- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404157
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
April 10, 2017 updated by: Genentech, Inc.
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
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.
|
Secondary Outcome Measures
Outcome Measure |
---|
Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
|
Serum rituximab levels
|
Circulating B-cell counts.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jay Garg, M.D., Genentech, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 22, 2006
First Submitted That Met QC Criteria
November 22, 2006
First Posted (Estimate)
November 27, 2006
Study Record Updates
Last Update Posted (Actual)
April 12, 2017
Last Update Submitted That Met QC Criteria
April 10, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- U3388g
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lupus Nephritis
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Imperial College LondonKarolinska Institutet; Ohio State University; Dutch Working Party on Systemic... and other collaboratorsTerminatedSystemic Lupus Erythematosus, Lupus NephritisUnited Kingdom
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University Hospital, GrenobleInstitut de Biologie Structurale GrenobleCompletedSystemic Lupus Erythematosus NephritisFrance
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Sun Yat-sen UniversityCompleted
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Peking UniversityCompleted
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Minia UniversityNot yet recruitingmfERG in Lupus NephritisEgypt
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Centre Hospitalier Universitaire, AmiensCompletedLupus Nephritis | Systemic Lupus Erythematosus (SLE)France
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