Clinical trial NCT00381810: A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Official title: An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Keywords: Rituxan
SLE
Lupus
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.


Eligibility criteria: Inclusion Criteria:

* Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
* For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.

Exclusion Criteria:

* Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
* Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
* Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
* Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
* Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
* Pregnant women or nursing (breastfeeding) mothers.
* History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening.
* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
* Major surgery within 4 weeks prior to screening.
* Intolerance or contraindication to oral or IV corticosteroids.
* Positive hepatitis B surface antigen (BsAg) or hepatitis C serology.
* Receipt of a live vaccine within 28 days prior to treatment.

Primary outcomes:
measure: Percentage of Participants With at Least 1 Serious Adverse Event
timeFrame: Baseline to the end of the study (up to 52 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Research, Pllc
state: Arizona
city: San Leandro
country: United States
facility: Eden Medical Center San Leandro Hospital
state: California
city: Boise
country: United States
facility: Intermountain Research Center
state: Idaho
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthritis Clinic
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Great Neck
country: United States
facility: North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Charleston
country: United States
facility: Medical Univ of South Carolina
state: South Carolina
city: Sugar Land
country: United States
facility: Texas Research Center
state: Texas
city: Seattle
country: United States
facility: Seattle Rheumatology Assoc; Swedish Rheumatology Research
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Paul Brunetta, M.D.
role: STUDY_DIRECTOR
References: