Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Observational [Patient Registry]|
|Eligible Ages||N/A and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fundación Academia Española de Dermatología|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Esteban Daudén, PhD|
|Principal Investigator Affiliation||Hospital de La Princesa- Madrid|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
The Spanish Registry for Adverse Events of Biological Therapies in Dermatology (BIOBADADERM) was launched in October 2008, as a pharmacovigilance effort for psoriatic patients. The registry is managed by the Foundation of the Spanish Academy of Dermatology and Venereology (AEDV). BIOBADADERM has been promoted by the AEDV, in collaboration with the Spanish Agency for Medicines and Health Products (AEMPS) and the Research Unit of the Spanish Foundation of Rheumatology (FER) and the Research Unit of the Fundacion AEDV. BIOBADADERM is part of PSONET, a European network for sharing data from records of patients treated with biologics. BIOBADADERM is a prospective cohort of patients receiving biologic drugs that can be compared with another cohort of patients receiving other systemic treatments. One of the cohorts is made up of all consecutive psoriasis patients who begin any biological therapy (including infliximab (INF), etanercept (ET), efalizumab (EFA), adalimumab (ADA), rituximab (RTX) and ustekinumab (UTK)) in each centre. The control cohort consists of psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (methotrexate, cyclosporine or acitretin). The objectives of BIOBADADERM are:
- - Identify adverse events (AEs) occurring during the relevant treatment with biologic therapies, and estimate their frequency; - Identify unexpected AEs, particularly those that may occur after long periods of exposure; - Identify relevant AEs that arise after discontinuation of treatment; - Estimate the relative risk of developing AEs with biologic therapies in patients with psoriasis compared to psoriatic patients exposed to other systemic (non-biological); and - Identify risk factors for AEs in patients with these treatments.
: New drugs
Cohort exposed to biologic therapy, apremilast or fumarates
: Classic systemic therapy
Non-biological systemic treatment (methotrexate, cyclosporine and acitretin) Phototherapy was accepted as systemic therapy only in the small group of patients retrospectively included(PUVA, UVB 311).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.