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A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Raptiva (efalizumab)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Moderate to severe plaque psoriasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Previous participation in Study ACD2600g For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study Exclusion Criteria: Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to Efalizumab

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2004
    Last Updated
    March 19, 2014
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00096603
    Brief Title
    A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g
    Official Title
    An Open Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open label, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque psoriasis who previously participated in Study ACD2600g.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Moderate to severe plaque psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    None (Open Label)
    Enrollment
    450 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Raptiva (efalizumab)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Previous participation in Study ACD2600g For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study Exclusion Criteria: Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to Efalizumab

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

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