TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

Sponsor
University Hospital, Gentofte, Copenhagen
Study ID
NCT01657513
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 - 1. infliximab or 2. adalimumab or 3. etanercept The consulting dermatologist decides which drug to use according to official guidelines

Study Details

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.

Key Dates

Start date
Jun 30, 2012
Status verified
Aug 2012
Primary completion
Jul 31, 2013

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

change in concentration of tnf-alfa antibodies in serum [ Time Frame: 3, 6, and 12 months after start of tnf-alfa blocking agent ]

Central Contacts

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