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

March 15, 2010
June 23, 2014
March 2010
October 2010   (final data collection date for primary outcome measure)
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.
Psoriasis area and severity index (PASI) reduction [ Time Frame: 12 months ] [ 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 reduction of PASI by > 20% compared to the untreated body site at week 6 of the study.
Complete list of historical versions of study NCT01088698 on ClinicalTrials.gov Archive Site
Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Patient visual analogue (VAS) score for the therapeutic effect and severity of skin lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
Radiation: UVB-311nm radiation
UVB-311nm radiation given 3 times a week to one randomized body-half
Other Name: narrow-band UVB radiation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01088698
21-110 ex 09/10
No
Peter Wolf, MD, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Peter Wolf, MD Medical University of Graz, Austria
Medical University of Graz
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP