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

Lupus Erythematosus, Systemic Clinical Trial

— VOYAGER  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00381810
• Other study ID #: U3389g
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 26, 2006
• Last updated: March 24, 2015
• Start date: June 2006
• Est. completion date: February 2012

Study information

• Verified date: March 2015
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 2012
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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• Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Rituximab
Rituximab will be supplied as a liquid for intravenous infusion.
• Methylprednisolone

• Acetaminophen

• Diphenhydramine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least 1 Serious Adverse Event	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.	Baseline to the end of the study (up to 52 weeks)	No