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.
|Eligible Ages||18 Years and Over|
- - Adult male and female (≥ 18 years).
- - Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet - Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
- - Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
- - All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
- - Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis.
- - Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis.
- - Patients who agree to participate in the study by signing the informed consent.
- - Patients who are able to understand and complete the questionnaires specified in the study protocol.
Exclusion Criteria:• Patients participating in another study at the time of entering the study.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Amgen|
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|
: Patients with plaque psoriasis on apremilast
Adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice.
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.