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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00137969
• Date of registration: 26/08/2005
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus EXPLORER
• Scientific 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
• Date of first enrolment: May 10, 2005
• Target sample size: 262
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00137969
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Paul Brunetta, M.D.
• Affiliation: Genentech, Inc.

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Rituximab

Drug: Acetaminophen

Drug: Diphenhydramine

Drug: Prednisone

Drug: Placebo

Primary Outcome(s)

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 [Time Frame: From baseline to 52 weeks]

Secondary Outcome(s)

Number of Participants Who Achieved an MCR (Excluding PCR) [Time Frame: From baseline to 52 weeks]

Change in SLE Expanded Health Survey Physical Function Score From Baseline [Time Frame: From baseline to 52 weeks]

Number of Participants Who Achieved a BILAG C or Better in All Domains [Time Frame: 24 weeks]

Number of Participants Who Achieved an MCR in The ITT Population [Time Frame: From Weeks 24 to 52]

Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period [Time Frame: From baseline to 52 weeks]

Number of Participants Who Achieved a PCR (Including MCR) [Time Frame: From baseline to 52 Weeks]

Time to First Moderate or Severe Flare [Time Frame: 52 weeks]

Secondary ID(s)

U2971g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/12/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00137969