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NCT Number: NCT05062421

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

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen macarena

Seville, 41009, Spain

Location status: Recruiting

Location contact

Blanca Estela Hernández Cruz

CONTACT

[email protected]

955008000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Measure of the influence of comorbidities.

    Time frame: Up to 60 weeks

    To assess the influence of comorbidities on drug persistence.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Blanca Estela Hernández Cruz

CONTACT

[email protected]

955008000

Carlos García Pérez

CONTACT

[email protected]

955 04 31 27

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

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

Acronym: Arthritis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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