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

Purpose

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.

Condition	Intervention	Phase
Lupus Nephritis	Drug: Rituximab	Phase 3


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Rituximab

Genetic and Rare Diseases Information Center resources: Lupus Nephritis Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

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.


Enrollment:	0

Eligibility


Ages Eligible for Study:	16 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404157

Sponsors and Collaborators

Genentech, Inc.

Investigators


Study Director:	Jay Garg, M.D.	Genentech, Inc.

More Information


Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00404157 History of Changes
Other Study ID Numbers:	U3388g
Study First Received:	November 22, 2006
Last Updated:	April 10, 2017

Keywords provided by Genentech, Inc.:


Lupus U2970g

Additional relevant MeSH terms:


Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases	Autoimmune Diseases Immune System Diseases Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

ClinicalTrials.gov processed this record on June 23, 2017