The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) (GO-EASY)
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 treatment and after the start of treatment with golimumab.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Phase 4 Study, Investigating the Incidence of Extra-Articular Manifestations in Subjects With Ankylosing Spondylitis Treated With Golimumab; Protocol No. MK-8259-012|
- Annual Incidence Rate of Uveitis Attacks in Participants Before Treatment and After the Start of Treatment with Golimumab [ Time Frame: Twelve Months Prior to Enrollment to Study Month 12 ] [ Designated as safety issue: No ]
- Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Treatment and After the Start of Treatment With Golimumab [ Time Frame: Twelve Months Prior to Enrollment to Study Month 12 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Following Treatment With Golimumab [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in the Ankylosing Spondylitis Disease Activity Score (ASDAS) Following Treatment With Golimumab [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Golimumab 50 mg
Golimumab dosed subcutaneously at a dose of 50 mg once monthly for up to 12 months.
Golimumab 50 mg subcutaneously once monthly.
Other Name: Simponi®
This is an open-label, history-controlled, multi-site study of golimumab 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. Two to four weeks before study start, each participant will be receiving study treatment for approximately 12 months, depending on the response to golimumab after 3 months. All participants will be followed for a minimum of 12 months, irrespective of the duration of golimumab treatment.
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