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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

540 Participants
are grouped into 7 trial groups

7

Trial groups

See each trial group below.

Group A: Cases 1
Group B: Cases 2
Group C: Cases 3
Group D: Cases 4
Group E: Cases 5
Group F: Cases 6
Group G: Cases 7

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 60 weeks

Secondary outcomes

1

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.

Time frame
Up to 60 weeks
2

Measure of the influence of comorbidities.

To assess the influence of comorbidities on drug persistence.

Time frame
Up to 60 weeks
3

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.

Time frame
Up to 60 weeks

Other outcomes

Sponsors and contacts

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