Postmarketingstudy to monitor safety of golimumab injection 50milligram (mg) in Indian subjects with Rheumatoid Arthritis (RA)
Phase 4
Completed
- Conditions
- Health Condition 1: null- Indian participants with Rheumatoid Arthritis will be enrolled in the study
- Registration Number
- CTRI/2016/04/006867
- Lead Sponsor
- Johnson Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Participants of rheumatoid arthritis (RA), who are being prescribed and initiated on golimumab as per independent clinical judgment of treating Physicians based on the locally approved
Prescribing Information Participants
must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and willing to participate in the study
Exclusion Criteria
Participants participating or planning to participate in any interventional drug trial during the course of this study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and drug related AEs <br/ ><br> <br/ ><br>Percentage of participants with Infections and Serious InfectionsTimepoint: Up to 8 months
- Secondary Outcome Measures
Name Time Method Following parameters associated with usage of Simponi�® (golimumab, 50 mg SC injection) <br/ ><br>1. Baseline subject and disease characteristics <br/ ><br>2. Progression of disease <br/ ><br>3. Change in subject reported outcomes HAQ-DI, FACIT-F, Satisfaction and user-friendliness of autoinjector, Pain and other reactions at injection site, Actual timing of golimumab dose interval, methotrexate dose (mg per week) and folic acid (mg per week)Timepoint: Up to 8 months