NCT01692457

A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Janssen Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	No intervention	This is an observational study. Golimumab will be administered as per the recommended doses. Golimumab 50 mg will be given as a subcutaneous injection once a month, on the same date each month. For rheumatoid arthritis: Golimumab 2 mg/kg will be given as a 30 minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2012-09-25
• Last updated: 2015-12-02