Clinical trial NCT05891600: A Study to Learn About the Adherence and Clinical Outcomes in Colombian Patients With an E-Device for Etanercept Administration in Rheumatoid Arthritis
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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: Observational study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence (Pharmacy claims source)
timeFrame: Baseline through week 40
measure: Change From Baseline in Disease Activity Score Based on 28-joints Count with ESR (DAS28-ESR) at 40 week
timeFrame: Baseline, Week 40
measure: Change From Baseline in Functional status Based on Multidimensional Health Assessment Questionnaire (MDHAQ) at 40 week
timeFrame: Baseline, Weeks 40
Secondary outcomes:
measure: Persistence
timeFrame: Week 40
measure: Adherence from Smartclic® injection log
timeFrame: Week 40
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Biomab Ips S.A.S.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: