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

November 15, 2021 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Recruiting

Conditions

Arthritis, Rheumatoid

Detailed Description

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 (Anticipated)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Carlos García Pérez
Phone Number: 955 04 31 27
Email: administración.eecc.hvm.sspa@juntadeandalucia.es

Study Contact Backup

Name: Blanca Estela Hernández Cruz
Phone Number: 955008000
Email: blancahcruz@gmail.com

Study Locations

Spain
- - Sevilla, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
    - Contact:
      
      Blanca Estela Hernández Cruz
      
      Phone Number: 955008000
      
      Email: blancahcruz@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged > 18 years diagnosed with rheumatoid arthritis, who have been under treatment with at least one dose of the study drugs, whose treatment is followed by the rheumatology unit.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cases 1 Patients treated with JAK-type kinase inhibitors.
Cases 2 Patients treated with monoclonal antibodies against TNF.
Cases 3 Patients treated with soluble receptor against TNF.
Cases 4 Patients treated with FAME group biosimilars.
Cases 5 Patients treated with rituximab.
Cases 6 Patients treated with abatacept.
Cases 7 Patients treated with drugs that block the IL6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival study Time Frame: 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.	Up to 60 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of clinical characteristics. Time Frame: 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.	Up to 60 weeks
Measure of the influence of comorbidities. Time Frame: Up to 60 weeks	To assess the influence of comorbidities on drug persistence.	Up to 60 weeks
Number of participants who discontinued treatment due to serious adverse effects. Time Frame: 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.	Up to 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

Principal Investigator: Blanca Estela Hernández Cruz, Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified