Lupus Erythematosus, Systemic
Conditions
Keywords
Rituxan, SLE, Lupus
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.
Interventions
DRUGRituximab
Rituximab will be supplied as a liquid for intravenous infusion.
DRUGMethylprednisolone
DRUGAcetaminophen
DRUGDiphenhydramine
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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* Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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 * Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Serious Adverse Event | Baseline to the end of the study (up to 52 weeks) | A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab 1000 mg Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Rituximab 1000 mg |
|---|---|
| Age, Continuous | 44.0 years STANDARD_DEVIATION 12.3 |
| Age, Customized 20-64 years | 31 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 31 |
| serious Total, serious adverse events | 11 / 31 |
Outcome results
Primary
Percentage of Participants With at Least 1 Serious Adverse Event
A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
Time frame: Baseline to the end of the study (up to 52 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab 1000 mg | Percentage of Participants With at Least 1 Serious Adverse Event | 35.5 Percentage of participants |