A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00109252
First received: April 26, 2005
Last updated: June 19, 2013
Last verified: June 2013

April 26, 2005
June 19, 2013
January 2002
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Complete list of historical versions of study NCT00109252 on ClinicalTrials.gov Archive Site
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A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.

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Interventional
Phase 3
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
Drug: Raptiva (efalizumab)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
April 2003
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Inclusion Criteria:

  • Signed informed consent
  • Previous participation in Study ACD2390g
  • For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study
  • Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study

Exclusion Criteria:

  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab
  • Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first)
  • Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84)
  • Topical therapies for psoriasis (ET Day 0 through ET Day 84)
  • Live virus or bacteria vaccines (ET Day 0 through FU Day 84)
  • Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84)
  • Other experimental drugs or treatments (ET Day 0 through FU Day 84)
  • Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00109252
ACD2391g
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Genentech
Genentech
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Genentech
June 2013

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