TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
NCT ID: NCT01657513
Last Updated: 2012-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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 -
1. infliximab or
2. adalimumab or
3. etanercept
The consulting dermatologist decides which drug to use according to official guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 -
1. infliximab or
2. adalimumab or
3. etanercept
The consulting dermatologist decides which drug to use according to official guidelines
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age above 18
* Psoriasis
* Indication for treatment with tnf alfa blocking drug
* Written informed consent obtained
Exclusion Criteria
* No indication for treatment with tnf-alfa blocking drug
* Pregnancy
* Breastfeeding
* No written informed consent
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Michaelsen Foundation
UNKNOWN
Pfizer
INDUSTRY
University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Jensen
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lone Skov, MD, PhD
Role: STUDY_DIRECTOR
Copenhagen University Hospital Gentofte, Department of Skin and Allergies
Mona Ståhle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institute, Department of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copenhagen University Hospital Gentofte, Department of Skin and Allergies
Hellerup, , Denmark
Karolinska Institute, Department of Medicine
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lone Skov, MD, PhD
Role: primary
Peter Jensen, MD
Role: backup
Mona Ståhle, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-2-2012-001
Identifier Type: REGISTRY
Identifier Source: secondary_id
H-2-2012-001
Identifier Type: -
Identifier Source: org_study_id