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

Arthritis, Rheumatoid Clinical Trial

— Arthritis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062421
• Other study ID #: FIS-FME-2020-01
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Blanca Estela Hernández Cruz
• Phone: 955008000
• Email: blancahcruz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 31, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 60 weeks
Secondary	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.	Up to 60 weeks
Secondary	Measure of the influence of comorbidities.	To assess the influence of comorbidities on drug persistence.	Up to 60 weeks
Secondary	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.	Up to 60 weeks