A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Patients With Moderate to Severe Plaque Psoriasis
This study has been completed.
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First received: February 2, 2006
Last updated: March 21, 2009
Last verified: March 2009
Phase IIIb, open-label, multi-centre study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered SC for 24 weeks.
Candidates for Systemic Therapy for Psoriasis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- Proportion of patients achieving or maintaining a PGA (Physician Global Assessment) 7 points score, rated Excellent, or Cleared at week 24. [ Time Frame: PGA, PASI, DLQI, PSSI, PPASI to be collected at baseline, weeks 4, 8, 12, and 24 or early termination ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Each patient will receive an initial conditioning dose of 0.7 mg/kg/week followed by 1.0 mg/kg/week study drug during the treatment period, 23 weeks. If four or more consecutive doses have been missed, dosing should resume with the conditioning dose of 0.7 mg/kg and then continue receiving 1mg/kg/week thereafter. Study drug will be administered by SC injection.
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