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Trial record 2 of 13 for:    raptiva for chronic moderate to severe plaque psoriasis

TRUST Study: Raptiva ® in Hand & Foot Psoriasis

This study has been terminated.
(The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union)
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00739882
First received: August 20, 2008
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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


  • Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    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


  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    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


  • Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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


  • Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.

    Cleared = 100% improvement; Excellent = 75-99% improvement



Enrollment: 76
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Efalizumab 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 Comparator: Placebo Drug: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739882

Locations
Austria
University of Vienna Medical School
Vienna, Austria
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Nicole Selenko-Gebauer, MD Merck Serono S.A., Geneva
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00739882     History of Changes
Other Study ID Numbers: 27808
Study First Received: August 20, 2008
Results First Received: June 28, 2010
Last Updated: January 26, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Ethics Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck KGaA:
Efalizumab,
Chronic plaque psoriasis
moderate to severe
involving
hands
feet

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014