ChangE From Any Systemic psoriasiS therapY to Raptiva (EASY)

A Phase IV Open Label Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Transitioning From Previous Systemic Antipsoriasis Therapies (Methotrexate, Cyclosporine, Retinoids or Psoralen-Ultraviolet Light A (PUVA), Narrow-Band Ultraviolet Light B (NBUVB) to Raptiva 1mg/kg/ Week Therapy.

To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.

Study Overview

• Status: Terminated
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • City Waterloo, Ontario, Canada, N2J 1C4
      • Probity Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are at least 18 years old.
2. Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment.
3. Are transitioning from methotrexate, cyclosporine, retinoids, PUVA or NBUVB and initiating treatment with Raptiva according to the decision of the investigator and in accordance with the indication and the recommendations of the Raptiva Investigator Brochure, i.e. to which they have failed to respond, have a contraindication to or are intolerant of other systemic therapies.
4. Agree to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
5. Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
6. Women of childbearing potential must use appropriate contraception during treatment and up to the last study visit (safety follow-up visit). For men, it is also mandatory to practice contraception during participation in the trial, as there are no existing data on the effect of Raptiva on spermatogenesis.
7. Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol.

No primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."

Exclusion Criteria:

1. Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:

   • Hypersensitivity to Raptiva or to any of the excipients.
   • Subjects with history of malignancies.
   • History of active tuberculosis (TB) or currently undergoing treatment for TB. Purified Protein Derivative (PPD) testing or chest X-ray is required for high-risk subjects. Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded.
   • Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
   • Subjects with immunodeficiencies.
2. Simultaneous participation in another clinical trial.
3. Subjects experiencing a psoriasis exacerbation during screening period.
4. Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the subject can be included in this study.
5. History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
6. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.
7. Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level =/>2 times the upper limit of normal.
8. Pregnant or breast-feeding.
9. Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject's safety following exposure to study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efalizumab	Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb); Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematology - Hematocrit	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Hemoglobin	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Red Blood Cell Count	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - White Blood Cell Count	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Neutrophils	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Eosinophils	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Basophils	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Monocytes	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Lymphocytes	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Hematology - Platelet Count	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Sodium	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Potassium	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Creatinine	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Total Bilirubin	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Aspartate Transaminase (AST)	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Alanine Transaminase (ALT)	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Alkaline Phosphatase	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Glutamyl Transferase	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - Urea	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination
Biochemistry - C-Reactive Protein (CRP)	Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L	Week 12 / Early Termination
Urinalysis - pH	Urine samples were taken for clinical laboratory testing	Week 12 / Early Termination
Urinalysis - Protein	Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine	Week 12 / Early Termination
Urinalysis - Ketones	Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine	Week 12 / Early Termination
Urinalysis - Glucose	Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine	Week 12 / Early Termination
Urinalysis - Blood	Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine	Week 12 / Early Termination
Urinalysis - Nitrite	Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine	Week 12 / Early Termination
Urinalysis - Leukocytes Esterase	Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine	Week 12 / Early Termination
Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis	Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above	Week 12 / Early Termination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Physician's Global Assessment (sPGA)	Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).	12 Weeks/Early Termination

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Nicole Selenko-Gebauer, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Plaque Psoriasis; Efalizumab; Transition from systemic therapies on to Efalizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: 27809