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

NCT00381810 | Terminated Phase 3 Results

• 1 other identifier: U3389g
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 11

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Rituxan; SLE; Lupus

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Rituximab 1000 mg

EXPERIMENTAL

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; Drug: Methylprednisolone; Drug: Acetaminophen; Drug: Diphenhydramine

Interventions

Rituximab DRUG

Rituximab will be supplied as a liquid for intravenous infusion.

Rituximab 1000 mg

Methylprednisolone DRUG

Rituximab 1000 mg

Acetaminophen DRUG

Rituximab 1000 mg

Diphenhydramine DRUG

Rituximab 1000 mg

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (11)

Arizona Arthritis & Rheumatology Research, Pllc

Paradise Valley, Arizona, 85253, United States

Location

Eden Medical Center San Leandro Hospital

San Leandro, California, 94578, United States

Location

Intermountain Research Center

Boise, Idaho, 83702, United States

Location

Coeur D'Alene Arthritis Clinic

Coeur d'Alene, Idaho, 83814, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology

Great Neck, New York, 11021, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Medical Univ of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Research Center

Sugar Land, Texas, 77479, United States

Location

Seattle Rheumatology Assoc; Swedish Rheumatology Research

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Rituximab; Methylprednisolone; Acetaminophen; Diphenhydramine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Since study U2971g did not demonstrate efficacy, a decision was made not to evaluate efficacy in this study and only safety results were evaluated.

Results Point of Contact

• Title: Medical Communications Specialist
• Organization: Genentech, Inc.

genentech@druginfo.com

800 821-8590

Study Officials

• Paul Brunetta, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: June 22, 2006
• Primary Completion: July 31, 2008
• Study Completion: February 29, 2012
• Last Updated: August 1, 2017
• Results First Posted: December 18, 2009

Record last verified: 2017-06

Locations

US (11)