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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla540 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

540

Conditions

Arthritis, Rheumatoid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Virgen macarena

Seville, Spain

RECRUITING

Outcomes

Primary Outcomes

Survival study

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.

Time frame: Up to 60 weeks

Secondary Outcomes

Study of clinical characteristics.

To know the sociodemographic and clinical characteristics of the patients who receive FAMEsd and FAMEb in routine clinical practice at the HUVM.

Time frame: Up to 60 weeks

Measure of the influence of comorbidities.

To assess the influence of comorbidities on drug persistence.

Time frame: Up to 60 weeks

Number of participants who discontinued treatment due to serious adverse effects.

Failure due to serious adverse events, adverse events of special interest, emerging adverse events and minor adverse events that require discontinuation of the drug.

Time frame: Up to 60 weeks

Central Contacts

Blanca Estela Hernández Cruz

CONTACT

955008000 blancahcruz@gmail.com

Carlos García Pérez

CONTACT

955 04 31 27 administracion.eecc.hvm.sspa@juntadeandalucia.es

Data from ClinicalTrials.gov

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