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

Phase 1

• Conditions: 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.; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2007-004227-37-FR
• Lead Sponsor: Merck Serono International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-11
• Study Completion: 2009-03-03
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
10) History of hepatic cirrhosis, regardless of cause or severity
11) History of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a WBC count <4,000 cells/µL or >14,000 cells/µL, a haematocrit (HCT) <30% or a haemoglobin (Hgb) level <11 g/dL, a platelet count <150,000 cells/µL
12) Hepatic enzyme levels Q3 times the upper limit of normal or serum creatinine level Q2 times the upper limit of normal
13) Vaccination with a live or live-attenuated virus or live or live-attenuated bacteria vaccine within the 14 days prior to the first dose of Raptiva®
14) Any medical condition that, in the judgment of the Investigator, would jeopardise the subject’s safety following exposure to investigational medicinal product (Raptiva® or placebo equivalent) or would significantly interfere with the Subject’s ability to comply with the provisions of this protocol.
15) Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant for of psoriasis.
16) Immunodeficiencies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy of Raptiva ® against placebo to control chronic moderate to severe plaque-type psoriasis involving hands and/or feet scoring PGA (PGA - H&F) =3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and PUVA.;Secondary Objective: To evaluate the evolution of psoriasis events (rebound or exacerbation), during Raptiva ® therapy or after its discontinuation for any cause.<br>Exacerbation: continuous and slow disease worsening either during or after treatment, and occurring either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease, compared to baseline.<br><br>;Primary end point(s): Proportion of subjects achieving at week 12 a static Physician Global Assessment with Hand and Foot (PGA – H&F) rating of clear, almost clear, or mild, in subjects randomised to Raptiva ® as compared to placebo.