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| Sponsored by: |
Medical University of Graz |
|---|---|
| Information provided by: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT00638469 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis |
Radiation: UVB-311nm Other: No treatment |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Prospective, Randomized Half-Side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis After Partial Remission to Treatment With Adalimumab |
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
left/right
left or right body side
|
Radiation: UVB-311nm
UVB-311nm radiation given 3 times a week to one randomized body half
Other: No treatment
no UV exposure
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter Wolf, MD | +43 316 385 ext 80315 | peter.wolf@meduni-graz.at |
| Contact: Angelika Hofer, MD | +43 316 385 ext 80315 | angelika.hofer@meduni-graz.at |
| Austria | |
| Medical University of Graz, Department of Dermatology | Recruiting |
| Graz, Austria, A-8036 | |
| Contact: Peter Wolf, MD +43 316 385 ext 80315 peter.wolf@meduni-graz.at | |
| Contact: Angelika Hofer, MD +43 316 385 ext 3254 angelika.hofer@meduni-graz.at | |
| Principal Investigator: Peter Wolf, MD | |
| Sub-Investigator: Angelika Hofer, MD | |
| Sub-Investigator: Franz Legat, MD | |
| Sub-Investigator: Wolfgang Salmhofer, MD | |
| Sub-Investigator: Alexandra Gruber-Wackernagel, MD | |
| Sub-Investigator: Wolfgang Weger, MD | |
| Principal Investigator: | Peter Wolf, MD | Medical University of Graz, Austria |
More Information
| Responsible Party: | Principal Investigator, Medical University of Graz, Austria ( Peter Wolf, MD ) |
| Study ID Numbers: | 19-133 ex 07/08 |
| Study First Received: | March 12, 2008 |
| Last Updated: | December 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00638469 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
|
Psoriasis Biologic adalimumab |
narrowband UVB phototherapy half-side comparison |
|
Skin Diseases Psoriasis Adalimumab Skin Diseases, Papulosquamous |
|
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |
