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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g

Primary Purpose

Lupus Nephritis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus, U2970g

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
  • Participation in Study U2970g and completion of the Week 52 visit in that study
  • For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation

Exclusion Criteria:

  • Discontinuation or withdrawal from Study U2970g or failure to complete the Week 52 visit
  • Any safety concern potentially attributable to rituximab that in the investigator's opinion may jeopardize subject safety
  • In the investigator's opinion, lack of any clinical improvement by Week 52 in Study U2970g and for whom the proposed therapy would represent risk without benefit
  • Current thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
  • Lack of peripheral venous access
  • Pregnancy or lactation
  • History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant new or uncontrolled disease in any organ system not related to SLE (e.g., poorly controlled chronic obstructive pulmonary disease or asthma, cardiovascular disease, accelerated hypertension, major depression) that in the investigator's opinion would preclude subject participation
  • Known active infection of any kind (excluding fungal infection of nail beds), any major episode of infection requiring hospitalization, or treatment with IV antibiotics within 4 weeks of a study drug infusion or oral antibiotics within 2 weeks of a study drug infusion
  • History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ
  • Major surgery within 4 weeks prior to screening
  • Intolerance or contraindication to oral or IV corticosteroids
  • Lipase > 2 x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x the ULN
  • Amylase levels > 2 x the ULN
  • Absolute neutrophil counts < 1.5 x 10^3/uL
  • History of positive hepatitis B surface antigen or hepatitis C serology
  • Hemoglobin < 7 g/dL unless caused by autoimmune hemolytic anemia resulting from SLE
  • Platelet count < 10,000/uL
  • Receipt of a live vaccine within 28 days prior to treatment

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.

    Secondary Outcome Measures

    Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
    Serum rituximab levels
    Circulating B-cell counts.

    Full Information

    First Posted
    November 22, 2006
    Last Updated
    April 10, 2017
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00404157
    Brief Title
    A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
    Official Title
    A Phase III, Extension Study to Evaluate the Safety of Rituximab Retreatment in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis Previously Enrolled in Study U2970g
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lupus Nephritis
    Keywords
    Lupus, U2970g

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Rituximab
    Primary Outcome Measure Information:
    Title
    Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
    Title
    Serum rituximab levels
    Title
    Circulating B-cell counts.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability and willingness to provide written informed consent and comply with the requirements of the study protocol Participation in Study U2970g and completion of the Week 52 visit in that study For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation Exclusion Criteria: Discontinuation or withdrawal from Study U2970g or failure to complete the Week 52 visit Any safety concern potentially attributable to rituximab that in the investigator's opinion may jeopardize subject safety In the investigator's opinion, lack of any clinical improvement by Week 52 in Study U2970g and for whom the proposed therapy would represent risk without benefit Current thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions Lack of peripheral venous access Pregnancy or lactation History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies Significant new or uncontrolled disease in any organ system not related to SLE (e.g., poorly controlled chronic obstructive pulmonary disease or asthma, cardiovascular disease, accelerated hypertension, major depression) that in the investigator's opinion would preclude subject participation Known active infection of any kind (excluding fungal infection of nail beds), any major episode of infection requiring hospitalization, or treatment with IV antibiotics within 4 weeks of a study drug infusion or oral antibiotics within 2 weeks of a study drug infusion History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ Major surgery within 4 weeks prior to screening Intolerance or contraindication to oral or IV corticosteroids Lipase > 2 x the upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x the ULN Amylase levels > 2 x the ULN Absolute neutrophil counts < 1.5 x 10^3/uL History of positive hepatitis B surface antigen or hepatitis C serology Hemoglobin < 7 g/dL unless caused by autoimmune hemolytic anemia resulting from SLE Platelet count < 10,000/uL Receipt of a live vaccine within 28 days prior to treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jay Garg, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g

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