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Postmarketing study to monitor safety of golimumab injection 50 milligram (mg) in Indian subjects with Rheumatoid Arthritis (RA)

A prospective, multicentre postmarketing surveillance to monitor safety associated with usage of Simponi�® (golimumab injection 50mg) in Indian subjects with Rheumatoid Arthritis as per locally approved prescribing information

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/04/006867
Enrollment
119
Registered
2016-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Indian participants with Rheumatoid Arthritis will be enrolled in the study

Interventions

Intervention1: NIL: This is an observational study and participants will not receive any intervention as a part of this study. All prospective participants who will be prescribed Simponi�® as per in

Sponsors

Johnson Johnson Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Participants participating or planning to participate in any interventional drug trial during the course of this study

Design outcomes

Primary

MeasureTime frame
Percentage of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and drug related AEs Percentage of participants with Infections and Serious InfectionsTimepoint: Up to 8 months

Secondary

MeasureTime frame
Following parameters associated with usage of Simponi�® (golimumab, 50 mg SC injection) 1. Baseline subject and disease characteristics 2. Progression of disease 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

Countries

India

Contacts

Public ContactDr Jitendra R Dixit

Johnson and Johnson Private Limited

jdixit@its.jnj.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026