Regulatory T-cell function in psoriasis vulgaris

Not Applicable

• Conditions: L40.0; Psoriasis vulgaris

• Registration Number: DRKS00000716
• Lead Sponsor: niversitätsklinikum Gießen und Marburg, Standort Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-10-03
• Study Start: 2011-02-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

•who are aged 18 years up to 65 years
•clinical diagnosis of psoriasis for >6 month
•who have plaque-type psoriasis (PASI>10)
•psoriasis affected body surface >10%
•who have been informed of the study procedures and medication and have provided written informed consent

Exclusion Criteria

•patients with contraindications for treatment with TNF-alpha inhibitors and fumaric acid esters;
women who are pregnant or who are breast-feeding. Women of child-bearing potential must follow a medically recognized form of contraception
•who are currently receiving or have received systemic therapy for psoriasis within four weeks prior to the first administration of study medication.
•who are currently receiving or have received monoclonal antibody therapy for psoriasis within four weeks to the first administration of study medication.
•who are currently receiving or have received phototherapy within four weeks prior to the first administration of study medication.
•tuberculosis anamnesis, infections (Hepatitis B, C, HIV)
•with a history of lymphoproliferative disorders, malignancies, demyelinating disease, severe heart failure
•who have a history of substance abuse (drugs or alcohol) or any factor (e.g. serious psychiatric condition) which limits the patient’s ability to cooperate with the study procedures
•who are uncooperative, known to miss appointments (according to patient’s records) and are unlikely to follow medical instructions or are not willing to attend regular visits

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
week 8:<br>PASI: clinical score of skin lesions;<br>DLQI: dermatology life quality index;<br>skin biopsy: immunohistology;<br>T cells in peripheral blood

Secondary Outcome Measures

Name	Time	Method
week 24:<br>PASI: clinical score of skin lesions;<br>DLQI: dermatology life quality index;<br>skin biopsy: immunohistology;<br>T cells in peripheral blood