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

This study has been terminated.
(During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.)
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00381810
First received: September 26, 2006
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Lupus Erythematosus, Systemic
Drug: Rituximab
Drug: Methylprednisolone
Drug: Acetaminophen
Drug: Diphenhydramine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With at Least 1 Serious Adverse Event [ Time Frame: Baseline to the end of the study (up to 52 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: June 2006
Study Completion Date: February 2012
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab 1000 mg
Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Drug: Rituximab
Rituximab will be supplied as a liquid for intravenous infusion.
Drug: Methylprednisolone Drug: Acetaminophen Drug: Diphenhydramine

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381810

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Paul Brunetta, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00381810     History of Changes
Other Study ID Numbers: U3389g
Study First Received: September 26, 2006
Results First Received: November 11, 2009
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Rituxan
SLE
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Acetaminophen
Diphenhydramine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Promethazine
Rituximab
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Allergic Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipruritics
Antipyretics
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 26, 2015