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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00381810 |
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Date of registration:
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26/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
VOYAGER |
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Scientific title:
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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 |
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Date of first enrolment:
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June 22, 2006 |
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Target sample size:
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31 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00381810 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul Brunetta, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genentech, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Intervention(s)
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Drug: Diphenhydramine
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Drug: Methylprednisolone
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Drug: Rituximab
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Drug: Acetaminophen
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Primary Outcome(s)
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Percentage of Participants With at Least 1 Serious Adverse Event
[Time Frame: Baseline to the end of the study (up to 52 weeks)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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