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A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00287118
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Candidates for Systemic Therapy for Psoriasis
Psoriasis
Intervention: Drug: Efalizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Efalizumab Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.

Participant Flow:   Overall Study
    Efalizumab
STARTED   189 
COMPLETED   137 
NOT COMPLETED   52 
Adverse Event                30 
Death                1 
Lack of Efficacy                11 
Lost to Follow-up                1 
Protocol Violation                2 
Not specified                7 



  Baseline Characteristics

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 Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.

Baseline Measures
   Efalizumab 
Overall Participants Analyzed 
[Units: Participants]
 189 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (12.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      55  29.1% 
Male      134  70.9% 


  Outcome Measures

1.  Primary:   Percentage of Subjects With Physician’s Global Assessment (PGA) Ratings of “Excellent” or “Cleared” at Week 24   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 Healthcare, a business of Merck KGaA, Darmstadt, Germany
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


Publications of Results:

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00287118     History of Changes
Other Study ID Numbers: 25161
CONTROL I Study
First Submitted: February 2, 2006
First Posted: February 6, 2006
Results First Submitted: August 29, 2017
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018