NCT05891600

A Study to Learn About the Adherence and Clinical Outcomes in Colombian Patients With an E-Device for Etanercept Administration in Rheumatoid Arthritis

Adherence and Clinical Outcomes in Patients With e-Device for Etanercept Administration in Rheumatoid Arthritis Patients: Real Word Evidence in a Colombian Institution.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a descriptive, ambispective, and single-site study in Colombia, which is designed to evaluate the adherence, persistence, and clinical outcomes (defined as the patient's disease activity and functional status) of RA patients within 40 weeks after the patient administered the first injection of the etanercept medication through the Smartclic® device. The study data seeks from medical records containing the Smartclic device injection log and pharmacy claims database available from an institution specialized in rheumatological care. The study will only include records of patients treated or starting treatment with etanercept and whose indicated autoinjection device has been Smartclic.

Detailed description

Non-interventional study: The clinical records of eligible patients will be identified by the rheumatologist from the patients who attended the rheumatologist visit or institutional training sessions according to the standard of care. Patients have been prescribed etanercept according to the standard of care, and Smartclic has been indicated as an administration method.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etaneracept Smartclic	The SmartClic® autoinjector is a reusable, electromechanical, and single-patient device for the administration of subcutaneously administered biologics.

Timeline

• Start date: 2024-06-06
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-06-07
• Last updated: 2025-11-20

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated drug study