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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01356758
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 18 years or above.
2. Intervention group: Severe plaque psoriasis with indication for biological therapy according to national guidelines. Psoriasis Control group: Patients with similar disease activity who for personal reasons decline systemic treatment and only receive topical therapy. Atopic dermatitis group: Patients matched regarding sex, disease duration, body surface involvement, BMI and smoking habits.
3. Signed informed consent form prior to initiation of any study-mandated procedure.
Exclusion Criteria:
1. Significant arterial hypertension, unless well controlled with anti-hypertensive medication for at least 1 month before inclusion.
2. Lipid-lowering treatment, unless well controlled for at least 1 month before inclusion.
3. Congestive heart failure (NYHA group III and IV).
4. Reduced kidney function (eGFR below 60).
5. Oral methotrexate, ciclosporin, acitretin and fumarate esters within 1 month before inclusion. In the intervention group, patients receiving oral anti-psoriatic treatment for at least 6 months before the study start can be included, if they are maintained on the same dose during the study period.
6. UVB phototherapy and PUVA photochemotherapy within 1 month prior to study start.
7. Prior treatment with infliximab, etanercept, adalimumab or ustekinumab unless less than PASI-50% reduction have been observed during this treatment.
8. Investigational biological agents within 6 months prior to inclusion.
9. Any other investigational drug within 1 month or 5 half lives prior to inclusion, which ever is longer.
10. Concurrent immunosuppressive or anti-inflammatory treatment for immune diseases other than psoriasis and psoriatic arthritis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01356758
Study Brief:
Protocol Section:
NCT01356758