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A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Diagnosis of plaque psoriasis for >=6 months A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening Plaque psoriasis covering >=10% of total Body Surface Area (BSA) In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or who has received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil [MMF], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept) 18 to 70 years old Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis Clinically significant psoriasis flare during the 3 months prior to enrollment Pregnancy or lactation History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection History of opportunistic infections (e.g., systemic fungal infections, parasites) Seropositivity for hepatitis B or C virus Seropositivity for human immunodeficiency virus (HIV) History of active tuberculosis (TB) or currently undergoing treatment for TB Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders Diagnosis of hepatic cirrhosis, regardless of cause or severity Hospital admission for cardiovascular or pulmonary disease within the last year History of substance abuse within the last 5 years History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an immunoglobulin (Ig) Fc region (e.g., etanercept, LFA3TIP) History of severe allergic reactions to or intolerance of topical corticosteroid therapies Previous treatment with efalizumab History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, LFA3TIP) WBC count <4000/uL or >14,000/uL Hepatic enzymes >=3 times the upper limit of normal Creatinine >=2 times the upper limit of normal Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug Any medical or other condition that, in the judgment of the investigator, would significantly interfere with the subject's ability to comply with the provisions of this protocol Topical therapy for psoriasis Systemic therapy for psoriasis Systemic immunosuppressive drugs Tanning beds, booths, or home UV light sources Live virus or bacteria vaccine Other vaccines or allergy desensitization injections Other experimental drugs or treatments Nonsteroidal anti inflammatory drugs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2004
    Last Updated
    June 19, 2013
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00096980
    Brief Title
    A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies
    Official Title
    An Open Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneously Administered Efalizumab Used in Combination With Topical Psoriasis Therapies for Prolonged Maintenance Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 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 study is an open label, randomized, multicenter study designed to compare the efficacy of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects who derive benefit from the initial 12 weeks of treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (false)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Diagnosis of plaque psoriasis for >=6 months A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening Plaque psoriasis covering >=10% of total Body Surface Area (BSA) In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or who has received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil [MMF], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept) 18 to 70 years old Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis Clinically significant psoriasis flare during the 3 months prior to enrollment Pregnancy or lactation History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection History of opportunistic infections (e.g., systemic fungal infections, parasites) Seropositivity for hepatitis B or C virus Seropositivity for human immunodeficiency virus (HIV) History of active tuberculosis (TB) or currently undergoing treatment for TB Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders Diagnosis of hepatic cirrhosis, regardless of cause or severity Hospital admission for cardiovascular or pulmonary disease within the last year History of substance abuse within the last 5 years History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an immunoglobulin (Ig) Fc region (e.g., etanercept, LFA3TIP) History of severe allergic reactions to or intolerance of topical corticosteroid therapies Previous treatment with efalizumab History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, LFA3TIP) WBC count <4000/uL or >14,000/uL Hepatic enzymes >=3 times the upper limit of normal Creatinine >=2 times the upper limit of normal Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug Any medical or other condition that, in the judgment of the investigator, would significantly interfere with the subject's ability to comply with the provisions of this protocol Topical therapy for psoriasis Systemic therapy for psoriasis Systemic immunosuppressive drugs Tanning beds, booths, or home UV light sources Live virus or bacteria vaccine Other vaccines or allergy desensitization injections Other experimental drugs or treatments Nonsteroidal anti inflammatory drugs

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18856162
    Citation
    Lamerson C, Stevens G, Sax K. Treatment of nail psoriasis with efalizumab: a preliminary study. Cutis. 2008 Sep;82(3):217-20.
    Results Reference
    derived

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    A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies

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