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| ID | Type | Description | Link |
|---|---|---|---|
| H-2-2012-001 | Registry Identifier | Ethics committee of the Capital Region of Denmark |
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| Name | Class |
|---|---|
| The Michaelsen Foundation | UNKNOWN |
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tnf-alfa treatment (infliximab, adalimumab, or etanercept) | Experimental | This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subjects will receive either infliximab, adalimumab or etanercept | Drug | 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 -
The consulting dermatologist decides which drug to use according to official guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| change in concentration of tnf-alfa antibodies in serum | Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies | 3, 6, and 12 months after start of tnf-alfa blocking agent |
| Measure | Description | Time Frame |
|---|---|---|
| change in severity of psoriasis, PASI | severity of psoriasis assessed by PASI | 3, 6, and 12 months after start of tnf-alfa blocking agent |
| Presence of psoriatic arthritis | Does the patient have psoriasis arthritis |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of change in concentrations of other biomarkers of interest in psoriasis | Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest | 3, 6, and 12 months after start of tnf-alfa blocking agent |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lone Skov, MD, PhD | Contact | +4539773204 | lone.skov.02@regionh.dk | |
| Peter Jensen, MD | Contact | +4539777538 | peter.jensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lone Skov, MD, PhD | Copenhagen University Hospital Gentofte, Department of Skin and Allergies | Study Director |
| Mona Ståhle, MD, PhD | Karolinska Institute, Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Gentofte, Department of Skin and Allergies | Recruiting | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 3, 6, and 12 months after start of tnf-alfa blocking agent |
| change in dermatology life quality index (DLQI) | psoriasis severity assessed by the dermatology life quality index (DLQI) | 3, 6, and 12 months after start of tnf-alfa blocking agent |
| height (cm) | subject´s height in centimeters | 3 months |
| change in weight (kg) | subjects weight in kilograms | 3, 6, and 12 months after start of tnf-alfa blocking agent |
| Karolinska Institute, Department of Medicine | Recruiting | Stockholm | 17177 | Sweden |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |