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UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis

Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00638469
Enrollment
10
Registered
2008-03-19
Start date
2008-03-31
Completion date
2014-12-31
Last updated
2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, Biologic, adalimumab, narrowband UVB, phototherapy, half-side comparison

Brief summary

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.

Detailed description

Patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter one a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to \< 3) for a maximum of another 6 weeks (until week 12). PASI score, visual analogue score (VAS) patient score for therapeutic response, and VAS patient score 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.

Interventions

RADIATIONUVB-311nm

UVB-311nm radiation given 3 times a week to one randomized body half

OTHERNo treatment

no UV exposure

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Psoriasis patients with PASI reduction of less than 75% after at least 6 weeks of 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

Design outcomes

Primary

MeasureTime frame
Modified PASI (psoriasis area and severity index)12 months

Secondary

MeasureTime frame
VAS patient score for therapeutic effect12 months
VAS patient score for severity of skin lesions12 months

Countries

Austria

Contacts

Primary ContactPeter Wolf, MD
peter.wolf@medunigraz.at+43 316 385
Backup ContactAngelika Hofer, MD
angelika.hofer@medunigraz.at+43 316 385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026