TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

Psoriasis Clinical Trial

Official title:

Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01657513
• Other study ID #: H-2-2012-001
• Secondary ID: H-2-2012-001
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2012
• Last updated: August 3, 2012
• Start date: June 2012

Study information

• Verified date: August 2012
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Lone Skov, MD, PhD
• Phone: +4539773204
• Email: lone.skov.02[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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 - infliximab or adalimumab or etanercept The consulting dermatologist decides which drug to use according to official guidelines

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Gentofte, Department of Skin and Allergies	Hellerup
Sweden	Karolinska Institute, Department of Medicine	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Pfizer, The Michaelsen Foundation

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assessment of change in concentrations of other biomarkers of interest in psoriasis	Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest	3, 6, and 12 months after start of tnf-alfa blocking agent	No
Primary	change in concentration of tnf-alfa antibodies in serum	Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies	3, 6, and 12 months after start of tnf-alfa blocking agent	No
Secondary	change in severity of psoriasis, PASI	severity of psoriasis assessed by PASI	3, 6, and 12 months after start of tnf-alfa blocking agent	No
Secondary	Presence of psoriatic arthritis	Does the patient have psoriasis arthritis	3, 6, and 12 months after start of tnf-alfa blocking agent	No
Secondary	change in dermatology life quality index (DLQI)	psoriasis severity assessed by the dermatology life quality index (DLQI)	3, 6, and 12 months after start of tnf-alfa blocking agent	No
Secondary	height (cm)	subject´s height in centimeters	3 months	No
Secondary	change in weight (kg)	subjects weight in kilograms	3, 6, and 12 months after start of tnf-alfa blocking agent	No