TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

Not Applicable

• Conditions: Psoriasis
• Interventions: Drug: subjects will receive either infliximab, adalimumab or etanercept

• Registration Number: NCT01657513
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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 available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-30
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-03
• Last Update Submitted: 2012-08-03
• Study First Posted: 2012-08-06
• Last Update Posted: 2012-08-06
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tnf-alfa treatment (infliximab, adalimumab, or etanercept)	subjects will receive either 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 Measures

Name	Time	Method
change in concentration of tnf-alfa antibodies in serum	3, 6, and 12 months after start of tnf-alfa blocking agent	Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies

Secondary Outcome Measures

Name	Time	Method
change in weight (kg)	3, 6, and 12 months after start of tnf-alfa blocking agent	subjects weight in kilograms
height (cm)	3 months	subject´s height in centimeters
change in dermatology life quality index (DLQI)	3, 6, and 12 months after start of tnf-alfa blocking agent	psoriasis severity assessed by the dermatology life quality index (DLQI)
change in severity of psoriasis, PASI	3, 6, and 12 months after start of tnf-alfa blocking agent	severity of psoriasis assessed by PASI
Presence of psoriatic arthritis	3, 6, and 12 months after start of tnf-alfa blocking agent	Does the patient have psoriasis arthritis

Trial Locations

Locations (2)

Karolinska Institute, Department of Medicine; 🇸🇪 Stockholm, Sweden

Copenhagen University Hospital Gentofte, Department of Skin and Allergies; 🇩🇰 Hellerup, Denmark