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

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. Identifier: NCT00109252
Recruitment Status : Completed
First Posted : April 26, 2005
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Raptiva (efalizumab) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2002
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Responsible Party: Genentech, Inc. Identifier: NCT00109252     History of Changes
Other Study ID Numbers: ACD2391g
First Posted: April 26, 2005    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Genentech, Inc.:
Plaque Psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases