TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Michaelsen Foundation
Pfizer
Information provided by (Responsible Party):
Peter Jensen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01657513
First received: July 30, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Psoriasis
Drug: subjects will receive either infliximab, adalimumab or etanercept

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • change in concentration of tnf-alfa antibodies in serum [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ] [ Designated as safety issue: No ]
    Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies


Secondary Outcome Measures:
  • change in severity of psoriasis, PASI [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ] [ Designated as safety issue: No ]
    severity of psoriasis assessed by PASI

  • Presence of psoriatic arthritis [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    psoriasis severity assessed by the dermatology life quality index (DLQI)

  • height (cm) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    subject´s height in centimeters

  • change in weight (kg) [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ] [ Designated as safety issue: No ]
    subjects weight in kilograms


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657513

Contacts
Contact: Lone Skov, MD, PhD +4539773204 lone.skov.02@regionh.dk
Contact: Peter Jensen, MD +4539777538 peter.jensen@regionh.dk

Locations
Denmark
Copenhagen University Hospital Gentofte, Department of Skin and Allergies Recruiting
Hellerup, Denmark, 2900
Contact: Lone Skov, MD, PhD    +4539773204    lone.skov.02@regionh.dk   
Contact: Peter Jensen, MD    +4539777538    peter.jensen@regionh.dk   
Principal Investigator: Lone Skov, MD, PhD         
Sub-Investigator: Peter Jensen, MD         
Sub-Investigator: Claus Zachariae, MD, PhD         
Sweden
Karolinska Institute, Department of Medicine Recruiting
Stockholm, Sweden, 17177
Contact: Mona Ståhle, MD, PhD       mona.stahle@ki.dk   
Principal Investigator: Mona Ståhle, MD, PhD         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
The Michaelsen Foundation
Pfizer
Investigators
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
  More Information

No publications provided

Responsible Party: Peter Jensen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01657513     History of Changes
Other Study ID Numbers: H-2-2012-001, H-2-2012-001
Study First Received: July 30, 2012
Last Updated: August 3, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
psoriasis
treatment failure
tnf-alfa

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Infliximab
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014