Golimumab Plus UVB-311nm in Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088698
Recruitment Status : Terminated (Difficulties in recruiting patients;)
First Posted : March 17, 2010
Last Update Posted : June 24, 2014
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Psoriasis Radiation: UVB-311nm radiation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Golimumab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Psoriasis area and severity index (PASI) reduction from baseline comparing the UV-irradiated vs. the non-irradiated body site [ Time Frame: week 6 ]
    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 :
  1. Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088698

Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Peter Wolf, MD Medical University of Graz, Austria

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz Identifier: NCT01088698     History of Changes
Other Study ID Numbers: 21-110 ex 09/10
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Peter Wolf, MD, Medical University of Graz:
TNF-alpha inhibition

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases