Registry for safety of systemic treatments in psoriasis
Spanish Registry of Systemic Treatments in Psoriasis
This study looks at the safety of different treatments for psoriasis, comparing those using biologic medications to those on traditional drugs, to see how they affect patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Sex | All |
| Sponsor | Fundación Academia Española de Dermatología Academic / other |
| Drugs / interventions | infliximab, efalizumab, adalimumab, rituximab, ustekinumab, methotrexate |
| Locations | 13 sites (Badalona, Barcelona and 12 other locations) |
| Trial ID | NCT02075697 on ClinicalTrials.gov |
What this trial studies
The Spanish Registry for Adverse Events of Biological Therapies in Dermatology (BIOBADADERM) aims to study the safety of systemic therapies in psoriasis patients. This observational cohort study compares patients receiving biologic treatments, such as infliximab and etanercept, with those starting nonbiologic systemic treatments like methotrexate. The registry, managed by the Foundation of the Spanish Academy of Dermatology and Venereology, collects data on adverse events to identify their frequency and any unexpected occurrences over time. It is part of a European network for sharing patient data treated with biologics.
Who should consider this trial
Good fit: Ideal candidates include psoriasis patients who are beginning treatment with either biologic or nonbiologic systemic therapies.
Not a fit: Patients who are not starting a new systemic treatment or those planning to relocate in the near future may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety profiles of various systemic treatments for psoriasis, leading to better patient care.
How similar studies have performed: Other studies have successfully utilized similar registry approaches to monitor the safety of biologic therapies in various conditions, indicating a promising methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For biologics group: all consecutive psoriasis patients who begin any biological therapy * For classic systemic group: the next psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (after including a patient in the biologics group) Exclusion Criteria: * Intention of moving to a different geographic area in the next three months
Where this trial is running
Badalona, Barcelona and 12 other locations
- Hospital Universitari German Trias y Pujol. — Badalona, Barcelona, Spain (Recruiting)
- Fundación Hospital Alcorcón — Alcorcón, Madrid, Spain (Recruiting)
- Hospital General Universitario de Alicante — Alicante, Spain (Recruiting)
- Hospital Clinic — Barcelona, Spain (Recruiting)
- Hospital del Mar. IMAS — Barcelona, Spain (Recruiting)
- Hospital Universitario Reina Sofía — Córdoba, Spain (Recruiting)
- Hospital Universitario de Gran Canaria Dr Negrín — Las Palmas, Spain (Recruiting)
- Hospital Infanta Leonor — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario de la Princesa — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Victoria — Málaga, Spain (Recruiting)
- Hospital Universitario Virgen Macarena de Sevilla — Sevilla, Spain (Recruiting)
- Hospital General Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Esteban Daudén, PhD — Hospital de La Princesa- Madrid
- Study coordinator: Ignacio Garcia-Doval, PhD, MScEpid
- Email: investigacion@aedv.es
- Phone: 34- 915446284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.