Trial record 6 of 1267 for:
TNF
TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
This study is currently recruiting participants.
Verified August 2012 by University Hospital, Gentofte, Copenhagen
Sponsor:
University Hospital, Gentofte, Copenhagen
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
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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 -
The consulting dermatologist decides which drug to use according to official guidelines Other Names:
|
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
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, Papulosquamous Skin Diseases Antibodies TNFR-Fc fusion protein Infliximab Adalimumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Central Nervous System Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013