Phase 4
N=101
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01668004 ↗Enrolled (actual)
101
Serious AEs
6.9%
Results posted
Aug 2016
Primary outcome: Primary: Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment — 0.08; 0.08 Ratio — p=1.0000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Golimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment |
0.08; 0.08 | 1.0000 |
| PRIMARY Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment |
9.8; 2.2 | <0.0001 sig |
| SECONDARY 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 |
— | — |
| SECONDARY Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM |
33.0 | — |
| SECONDARY Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM |
40.5; 19.0 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01668004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.