MedDataX Logo

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

NCT ID: NCT00638469

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Psoriasis Biologic adalimumab narrowband UVB phototherapy half-side comparison

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

left/right

left or right body side

Group Type OTHER

UVB-311nm

Intervention Type RADIATION

UVB-311nm radiation given 3 times a week to one randomized body half

No treatment

Intervention Type OTHER

no UV exposure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UVB-311nm

UVB-311nm radiation given 3 times a week to one randomized body half

Intervention Type RADIATION

No treatment

no UV exposure

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

narrow-band UVB radiation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Wolf, MD

Professor of Bioimmunotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Austria

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Graz, Department of Dermatology

Graz, , Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter Wolf, MD

Role: CONTACT

Phone: +43 316 385

Email: [email protected]

Angelika Hofer, MD

Role: CONTACT

Phone: +43 316 385

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Peter Wolf, MD

Role: primary

Angelika Hofer, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-133 ex 07/08

Identifier Type: -

Identifier Source: org_study_id