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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Ankylosing Spondylitis

Treatments

Biological: Golimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01668004

8259-012

2012-002458-21 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

This is an open-label, history-controlled, multi-site study of GLM in participants with AS. For evaluation of the primary study outcome measure, participants will serve as their own control. The period before start of treatment with an anti-tumor necrosis factor (TNF) agent will serve as historical control for the incidence of extra-articular manifestations, with a review of the medical records done for the previous 1-year period.

Each participant will participate in the study for approximately 12 months from the time the participant signs the Informed Consent Form through the final contact. After screening, two to four weeks before study start, each participant will be receiving study treatment for approximately 12 months, depending on the response to GLM after 3 months. All participants will be followed for a minimum of 12 months, irrespective of the duration of GLM treatment.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

May not have been treated with GLM prior to study enrollment
Must be able to provide retrospective data concerning extra-articular manifestations and episodes with a recall period of at least 12 months prior to anti-TNF use
Must have definite AS according to the modified New York criteria in the Netherlands
Must be candidate for treatment with anti-TNF agent according to the Assessment of SpondyloArthritis International Society (ASAS) consensus
Must be able to adhere to dose and visit schedules

Exclusion criteria

Any exclusion criteria stated in the Summary of Product Characteristics for golimumab
Use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening