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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Estimated): 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Colombia
  • Bogotá, Colombia
    • Biomab IPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study data will be collected from medical records containing the Smartclic device injection log and pharmacy claims database available from a rheumatologist institution. The study will only include clinical records of patients who received treatment with etanercept and meet the selection criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid arthritis patients in Colombia	Device: Smartclic; The SmartClic® autoinjector is a reusable, electromechanical, and single-patient device for the administration of subcutaneously administered biologics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence (Pharmacy claims source)	The percentage of patients with Percentage of days covered (PDC) ≥ 80%	Baseline through week 40
Change From Baseline in Disease Activity Score Based on 28-joints Count with ESR (DAS28-ESR) at 40 week		Baseline, Week 40
Change From Baseline in Functional status Based on Multidimensional Health Assessment Questionnaire (MDHAQ) at 40 week		Baseline, Weeks 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adherence from Smartclic® injection log	Percentage of patients with administration ≥ 80% based on the injection log of the e-Device	Week 40

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): October 22, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Observational study
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: B1801421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.