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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01668004
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — BIOLOGICAL
    GLM 50 mg subcutaneously once monthly.

Study Details

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).

Key Dates

Start date
Sep 3, 2012
Status verified
Jan 2019
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
101 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment [ Time Frame: Twelve Months Prior to Enrollment to Study Month 12 ]

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