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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Enrolling

Conditions: Arthritis, Rheumatoid

Study type: Observational

Funder types: Other

Identifiers

NCT05062421

FIS-FME-2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

540 participants in 7 patient groups

Cases 1

Description:

Patients treated with JAK-type kinase inhibitors.

Cases 2

Description:

Patients treated with monoclonal antibodies against TNF.

Cases 3

Description:

Patients treated with soluble receptor against TNF.

Cases 4

Description:

Patients treated with FAME group biosimilars.

Cases 5

Description:

Patients treated with rituximab.

Cases 6

Description:

Patients treated with abatacept.

Cases 7

Description:

Patients treated with drugs that block the IL6.