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ChangE From Any Systemic psoriasiS therapY to Raptiva (EASY)

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:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00697593
First received: June 11, 2008
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Hematology - Hematocrit [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Hemoglobin [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Red Blood Cell Count [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - White Blood Cell Count [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Neutrophils [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Eosinophils [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Basophils [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Monocytes [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Lymphocytes [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Hematology - Platelet Count [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Sodium [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Potassium [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Creatinine [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Total Bilirubin [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Aspartate Transaminase (AST) [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Alanine Transaminase (ALT) [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Alkaline Phosphatase [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Glutamyl Transferase [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - Urea [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Blood samples were taken for clinical laboratory testing

  • Biochemistry - C-Reactive Protein (CRP) [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    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

  • Urinalysis - pH [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing

  • Urinalysis - Protein [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine

  • Urinalysis - Ketones [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine

  • Urinalysis - Glucose [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine

  • Urinalysis - Blood [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine

  • Urinalysis - Nitrite [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine

  • Urinalysis - Leukocytes Esterase [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine

  • Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis [ Time Frame: Week 12 / Early Termination ] [ Designated as safety issue: Yes ]
    Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above


Secondary Outcome Measures:
  • Static Physician's Global Assessment (sPGA) [ Time Frame: 12 Weeks/Early Termination ] [ Designated as safety issue: No ]
    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).


Enrollment: 70
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00697593

Locations
Canada, Ontario
Probity Medical Research
City Waterloo, Ontario, Canada, N2J 1C4
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Nicole Selenko-Gebauer Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Maria Koutsopoulou, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00697593     History of Changes
Other Study ID Numbers: 27809
Study First Received: June 11, 2008
Results First Received: June 29, 2010
Last Updated: January 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Merck KGaA:
Efalizumab
Chronic Plaque Psoriasis
Transition from systemic therapies on to Efalizumab

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 19, 2014