L40.0
Conditions
Interventions
Group 1: Adalimumab (Humira) was applied with 80mg initially and 40mg every other week subcutaneously over a time period of 24 weeks.
Group 2: Etanercept (Enbrel) was given 50mg twice weekly subcutane
Sponsors
Universitätsklinikum Gießen und Marburg, Standort Marburg
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| week 24: PASI: clinical score of skin lesions; DLQI: dermatology life quality index; skin biopsy: immunohistology; T cells in peripheral blood | — |
Primary
| Measure | Time frame |
|---|---|
| week 8: PASI: clinical score of skin lesions; DLQI: dermatology life quality index; skin biopsy: immunohistology; T cells in peripheral blood | — |
Countries
Germany
Contacts
Public ContactArnd Jacobi
Klinik für Dermatologie und Allergologie Philipps-Universität Marburg
Outcome results
None listed