Golimumab Plus UVB-311nm in Psoriasis
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| First Received Date ICMJE | March 15, 2010 | ||||||||
| Last Updated Date | February 12, 2013 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site [ Time Frame: week 6 ] [ Designated as safety issue: No ] The effect of treatment on PASI will be determined. The primary hypothesis is that UVB-311nm treatment leads to a difference in the reduction of PASI from baseline by > 20% comparing the UV-irradiated vs. the non-irradiated body site at week 6 of treatment. |
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| Original Primary Outcome Measures ICMJE |
Psoriasis area and severity index (PASI) reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ] The effect of treatment on PASI will be determined. The primary hypothesis is that UVB-311nm treatment leads to a reduction of PASI by > 20% compared to the untreated body site at week 6 of the study. |
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| Change History | Complete list of historical versions of study NCT01088698 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: week 6 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Golimumab Plus UVB-311nm in Psoriasis | ||||||||
| Official Title ICMJE | Prospective Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions | ||||||||
| Brief Summary | Golimumab, a TNF-alpha antibody, has been approved in the EC and USA for the treatment of psoriatic arthritis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic skin lesions in golimumab-treated patients. |
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| Detailed Description | Psoriatic skin lesions of patients with psoriatic arthritis who receive standard treatment with golimumab (50 mg or 100 mg s.c. once a month depending on total body weight whether below or above 100 kg, respectively) 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). A patient qualifies if A) golimumab was started within a week or B) after 3 months of golimumab treatment the PASI reduction is smaller than 90%. 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. The primary hypothesis is that phototherapy increases the PASI reduction on the exposed body site by more than 20%. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fisher exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between body sites. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Psoriasis | ||||||||
| Intervention ICMJE | Radiation: UVB-311nm radiation
UVB-311nm radiation given 3 times a week to one randomized body-half
Other Name: narrow-band UVB radiation |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01088698 | ||||||||
| Other Study ID Numbers ICMJE | 21-110 ex 09/10 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Peter Wolf, MD, Medical University of Graz | ||||||||
| Study Sponsor ICMJE | Medical University of Graz | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Graz | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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