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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

June 11, 2008
January 20, 2014
January 2008
April 2009   (final data collection date for primary outcome measure)
  • 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
The primary endpoint is safety, and will include all AEs, SAEs, and laboratory data (haematology and biochemistry) and urinalysis at all time points, divided by tapering and previous treatment. [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00697593 on ClinicalTrials.gov Archive Site
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).
The secondary endpoint will be the efficacy of Raptiva after 12 weeks therapy, measured as the proportion of subjects who achieve an sPGA assessment of minimal or clear at Week 12 (Day 85). [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
ChangE From Any Systemic psoriasiS therapY to Raptiva
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Plaque Psoriasis
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.
Experimental: Efalizumab
Intervention: Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00697593
27809
Not Provided
Maria Koutsopoulou, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA
Not Provided
Study Director: Nicole Selenko-Gebauer Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP