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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
Results First Received: June 29, 2010  
Study Type: Interventional
Study Design: 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 
Overall Participants Analyzed 
[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 
[1] Numbers of participants with sPGA ratings of clear; minimal; mild; moderate; severe; or very severe
Biochemistry - C-Reactive Protein (CRP) [1] 
[Units: Participants]
 
Participants with <3 mg/L   36 
Participants with 3 mg/L-6mg/L   19 
Participants with >6 mg/L   15 
[1] Numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L
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 [1] 
[Units: Participants]
 
Negative   66 
Present   4 
[1] Number of participants with or without glucose detected in urine
Urinalysis - Ketones [1] 
[Units: Participants]
 
Negative   67 
Present   3 
[1] Number of participants with or without ketones detected in urine
Urinalysis - Values - Nitrite [1] 
[Units: Participants]
 
Negative   69 
Positive   1 
[1] Number of participants with or without nitrite detected in urine
Urinalysis - Leukocytes Esterase [1] 
[Units: Participants]
 
Negative   60 
Present   10 
[1] Number of participants with or without leukocytes esterase detected in urine
Urinalysis - Values - Protein 
[Units: Participants]
 
Negative   59 
Present   11 
Urinalysis - Blood [1] 
[Units: Participants]
 
Negative   66 
Present   4 
[1] Number of participants with or without blood detected in urine
Urinalysis - pH 
[Units: pH units]
Mean (Standard Deviation)
 5.84  (0.49) 


  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 reported.   Anticipated Reporting Date:   No text entered.  


  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



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