| October 24, 2007 |
| September 29, 2009 |
| August 2006 |
| December 2009 (final data collection date for primary outcome measure) |
| Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ] [ Designated as safety issue: No ] |
| Reduction of PASI (psoriasis activity score index) [ Time Frame: prospective ] |
| Complete list of historical versions of study NCT00550030 on ClinicalTrials.gov Archive Site |
| Patient disease and life quality score [ Time Frame: prospective ] [ Designated as safety issue: No ] |
| Patient disease and life quality score [ Time Frame: prospective ] |
| |
| Etanercept Plus UVB-311nm Phototherapy in Psoriasis |
| Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment |
Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept. |
Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on 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 and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality 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, Dose Comparison, Single Group Assignment, Efficacy Study |
| Psoriasis |
- Radiation: UVB-311nm radiation
- Other: No treatment
|
| Experimental: half-body comparison |
| |
| |
| Recruiting |
| 17 |
| December 2010 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater
Exclusion Criteria:
- Pregnancy or lactation
- 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 |
| |
| NCT00550030 |
| Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria |
| 17-257 ex 05/06 |
| Medical University of Graz |
|
| Principal Investigator: |
Peter Wolf, MD |
Dept. of Dermatology, Medical University of Graz, Graz, Austria |
|
|
| Medical University of Graz |
| September 2009 |