TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

NCT01657513

Last updated date
Study Location
Copenhagen University Hospital Gentofte, Department of Skin and Allergies
Hellerup, , 2900, Denmark
Contact
+4539773204

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

+4539773204

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female

- Age above 18

- Psoriasis

- Indication for treatment with tnf alfa blocking drug

- Written informed consent obtained

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe psychiatric disorder


- No indication for treatment with tnf-alfa blocking drug


- Pregnancy


- Breastfeeding


- No written informed consent

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Advanced Information
Descriptive Information
Brief Title  ICMJE TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
Official Title  ICMJE Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE 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

Other Names:
  • infliximab
  • adalimumab
  • etanercept
Study Arms  ICMJE Experimental: tnf-alfa treatment (infliximab, adalimumab, or etanercept)
This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug
Intervention: Drug: subjects will receive either infliximab, adalimumab or etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 3, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • Age above 18
  • Psoriasis
  • Indication for treatment with tnf alfa blocking drug
  • Written informed consent obtained

Exclusion Criteria:

  • Severe psychiatric disorder
  • No indication for treatment with tnf-alfa blocking drug
  • Pregnancy
  • Breastfeeding
  • No written informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01657513
Other Study ID Numbers  ICMJE H-2-2012-001
H-2-2012-001 ( Registry Identifier: Ethics committee of the Capital Region of Denmark )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Jensen, University Hospital, Gentofte, Copenhagen
Study Sponsor  ICMJE University Hospital, Gentofte, Copenhagen
Collaborators  ICMJE
  • The Michaelsen Foundation
  • Pfizer
Investigators  ICMJE
Study Director:Lone Skov, MD, PhDCopenhagen University Hospital Gentofte, Department of Skin and Allergies
Principal Investigator:Mona Ståhle, MD, PhDKarolinska Institute, Department of Medicine
PRS Account University Hospital, Gentofte, Copenhagen
Verification Date August 2012

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