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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

DRKS00000716.

Methods Randomised, active‐controlled, parallel‐group, simple blind
Date of study: 3 June 2008 (starting date)
Location: Germany
Participants Inclusion criteria
  • Aged 18 ‐ 65 years

  • Clinical diagnosis of psoriasis for > 6 months

  • Plaque‐type psoriasis (PASI > 10)

  • BSA > 10%


Exclusion criteria
  • Contraindications for treatment with TNF‐alpha inhibitors and FAEs

  • Women who are pregnant or who are breast‐feeding. Women of childbearing potential must follow a medically recognised form of contraception

  • Currently receiving or have received within 4 weeks prior to first administration of study administration: systemic therapy for psoriasis; monoclonal antibody therapy for psoriasis; phototherapy

  • TB anamnesis, infections (Hepatitis B, C, HIV)

  • History of lymphoproliferative disorders, malignancies, demyelinating disease, severe heart failure

  • History of substance abuse (drugs or alcohol) or any factor (e.g. serious psychiatric condition) which limits the patient’s ability to co‐operate with the study procedures

  • Unco‐operative, known to miss appointments (according to patient’s records) and are unlikely to follow medical instructions or are not willing to attend regular visits

Interventions
  • Arm 1: Adalimumab (Humira): 80mg initial puis 40mg /2 weeks 24 weeks

  • Arm 2: Etanercept (Enbrel): 50mg 2x/weeks s.c. 12 weeks puis 25mg 2x/weeks s.c. 12 weeks

  • Arm 3: Fumaderm

Outcomes Week 8:
PASI
DLQI
Immunhistologie
Week 24:
PASI
DLQI
Immunhistologie
Notes Starting date: 03 June 2008, Prof. Arnd Jacobi, Klinik für Dermatologie und Allergologie Philipps‐Universität Marburg
Recruitment status on ICTRP search portal: complete: follow‐up complete
We emailed Prof. Jacobi (5 January 2017) without response