Overview

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Status:
Completed
Trial end date:
2008-08-25
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Acetaminophen
Diphenhydramine
Prednisone
Promethazine
Rituximab
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.