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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01692457
Study type Observational
Source Janssen Pharmaceutica
Contact
Status Withdrawn
Phase Phase 4
Start date July 2013
Completion date July 2016

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