Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT02713295
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) \>10 or PASI \>10 and DLQI \>10
* Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
* Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
* Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
* Patients with a signed informed consent document
Exclusion Criteria:
* Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
* Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
* Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
* Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
* Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02713295
Study Brief:
Protocol Section:
NCT02713295