TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

University Hospital, Gentofte, Copenhagen

Status: Unknown

Conditions: Psoriasis

Treatments: Drug: subjects will receive either infliximab, adalimumab or etanercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01657513

H-2-2012-001 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

tnf-alfa treatment (infliximab, adalimumab, or etanercept)

Experimental group

Description:

This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug

Treatment:

Drug: subjects will receive either infliximab, adalimumab or etanercept