| March 12, 2008 |
| September 29, 2009 |
| March 2008 |
| December 2009 (final data collection date for primary outcome measure) |
| Modified PASI (psoriasis area and severity index) [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00638469 on ClinicalTrials.gov Archive Site |
- VAS patient score for therapeutic effect [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- VAS patient score for severity of skin lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| 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 |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Psoriasis |
- Radiation: UVB-311nm
- Other: No treatment
|
| Other: left or right body side |
| |
| |
| Recruiting |
| 10 |
| December 2010 |
| December 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Austria |
| |
| NCT00638469 |
| Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria |
| 19-133 ex 07/08 |
| Medical University of Graz |
|
| Principal Investigator: |
Peter Wolf, MD |
Medical University of Graz, Austria |
|
|
| Medical University of Graz |
| September 2009 |
