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TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

NCT01657513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-08-06

No results posted yet for this study

Summary

TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects.

Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration.

The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.

Conditions

Interventions

DRUG

subjects will receive either infliximab, adalimumab or etanercept

The subjects receive treatment with a tnf-alfa blocking according to the official guidelines for the particular drug. The study subjects will receive treatment with one drug only - 1. infliximab or 2. adalimumab or 3. etanercept The consulting dermatologist decides which drug to use according to official guidelines

Sponsors & Collaborators

  • The Michaelsen Foundation

    collaborator UNKNOWN

  • Pfizer

    collaborator INDUSTRY

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Lone Skov, MD, PhD · Copenhagen University Hospital Gentofte, Department of Skin and Allergies

  • Mona Ståhle, MD, PhD · Karolinska Institute, Department of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-07-31

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01657513 on ClinicalTrials.gov