Study Stopped
Difficulties in recruiting patients;
Golimumab Plus UVB-311nm in Psoriasis
Prospective Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 24, 2014
June 1, 2014
7 months
March 15, 2010
June 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site
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.
week 6
Secondary Outcomes (1)
Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions
week 6
Interventions
UVB-311nm radiation given 3 times a week to one randomized body-half
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Patients with psoriatic arthritis who receive treatment with golimumab
- Patient wish for treatment of psoriatic skin lesions
You may not qualify if:
- Pregnancy or lactation
- Presence and/or history of malignant melanoma
- Presence and/or history of invasive squamous cell carcinoma of the skin
- Presence and/or history of more than 3 basal cell carcinomas
- Dysplastic nevus syndrome
- Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
- Autoimmune disorders such as lupus erythematosus or dermatomyositis
- Abnormal photosensitivity and photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- General poor health status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, 8036, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Wolf, MD
Medical University of Graz, Austria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Bioimmunotherapy
Study Record Dates
First Submitted
March 15, 2010
First Posted
March 17, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 24, 2014
Record last verified: 2014-06