A Study to Assess the Safety and Effectiveness of Golimumab in 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.
Drug: No intervention
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Number of patients with incidence of adverse events [ Time Frame: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years ] [ Designated as safety issue: Yes ]
- Number of patients with incidence of discontinuation of study medication due to adverse events [ Time Frame: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years ] [ Designated as safety issue: Yes ]
- Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]HAQ will include 2 scales: (a) scale for evaluating disability (score range, 0 [without any difficulty] to 3 [unable to do]) and (b) Visual Analogue Scale for evaluating discomfort and pain (score range, 0 [no pain] to 100 [severe pain]).
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.
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.
Other Name: SIMPONI
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692457
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|