Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT05891600 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
The study was terminated following a comprehensive review of the collected data and an assessment of the study's completeness. This decision was made to maintain scientific standards and ethical conduct, and to prevent potentially inaccurate results
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis patients in Colombia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etaneracept Smartclic | Drug | The SmartClic® autoinjector is a reusable, electromechanical, and single-patient device for the administration of subcutaneously administered biologics. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomab Ips S.A.S. | Bogotá | 110231 | Colombia |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Percentage of patients with administration ≥ 80% based on the injection log of the e-Device
| Week 40 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |