A Phase IV multicentre, randomised, double-blind, placebo controlled, trial to evaluate the safety and efficacy of Raptiva ® in the treatment of subjects with moderate to severe plaque psoriasis involving hands and/or feet, with or without pustules. - TRUST study: Raptiva ® in hands & foot psoriasis

Merck Serono International SA0 sites168 target enrollmentJanuary 28, 2008

DrugsRaptiva 100 mg/ml powder and solvent for solution for injection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Serono International SA
Enrollment: 168
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 28, 2008

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Serono International SA

Eligibility Criteria

Inclusion Criteria

•1\) Subject with chronic (disease history of at least 6 months from diagnosis) moderate to severe plaque psoriasis involving the hands and/or feet (PGA – H\&F ratings of 3 or 4\) at screening, who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA.
•2\) Stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
•3\) At least 18 years old.
•4\) For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. For men, during the participation, it is mandatory to practice birth control, as there are not existing data on the effect of Raptiva ® on spermatogenesis.
•5\) Discontinuation of any systemic psoriasis treatment at study entry. No washout period is required for these traditional systemic psoriasis agents prior to starting study treatment.
•6\) Discontinuation of all biological agents at least 3 months prior to first study injection.
•7\) Discontinuation of any investigational drug or treatment at least 3 months prior to study Day 1 or as per washout requirements from previous protocol.
•8\) Willingness and ability to comply with the protocol requirements for the duration of the study.
•9\) Written informed consent, given prior to any study\-related procedure not part of normal medical care, with the understanding that the subject may withdraw his/her consent at any time without prejudice to future medical care.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\) Hypersensitivity to efalizumab or to any of the excipients
•2\) Current use of any prohibited therapy (systemic or topical treatments for psoriasis,
•immunosuppressive drugs, any other experimental drug, etc)
•3\) Previous or current exposure to Raptiva®
•4\) History of or ongoing alcohol or drug abuse
•5\) History of or an ongoing opportunistic infection (e.g. systemic fungal infection, parasites) or any other serious infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject will be excluded.
•6\) Seropositivity for hepatitis B antigen, hepatitis C antibody, or human mmunodeficiency virus (HIV). Subjects will undergo testing during screening, and any subjects who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
•7\) History of active or latent tuberculosis within one year prior to screening (to be determined by assessment according to national and/or local recommendation).
•8\) Presence or history of malignancy, including lymphoproliferative disorders.
•9\) Pregnancy or breast\-feeding