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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure of the influence of comorbidities. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blanca Estela Hernández Cruz | Contact | 955008000 | blancahcruz@gmail.com | |
| Carlos García Pérez | Contact | 955 04 31 27 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Blanca Estela Hernández Cruz | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen macarena | Recruiting | Seville | 41009 | Spain |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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To assess the influence of comorbidities on drug persistence.
| Up to 60 weeks |
| 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |