Psoriasis
Conditions
Keywords
psoriasis, treatment failure, tnf-alfa
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.
Interventions
DRUGsubjects 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
The Michaelsen Foundation
Pfizer
University Hospital, Gentofte, Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in concentration of tnf-alfa antibodies in serum | 3, 6, and 12 months after start of tnf-alfa blocking agent | Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in severity of psoriasis, PASI | 3, 6, and 12 months after start of tnf-alfa blocking agent | severity of psoriasis assessed by PASI |
| Presence of psoriatic arthritis | 3, 6, and 12 months after start of tnf-alfa blocking agent | Does the patient have psoriasis arthritis |
| height (cm) | 3 months | subject´s height in centimeters |
| change in weight (kg) | 3, 6, and 12 months after start of tnf-alfa blocking agent | subjects weight in kilograms |
| change in dermatology life quality index (DLQI) | 3, 6, and 12 months after start of tnf-alfa blocking agent | psoriasis severity assessed by the dermatology life quality index (DLQI) |
Other
| Measure | Time frame | Description |
|---|---|---|
| assessment of change in concentrations of other biomarkers of interest in psoriasis | 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 |
Countries
Denmark, Sweden
Contacts
Primary ContactLone Skov, MD, PhD
Backup ContactPeter Jensen, MD
Outcome results
None listed