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

NCT ID: NCT01668004

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-03
• Study Completion Date: 2015-04-30

Brief 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).

Detailed 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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLM 50 mg

GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: BIOLOGICAL

GLM 50 mg subcutaneously once monthly.

Interventions

Golimumab

GLM 50 mg subcutaneously once monthly.

Intervention Type: BIOLOGICAL

Other Intervention Names

Simponi®

Eligibility Criteria

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

• Use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 30385705 (View on PubMed)

Other Identifiers

2012-002458-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8259-012

Identifier Type: -

Identifier Source: org_study_id