A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lupus Erythematosus, Systemic
Intervention: Rituximab (Drug); Placebo (Drug); Prednisone (Drug); Acetaminophen (Drug); Diphenhydramine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Genentech, Inc. Official(s) and/or principal investigator(s): Paul Brunetta, M.D., Study Director, Affiliation: Genentech, Inc.
Summary
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to
evaluate the efficacy and safety of rituximab compared with placebo when combined with a
single stable background immunosuppressive medication in subjects with moderate to severe
systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be
evaluated at 52 weeks.
Clinical Details
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
Secondary outcome: Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment PeriodNumber of Participants Who Achieved an MCR (Excluding PCR) Number of Participants Who Achieved a PCR (Including MCR) Number of Participants Who Achieved a BILAG C or Better in All Domains Time to First Moderate or Severe Flare Change in SLE Expanded Health Survey Physical Function Score From Baseline Number of Participants Who Achieved an MCR in The ITT Population
Eligibility
Minimum age: 16 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus (SLE).
- Active disease at screening.
- Stable use of one immunosuppressive drug.
- Use of an antimalarial drug.
- For subjects of reproductive potential (males and females), use of a reliable means
of contraception throughout their study participation.
Exclusion Criteria:
- Unstable patients 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.
- Active moderate to severe glomerulonephritis.
- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis,
stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active
and resulting from SLE.
- Lack of peripheral venous access.
- Pregnant women or nursing (breast feeding) mothers.
- History of severe, allergic, or anaphylactic reactions to humanized or murine
monoclonal antibodies.
- Significant, uncontrolled medical disease in any organ system not related to SLE that
in the investigator's opinion would preclude subject participation.
- Concomitant conditions that require oral or systemic corticosteroid use.
- Known human immunodeficiency virus (HIV) infection.
- 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.
- History of deep space infection.
- History of serious recurrent or chronic infection.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma
in situ.
- Active alcohol or drug abuse, or history of alcohol or drug abuse.
- Major surgery.
- Previous treatment with CAMPATH-1H antibody.
- Previous treatment with any B cell-targeted therapy.
- Treatment with any investigational agent within 28 days of screening (Day -7) or 5
half-lives of the investigational drug (whichever is longer).
- Receipt of a live vaccine within 28 days prior to screening.
- Intolerance or contraindication to oral or IV corticosteroids.
- Use of a new immunosuppressive drug prior to screening or change in dose of ongoing
immunosuppressive drug prior to screening.
- Prednisone dose of ≥ 1 mg/kg/day prior to screening.
- Treatment with cyclophosphamide or a calcineurin inhibitor.
- Treatment with a second immunosuppressive or immunomodulatory drug.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2. 5 x the upper
limit of normal.
Locations and Contacts
Additional Information
Starting date: May 2005
Last updated: April 30, 2015
|