TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
NCT01657513
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- Male or female
- Age above 18
- Psoriasis
- Indication for treatment with tnf alfa blocking drug
- Written informed consent obtained
- Severe psychiatric disorder
- No indication for treatment with tnf-alfa blocking drug
- Pregnancy
- Breastfeeding
- No written informed consent
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis | ||||||
| Official Title ICMJE | Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis | ||||||
| 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Psoriasis | ||||||
| Intervention ICMJE | 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:
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| Study Arms ICMJE | 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 Intervention: Drug: subjects will receive either infliximab, adalimumab or etanercept | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE | 60 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Study Completion Date ICMJE | Not Provided | ||||||
| Estimated Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Denmark, Sweden | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01657513 | ||||||
| Other Study ID Numbers ICMJE | H-2-2012-001 H-2-2012-001 ( Registry Identifier: Ethics committee of the Capital Region of Denmark ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Peter Jensen, University Hospital, Gentofte, Copenhagen | ||||||
| Study Sponsor ICMJE | University Hospital, Gentofte, Copenhagen | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University Hospital, Gentofte, Copenhagen | ||||||
| Verification Date | August 2012 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||