Back to resultsTNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
subjects will receive either infliximab, adalimumab or etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, treatment failure, tnf-alfa
Eligibility 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
Sites / Locations
- Copenhagen University Hospital Gentofte, Department of Skin and AllergiesRecruiting
- Karolinska Institute, Department of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tnf-alfa treatment (infliximab, adalimumab, or etanercept)
Arm Description
This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug
Outcomes
Primary Outcome Measures
change in concentration of tnf-alfa antibodies in serum
Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies
Secondary Outcome Measures
change in severity of psoriasis, PASI
severity of psoriasis assessed by PASI
Presence of psoriatic arthritis
Does the patient have psoriasis arthritis
change in dermatology life quality index (DLQI)
psoriasis severity assessed by the dermatology life quality index (DLQI)
height (cm)
subject´s height in centimeters
change in weight (kg)
subjects weight in kilograms
Full Information
NCT ID
NCT01657513
First Posted
July 30, 2012
Last Updated
August 3, 2012
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
The Michaelsen Foundation, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01657513
Brief Title
TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
Official Title
Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
The Michaelsen Foundation, Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, treatment failure, tnf-alfa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tnf-alfa treatment (infliximab, adalimumab, or etanercept)
Arm Type
Experimental
Arm Description
This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug
Intervention Type
Drug
Intervention Name(s)
subjects will receive either infliximab, adalimumab or etanercept
Other Intervention Name(s)
infliximab, adalimumab, etanercept
Intervention Description
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 -
infliximab or
adalimumab or
etanercept
The consulting dermatologist decides which drug to use according to official guidelines
Primary Outcome Measure Information:
Title
change in concentration of tnf-alfa antibodies in serum
Description
Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies
Time Frame
3, 6, and 12 months after start of tnf-alfa blocking agent
Secondary Outcome Measure Information:
Title
change in severity of psoriasis, PASI
Description
severity of psoriasis assessed by PASI
Time Frame
3, 6, and 12 months after start of tnf-alfa blocking agent
Title
Presence of psoriatic arthritis
Description
Does the patient have psoriasis arthritis
Time Frame
3, 6, and 12 months after start of tnf-alfa blocking agent
Title
change in dermatology life quality index (DLQI)
Description
psoriasis severity assessed by the dermatology life quality index (DLQI)
Time Frame
3, 6, and 12 months after start of tnf-alfa blocking agent
Title
height (cm)
Description
subject´s height in centimeters
Time Frame
3 months
Title
change in weight (kg)
Description
subjects weight in kilograms
Time Frame
3, 6, and 12 months after start of tnf-alfa blocking agent
Other Pre-specified Outcome Measures:
Title
assessment of change in concentrations of other biomarkers of interest in psoriasis
Description
Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest
Time Frame
3, 6, and 12 months after start of tnf-alfa blocking agent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lone Skov, MD, PhD
Phone
+4539773204
Email
lone.skov.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Jensen, MD
Phone
+4539777538
Email
peter.jensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lone Skov, MD, PhD
Organizational Affiliation
Copenhagen University Hospital Gentofte, Department of Skin and Allergies
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mona Ståhle, MD, PhD
Organizational Affiliation
Karolinska Institute, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Gentofte, Department of Skin and Allergies
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lone Skov, MD, PhD
Phone
+4539773204
Email
lone.skov.02@regionh.dk
First Name & Middle Initial & Last Name & Degree
Peter Jensen, MD
Phone
+4539777538
Email
peter.jensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Lone Skov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Peter Jensen, MD
First Name & Middle Initial & Last Name & Degree
Claus Zachariae, MD, PhD
Facility Name
Karolinska Institute, Department of Medicine
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Ståhle, MD, PhD
Email
mona.stahle@ki.dk
First Name & Middle Initial & Last Name & Degree
Mona Ståhle, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
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