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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-06

Study Completion Date

2025-05-30

Brief Summary

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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.

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Detailed Description

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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

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Rheumatoid arthritis patients in Colombia

Etaneracept Smartclic

Intervention Type DRUG

The SmartClic® autoinjector is a reusable, electromechanical, and single-patient device for the administration of subcutaneously administered biologics.

Interventions

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Etaneracept Smartclic

The SmartClic® autoinjector is a reusable, electromechanical, and single-patient device for the administration of subcutaneously administered biologics.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No