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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 101
- Primary Endpoint
- Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Annual Incidence Rate of New 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
Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no "new attack" after GLM treatment start.
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
Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.
Secondary Outcomes
- Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM(Baseline (BL), Study Month 3)
- Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM(BL, Study Month 3)
- Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment(Twelve Months Prior to Enrollment to Study Month 12)