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Trial record 1 of 1 for:    NCT01657513
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TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

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ClinicalTrials.gov Identifier: NCT01657513
Recruitment Status : Unknown
Verified August 2012 by Peter Jensen, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
First Posted : August 6, 2012
Last Update Posted : August 6, 2012
Sponsor:
Collaborators:
The Michaelsen Foundation
Pfizer
Information provided by (Responsible Party):
Peter Jensen, University Hospital, Gentofte, Copenhagen

Tracking Information
First Submitted Date  ICMJE July 30, 2012
First Posted Date  ICMJE August 6, 2012
Last Update Posted Date August 6, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
change in concentration of tnf-alfa antibodies in serum [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]
Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
  • change in severity of psoriasis, PASI [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]
    severity of psoriasis assessed by PASI
  • Presence of psoriatic arthritis [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]
    Does the patient have psoriasis arthritis
  • change in dermatology life quality index (DLQI) [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]
    psoriasis severity assessed by the dermatology life quality index (DLQI)
  • height (cm) [ Time Frame: 3 months ]
    subject´s height in centimeters
  • change in weight (kg) [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]
    subjects weight in kilograms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2012)
assessment of change in concentrations of other biomarkers of interest in psoriasis [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]
Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest
Original Other Pre-specified Outcome Measures Same as current
 
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, PhD Copenhagen University Hospital Gentofte, Department of Skin and Allergies
Principal Investigator: Mona Ståhle, MD, PhD Karolinska 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