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Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

18 Years
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Trial Information

Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis

Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment
course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed
to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per
week for six weeks and/or until complete response (defined as reduction in PASI to < 3).
PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS
for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and
12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer
exact test is applied to determine differences in complete remission, PASI reduction > 90%,
> 75% and/or 50% between body sites.

Inclusion Criteria:

- Psoriasis patients who are scheduled for treatment with adalimumab.

Exclusion Criteria:

- Pregnancy or lactation

- History of skin cancer

- Presence of or history of malignant skin tumors

- Dysplastic melanocytic nevus syndrome

- Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)

- Autoimmune disorders such as Lupus erythematosus or Dermatomyositis

- Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma
pigmentosum, basal cell nevus syndrome, and others

- General poor health status

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Modified PASI (psoriasis area and severity index)

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Peter Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Graz, Austria


Austria: Federal Ministry for Health and Women

Study ID:

19-134 ex 07/08



Start Date:

March 2008

Completion Date:

August 2011

Related Keywords:

  • Psoriasis
  • Psoriasis
  • Biologic
  • Adalimumab
  • Narrow-band UVB
  • phototherapy
  • half-side comparison
  • Psoriasis