Golimumab Plus UVB-311nm in Psoriasis

This study is currently recruiting participants.
Verified October 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01088698
First received: March 15, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Psoriasis
Radiation: UVB-311nm radiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study of the Combination of Golimumab and UVB-311nm Phototherapy in Patients With Psoriatic Arthritis and Psoriatic Skin Lesions

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: UVB-311nm radiation
    UVB-311nm radiation given 3 times a week to one randomized body-half
    Other Name: narrow-band UVB radiation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088698

Contacts
Contact: Peter Wolf, MD +43 316 385 ext 80315 peter.wolf@medunigraz.at
Contact: Franz Legat, MD +43 316 385 ext 13254 franz.legat@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Peter Wolf, MD    +43 316 385 ext 80315    peter.wolf@medunigraz.at   
Contact: Franz Legat, MD    +43 316 385 ext 13254    franz.legat@medunigraz.at   
Sub-Investigator: Alexandra Gruber-Wackernagel, MD         
Sub-Investigator: Angelika Hofer, MD         
Sub-Investigator: Franz Legat, MD         
Sub-Investigator: Wolfgang Salmhofer, MD         
Sub-Investigator: Wolfgang Weger, MD         
Sub-Investigator: Winfried Graninger, MD         
Sub-Investigator: Christian Dejaco, MD, PhD         
Sub-Investigator: Josef Hermann, MD         
Principal Investigator: Peter Wolf, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz, Austria
  More Information

No publications provided

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01088698     History of Changes
Other Study ID Numbers: 21-110 ex 09/10
Study First Received: March 15, 2010
Last Updated: October 31, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
psoriasis
golimumab
TNF-alpha inhibition
phototherapy
311-nm

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014