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

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ClinicalTrials.gov Identifier: NCT00109252
Recruitment Status : Completed
First Posted : April 26, 2005
Last Update Posted : June 21, 2013
Sponsor:
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
Criteria

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.
ClinicalTrials.gov 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
Topical

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases