The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)

Phase 4 Completed 101 enrolled Merck Sharp & Dohme LLC

NaSingle-groupOpen-labelTreatment

Summary

The objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (AS) before start initial anti-TNF therapy and after treatment with golimumab (GLM).

Timeline

Start: 2012-09-03
Primary completion: 2015-04-30
Completion: 2015-04-30

Outcome

Mixed primary results

registry Before Initial Anti-TNF/GLM Treatment vs After GLM Treatment Start; p = 1.0000; McNemar NCT01668004 ↗

registry NUMBER Before Initial Anti-TNF/GLM Treatment: 9.8 Events per 100 participant years NUMBER After GLM Treatment Start: 2.2 Events per 100 participant years analysis (superiority or other test); Before Initial Anti-TNF/GLM Treatment vs After GLM Treatment Start; p <0.0001 NCT01668004 ↗

Publications

Background van Bentum RE, Heslinga SC, Nurmohamed MT, Gerards AH, Griep EN, Koehorst CBJM, Kok MR, Schilder AM, Verhoef M, van der Horst-Bruinsma IE. Reduced Occurrence Rate of Acute Anterior Uveitis in Ankylosing Spondylitis Treated with Golimumab - The GO-EASY Study. J Rheumatol. 2019 Feb;46(2):153-159. doi: 10.3899/jrheum.180312. Epub 2018 Nov 1.

Drugs

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