CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 323 enrolled
Drug / intervention
Golimumab +1 morebiological
Likely dose
Golimumab 50 mg injections; 100 mg for patients >100 kg body weightAI-extracted
Key inclusion· 8
  • ✓Chronic back pain ≥3 months duration
  • ✓Physician-diagnosed active non-radiographic axial spondyloarthritis with disease duration ≤5 years
  • ✓Either MRI-confirmed active inflammation in sacroiliac joints suggestive of sacroiliitis with ≥1 SpA characteristic OR HLA-B27+ with ≥2 SpA characteristics
  • ✓Elevated CRP at screening or MRI evidence of active sacroiliac inflammation
Key exclusion· 12
  • ✕Bilateral sacroiliitis Grade 2 or unilateral Grade 3-4 on x-rays
  • ✕Prior cytotoxic drug exposure (chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents)
  • ✕Active systemic inflammatory conditions including psoriatic arthritis, active Lyme disease, SLE, infectious arthritis, vasculitis, rheumatoid arthritis, active uveitis, or active IBD
  • ✕History of latent or active granulomatous infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03253796
NCT03253796Phase 4Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Aug 18, 2017·Updated Jul 28, 2023

In Brief

A Phase 4 clinical trial evaluating Golimumab and Placebo for Spondyloarthritis. Completed, enrolled 323 participants across 71 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpondyloarthritis
CountriesCzechia, Germany, Netherlands, Poland, Romania, Russia, Spain, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 18, 2017
Enrollment StartNov 7, 2017
Primary CompletionMar 17, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.9 years ago

Interventions

Golimumabbiological

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.

Placebobiological

Injections of matching placebo for golimumab.