TRUST Study: Raptiva ® in Hand & Foot Psoriasis

Chronic Plaque Psoriasis Clinical Trial

— TRUST  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739882
• Other study ID #: 27808
• Status: Terminated
• Phase: Phase 4
• First received: August 20, 2008
• Last updated: January 26, 2014
• Start date: April 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutGreece: National Organization of MedicinesItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Ethics CommitteeTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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. Subjects will be outpatients.

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 SD 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.

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 immunodeficiency 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 white blood cell 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 =3 times the upper limit of normal or serum creatinine level =2 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Efalizumab - anti CD11a recombinant human monoclonal antibody
Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with = 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement = 50%) will be followed in an observational manner for 12 additional weeks without treatment.
• Placebo
Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)

Locations

Country	Name	City	State
Austria	University of Vienna Medical School	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12	The proportion of subjects achieving a PGA - H&F rating of clear, almost clear, or mild at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet	12 weeks	No
Secondary	Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12	The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet	12 weeks	No
Secondary	Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24	The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet	24 weeks	No
Secondary	Proportion of Participants From the Initial Placebo Group Achieving a PGA - H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.	The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 24: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet	24 weeks	No
Secondary	Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12	The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.; Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement	12 weeks	No
Secondary	Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12	The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.; Cleared = 100% improvement; Excellent = 75-99% improvement	12 weeks	No