Back to resultsA 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Withdrawn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
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus, U2970g
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
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
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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