Rheumatoid Arthritis Clinical Trial
Official title:
A Post-Marketing Surveillance Study on the Safety and Effectiveness of Golimumab (Simponi) Among Adult Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
The purpose of this study is to assess the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.
This is an open-label (all people know the identity of the intervention), multi-center
(study conducted at multiple sites), observational study (study in which the investigators/
physicians observe the patients and measure their outcomes) to evaluate the safety and
effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis
and ankylosing spondylitis among Filipino patients.
The study will enroll approximately 50 patients who would use golimumab with a dosing
regimen stipulated in the product insert. As this is an observational study, assessment of
patients will be based on the accepted clinical practice in the Philippines. Patients will
be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety
evaluations for adverse events, clinical laboratory tests, physical examination, concomitant
medications, and co-morbid conditions will be monitored throughout the study. The total
study will be conducted for 3 years and duration of treatment will be for 24 weeks.
;
Observational Model: Case-Only, Time Perspective: Prospective
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