Persistence of Biological Treatment and Inhibitors of Jak Kinases in Patients With Rheumatoid Arthritis.

Recruiting

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT05062421
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).

These patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.

Detailed Description

One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).

The drugs to be administered to patients are:

* JAK-type kinase inhibitors.

* Monoclonal antibodies against TNF.

* Soluble receptor against TNF.

* Biosimilar FAMEb.

* Rituximab.

* Abatacept.

* Drugs that block IL6.

A follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Patients aged ≥18 years.
• With a diagnosis of Adult Rheumatoid Arthritis according to the 2010 ACR / EULAR criteria.
• Who have received at least one of the doses of the study drugs.
• In follow-up in the consultations of the UGC of Rheumatology of the HUVM.
• With at least two complete evaluations (baseline and final) of clinical variables.

Exclusion Criteria

• Patients where the medical records lack sufficient baseline and final variables to perform the analysis.
• Patients in whom more than 50% of the variables to be collected are missing in the data collection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival study	Up to 60 weeks	To know the survival at 12, 24, 48, 60, 72 and 84 months to the synthetic directed anti-rheumatic drugs, disease modifiers (FAMEsd) and the biological disease modifying anti-rheumatic drugs (FAMEb) in patients with rheumatoid arthritis treated in routine.

Secondary Outcome Measures

Name	Time	Method
Study of clinical characteristics.	Up to 60 weeks	To know the sociodemographic and clinical characteristics of the patients who receive FAMEsd and FAMEb in routine clinical practice at the HUVM.
Measure of the influence of comorbidities.	Up to 60 weeks	To assess the influence of comorbidities on drug persistence.
Number of participants who discontinued treatment due to serious adverse effects.	Up to 60 weeks	Failure due to serious adverse events, adverse events of special interest, emerging adverse events and minor adverse events that require discontinuation of the drug.

Trial Locations

Locations (1)

Hospital Universitario Virgen macarena; 🇪🇸 Sevilla, Spain