLM SC Q2M (Reduced Treatment Regimen)
    Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded GLM SC every other month alternating with matching placebo to GLM every other month for up to 12 months
  • Placebo Comparator: Placebo (Treatment Withdrawal Regimen)
    Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded placebo for up to 12 months
  • Experimental: OL GLM Retreatment
    Participants who experience a disease flare during double-blinded treatment in Period 2 will discontinue blinded treatment and receive OL GLM SC QM.

Primary Outcome Measure

Percentage of Participants Without a Disease Activity Flare During Period 2 [ Time Frame: Up to 12 months ]

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