UVB-311nm After Initial Slow Response to Adalimumab in Ps... | NCT00638469

Studies
UVB-311nm After Initial Slow Response to Adalimumab in Psoriasis

NCT00638469

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Nov 1, 2013Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Psoriasis

Interventions

UVB-311nm
No treatment

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Mar 12, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2013

Last Update Posted Date

Nov 1, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of GrazPrincipal Investigator

Lead Sponsor

Medical University of GrazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of psoriatic lesions in adalimumab-treated patients after initial slow response.

Detailed Description

Patients with moderate to severe psoriasis who have received treatment with adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Adalimumab is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter one a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to < 3) for a maximum of another 6 weeks (until week 12). PASI score, visual analogue score (VAS) patient score for therapeutic response, and VAS patient score for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between body sites.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
left/right	Other	left or right body side	Radiation: UVB-311nm Other: No treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UVB-311nm	Radiation	UVB-311nm radiation given 3 times a week to one randomized body half	left/right

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified PASI (psoriasis area and severity index)		12 months

Secondary Outcomes

Measure	Description	Time Frame
VAS patient score for therapeutic effect		12 months
VAS patient score for severity of skin lesions		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Psoriasis patients with PASI reduction of less than 75% after at least 6 weeks of treatment with adalimumab.

Exclusion Criteria:

Pregnancy or lactation
History of skin cancer
Presence of or history of malignant skin tumors
Dysplastic melanocytic nevus syndrome
Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
General poor health status

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Wolf, MD	Contact	+43 316 385	80315	peter.wolf@medunigraz.at
Angelika Hofer, MD	Contact	+43 316 385	80315	angelika.hofer@medunigraz.at

Overall Officials

Name	Affiliation	Role
Peter Wolf, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz, Department of Dermatology	Recruiting	Graz		A-8036	Austria

Type	Date	Date Unknown
Release	Oct 27, 2017
Reset	Aug 3, 2018

Submission Tracking

Estimated Results First Submitted Date

Oct 27, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 27, 2017			Aug 3, 2018

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

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Browse Branches

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