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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381810
Recruitment Status : Terminated (During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.)
First Posted : September 28, 2006
Results First Posted : December 18, 2009
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE September 26, 2006
First Posted Date  ICMJE September 28, 2006
Results First Submitted Date  ICMJE November 11, 2009
Results First Posted Date  ICMJE December 18, 2009
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE June 22, 2006
Actual Primary Completion Date July 31, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
Percentage of Participants With at Least 1 Serious Adverse Event [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2006)
  • Proportion of subjects with a PCR at screening who improve their clinical response to an MCR at Week 52 after the first dose of study drug in Study U3389g
  • Proportion of subjects with an NCR who attain a PCR or an MCR at the end of the 12-month rituximab retreatment cycle
  • Time to first moderate or severe flare among PCR and MCR subjects from screening to Week 52 after the first dose of study drug in Study U3389g
  • Proportion of subjects with an MCR at screening who maintain an MCR from screening to Week 52 after the first dose of study drug in Study U3389g
  • Time-adjusted area under the curve minus baseline (AUCMB) of BILAG global score from screening to Week 52 after the first dose of study drug in Study U3389g
  • Change in SLE Expanded Health Survey physical component summary score from screening to Week 52 after the first dose of study drug in Study U3389g
  • Change in damage measured by SLICC/ACR from screening to Week 52 after the first dose of study drug in Study U3389g
  • Cumulative prednisone dosage as measured by area under the curve (AUC) of prednisone use from screening through Week 52 after the first dose of study drug in Study U3389g.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE
  • Drug: Rituximab
    Rituximab will be supplied as a liquid for intravenous infusion.
  • Drug: Methylprednisolone
  • Drug: Acetaminophen
  • Drug: Diphenhydramine
Study Arms  ICMJE 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.
Interventions:
  • Drug: Rituximab
  • Drug: Methylprednisolone
  • Drug: Acetaminophen
  • Drug: Diphenhydramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 12, 2009)
31
Original Enrollment  ICMJE
 (submitted: September 26, 2006)
250
Actual Study Completion Date  ICMJE February 29, 2012
Actual Primary Completion Date July 31, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00381810
Other Study ID Numbers  ICMJE U3389g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul Brunetta, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP