Golimumab Plus UVB-311nm in Psoriasis

This study has been terminated.
(Difficulties in recruiting patients;)
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01088698
First received: March 15, 2010
Last updated: June 23, 2014
Last verified: June 2014
  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
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Medical University of Graz
Graz, Austria, 8036
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: June 23, 2014
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 July 23, 2014