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
Results First Received: June 29, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Plaque Psoriasis
Intervention: Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of first subject first visit: 22 January 2008 Date of last subject last visit: 21 April 2009 Subjects were enrolled at 13 study centers in 2 countries, including 10 study centers in Canada and 3 study centers in the Netherlands.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were to be screened for study eligibility within 14 days before Day 1

Reporting Groups
  Description
Efalizumab Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection

Participant Flow:   Overall Study
    Efalizumab  
STARTED     70  
COMPLETED     51  
NOT COMPLETED     19  
Adverse Event                 3  
Protocol Violation                 1  
Lack of Efficacy                 3  
Suspension of the study by sponsor                 12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Efalizumab Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection

Baseline Measures
    Efalizumab  
Number of Participants  
[units: participants]
  70  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 14.7  
Age, Customized  
[units: participants]
 
18 - 40 years     26  
41 to 64 years     36  
>64 years     8  
Gender  
[units: participants]
 
Female     25  
Male     45  
Region of Enrollment  
[units: participants]
 
Canada     60  
Netherlands     10  
static Physician's Global Assessment (sPGA) [1]
[units: participants]
 
Clear     0  
Minimal     4  
Mild     6  
Moderate     38  
Severe     21  
Very Severe     1  
Biochemistry - C-Reactive Protein (CRP) [2]
[units: participants]
 
Participants with <3 mg/L     36  
Participants with 3 mg/L-6mg/L     19  
Participants with >6 mg/L     15  
Biochemistry - Alanine Transaminase (ALT)  
[units: IU/L]
Mean ± Standard Deviation
  27.8  ± 12.2  
Biochemistry - Alkaline Phosphatase  
[units: IU/L]
Mean ± Standard Deviation
  76.6  ± 19.0  
Biochemistry - Aspartate Transaminase (AST)  
[units: IU/L]
Mean ± Standard Deviation
  23.0  ± 7.8  
Biochemistry - Creatinine  
[units: μmol/L]
Mean ± Standard Deviation
  82.9  ± 18.9  
Biochemistry - Glutamyl Transferase  
[units: IU/L]
Mean ± Standard Deviation
  25.9  ± 15.3  
Biochemistry - Potassium  
[units: mmol/L]
Mean ± Standard Deviation
  4.19  ± 0.36  
Biochemistry - Values: Sodium  
[units: mmol/L]
Mean ± Standard Deviation
  139.5  ± 1.9  
Biochemistry - Total Bilirubin  
[units: μmol/L]
Mean ± Standard Deviation
  8.0  ± 4.7  
Biochemistry - Urea  
[units: mmol/L]
Mean ± Standard Deviation
  5.677  ± 1.633  
Hematology - Hematocrit  
[units: packed cell volume]
Mean ± Standard Deviation
  0.430  ± 0.040  
Hematology - Hemoglobin  
[units: g/L]
Mean ± Standard Deviation
  145.0  ± 13.7  
Hematology - Red Blood Cell Count  
[units: x10^12/L]
Mean ± Standard Deviation
  4.69  ± 0.52  
Hematology - White Blood Cell Count  
[units: x10^9/L]
Mean ± Standard Deviation
  7.11  ± 1.95  
Hematology - Basophils  
[units: x10^9/L]
Mean ± Standard Deviation
  0.032  ± 0.033  
Hematology - Eosinophils  
[units: x10^9/L]
Mean ± Standard Deviation
  0.177  ± 0.135  
Hematology - Lymphocytes  
[units: x10^9/L]
Mean ± Standard Deviation
  1.911  ± 0.670  
Hematology - Monocytes  
[units: x10^9/L]
Mean ± Standard Deviation
  0.462  ± 0.188  
Hematology - Neutrophils  
[units: x10^9/L]
Mean ± Standard Deviation
  4.533  ± 1.582  
Hematology - Platelet Count  
[units: x10^9/L]
Mean ± Standard Deviation
  256.0  ± 54.7  
Urinalysis - Glucose [3]
[units: participants]
 
Negative     66  
Present     4  
Urinalysis - Ketones [4]
[units: participants]
 
Negative     67  
Present     3  
Urinalysis - Values - Nitrite [5]
[units: participants]
 
Negative     69  
Positive     1  
Urinalysis - Leukocytes Esterase [6]
[units: participants]
 
Negative     60  
Present     10  
Urinalysis - Values - Protein  
[units: participants]
 
Negative     59  
Present     11  
Urinalysis - Blood [7]
[units: participants]
 
Negative     66  
Present     4  
Urinalysis - pH  
[units: pH units]
Mean ± Standard Deviation
  5.84  ± 0.49  
[1] Numbers of participants with sPGA ratings of clear; minimal; mild; moderate; severe; or very severe
[2] Numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L
[3] Number of participants with or without glucose detected in urine
[4] Number of participants with or without ketones detected in urine
[5] Number of participants with or without nitrite detected in urine
[6] Number of participants with or without leukocytes esterase detected in urine
[7] Number of participants with or without blood detected in urine



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hematology - Hematocrit   [ Time Frame: Week 12 / Early Termination ]

2.  Primary:   Hematology - Hemoglobin   [ Time Frame: Week 12 / Early Termination ]

3.  Primary:   Hematology - Red Blood Cell Count   [ Time Frame: Week 12 / Early Termination ]

4.  Primary:   Hematology - White Blood Cell Count   [ Time Frame: Week 12 / Early Termination ]

5.  Primary:   Hematology - Neutrophils   [ Time Frame: Week 12 / Early Termination ]

6.  Primary:   Hematology - Eosinophils   [ Time Frame: Week 12 / Early Termination ]

7.  Primary:   Hematology - Basophils   [ Time Frame: Week 12 / Early Termination ]

8.  Primary:   Hematology - Monocytes   [ Time Frame: Week 12 / Early Termination ]

9.  Primary:   Hematology - Lymphocytes   [ Time Frame: Week 12 / Early Termination ]

10.  Primary:   Hematology - Platelet Count   [ Time Frame: Week 12 / Early Termination ]

11.  Primary:   Biochemistry - Sodium   [ Time Frame: Week 12 / Early Termination ]

12.  Primary:   Biochemistry - Potassium   [ Time Frame: Week 12 / Early Termination ]

13.  Primary:   Biochemistry - Creatinine   [ Time Frame: Week 12 / Early Termination ]

14.  Primary:   Biochemistry - Total Bilirubin   [ Time Frame: Week 12 / Early Termination ]

15.  Primary:   Biochemistry - Aspartate Transaminase (AST)   [ Time Frame: Week 12 / Early Termination ]

16.  Primary:   Biochemistry - Alanine Transaminase (ALT)   [ Time Frame: Week 12 / Early Termination ]

17.  Primary:   Biochemistry - Alkaline Phosphatase   [ Time Frame: Week 12 / Early Termination ]

18.  Primary:   Biochemistry - Glutamyl Transferase   [ Time Frame: Week 12 / Early Termination ]

19.  Primary:   Biochemistry - Urea   [ Time Frame: Week 12 / Early Termination ]

20.  Primary:   Biochemistry - C-Reactive Protein (CRP)   [ Time Frame: Week 12 / Early Termination ]

21.  Primary:   Urinalysis - pH   [ Time Frame: Week 12 / Early Termination ]

22.  Primary:   Urinalysis - Protein   [ Time Frame: Week 12 / Early Termination ]

23.  Primary:   Urinalysis - Ketones   [ Time Frame: Week 12 / Early Termination ]

24.  Primary:   Urinalysis - Glucose   [ Time Frame: Week 12 / Early Termination ]

25.  Primary:   Urinalysis - Blood   [ Time Frame: Week 12 / Early Termination ]

26.  Primary:   Urinalysis - Nitrite   [ Time Frame: Week 12 / Early Termination ]

27.  Primary:   Urinalysis - Leukocytes Esterase   [ Time Frame: Week 12 / Early Termination ]

28.  Secondary:   Static Physician’s Global Assessment (sPGA)   [ Time Frame: 12 Weeks/Early Termination ]

29.  Primary:   Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis   [ Time Frame: Week 12 / Early Termination ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono S.A., a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


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