Golimumab Plus UVB-311nm in Psoriasis

Psoriasis Clinical Trial

Official title:

Prospective Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01088698
• Other study ID #: 21-110 ex 09/10
• Status: Terminated
• Phase: N/A
• First received: March 15, 2010
• Last updated: June 23, 2014
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: June 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patients with psoriatic arthritis who receive treatment with golimumab

• Patient wish for treatment of psoriatic skin lesions

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Radiation:
• UVB-311nm radiation
UVB-311nm radiation given 3 times a week to one randomized body-half

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions		week 6	No