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

Pfizer

Status: Terminated

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etaneracept Smartclic

Study type: Observational

Funder types: Industry

Identifiers

NCT05891600

B1801421

NCT05891600 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
• Patients aged ≥18 years with an established diagnosis of rheumatoid arthritis according to EULAR-ACR criteria recorded in medical record.
• Patients who are on etanercept treatment and are being switched to Smartclic, or new etanercept patients that have been prescribed Smartclic® device (either in combination with a conventional synthetic DMARD or in monotherapy).
• Medical records and pharmacy claims database of the IPS available after the index date for a period of 40 weeks.

Exclusion criteria

- Any serious ongoing infections, pregnancy, or other social or medical conditions that are anticipated in the investigator's judgment to lead to discontinuation of etanercept administration with the device during the 40 weeks of data collection.

Trial design

60 participants in 1 patient group

Rheumatoid arthritis patients in Colombia

Treatment:

Drug: Etaneracept Smartclic