Persistence of Biological Treatment and Inhibitors of Jak Kinases in Patients With Rheumatoid Arthritis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Arthritis, Rheumatoid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.
Overview
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.
Primary outcome measures
- Survival study [Time frame: Up to 60 weeks]
Secondary outcome measures (3)
- Study of clinical characteristics. [Time frame: Up to 60 weeks]
- Measure of the influence of comorbidities. [Time frame: Up to 60 weeks]
- Number of participants who discontinued treatment due to serious adverse effects. [Time frame: Up to 60 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 1 center
- Hospital Universitario Virgen macarena — Seville
Identifiers
NCT: NCT05062421 · FIS-FME-2020-01