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

Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05062421

Acronym

Arthritis

Enrollment

540

Registered

2021-09-30

Start date

2021-04-01

Completion date

2026-12-31

Last updated

2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Contacts

Primary ContactBlanca Estela Hernández Cruz

blancahcruz@gmail.com955008000

Backup ContactCarlos García Pérez

administracion.eecc.hvm.sspa@juntadeandalucia.es955 04 31 27

Outcome results