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:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT04870827
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects of both genders will be considered for inclusion in this study. There will be no racial, ethnic, or gender discrimination.
Affected Subjects:
* 18 years of age or older
* Diagnosed with moderate-severe psoriasis clinically confirmed by a licensed physician, or advanced practitioner consisting of typical skin findings and/or associated findings of systemic disease of joints, nails, and hair and may be scheduled to initiate biologic
treatment for psoriasis
Healthy Controls:
Females and males 18 years of age or older
EXCLUSION CRITERIA:
Affected Subjects:
* Pregnant or lactating women
* Subjects with a contraindication to MRI scanning will not receive the CMR assessment.
These contraindications include subjects with the following devices:
i. Central nervous system aneurysm clips
ii. Implanted neural stimulator
iii. Implanted cardiac pacemaker or defibrillator
iv. Cochlear implant
v. Ocular foreign body (e.g. metal shavings)
vi. Implanted Insulin pump
vii. Metal shrapnel or bullet
viii. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2 body surface area according to the Modification of Diet in Renal Disease criteria
* History of seizures or taking anti-epileptic medications
* Inability to provide informed consent
Healthy Controls:
* Diagnosis of inflammatory disease (including psoriasis, psoriatic arthritis, rheumatoid arthritis, lupus, inflammatory bowel disease)
* Pregnant women and lactating women
* Subjects with a contraindication to MRI scanning will not receive the CMR assessment.
These contraindications include subjects with the following devices:
ix. Central nervous system aneurysm clips
x. Implanted neural stimulator
xi. Implanted cardiac pacemaker or defibrillator
xii. Cochlear implant
xiii. Ocular foreign body (e.g. metal shavings)
xiv. Implanted Insulin pump
xv. Metal shrapnel or bullet
xvi. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2 body surface area according to the Modification of Diet in Renal Disease criteria
* History of seizures or taking anti-epileptic medications
* Inability to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04870827
Study Brief:
Protocol Section:
NCT04870827