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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05891600
• Other study ID #: B1801421
• Status: Not yet recruiting
• Start date: February 15, 2024
• Est. completion date: October 22, 2024

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: October 22, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Colombia	Biomab IPS	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence (Pharmacy claims source)	The percentage of patients with Percentage of days covered (PDC) = 80%	Baseline through week 40
Primary	Change From Baseline in Disease Activity Score Based on 28-joints Count with ESR (DAS28-ESR) at 40 week		Baseline, Week 40
Primary	Change From Baseline in Functional status Based on Multidimensional Health Assessment Questionnaire (MDHAQ) at 40 week		Baseline, Weeks 40
Secondary	Persistence	Number of days to discontinuation from the index date (date that the patient administered the first injection of the etanercept medication through the Smartclic device)	Week 40
Secondary	Adherence from Smartclic® injection log	Percentage of patients with administration = 80% based on the injection log of the e-Device	Week 40