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Anti-CD20 in Systemic Lupus Erythematosus

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. Identifier: NCT00036491
Recruitment Status : Completed
First Posted : May 13, 2002
Last Update Posted : November 6, 2017
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE May 10, 2002
First Posted Date  ICMJE May 13, 2002
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE January 2001
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • Serum Autoantibodies [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56 ]
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • C3 and C4 complement levels
  • Systemic Lupus Activity Measure (SLAM) [ Time Frame: Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55 ]
  • Erythrocyte Sedimentation Rate (ESR)
  • Prednisone Dose [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56 ]
  • Renal Function
    Measured by creatinine clearance and total protein.
  • Modified Health Assessment Questionnaire (HAQ)
  • Short Form-36 Health Survey (SF-36)
  • Physician Global Assessment (VAS)
  • Patient Global Assessment (VAS)
  • Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index for SLE
  • Adverse Events
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 Anti-CD20 in Systemic Lupus Erythematosus
Official Title  ICMJE An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus
Brief Summary

The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE).

White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.

Detailed Description

B cells clearly play an essential role in the pathogenesis of SLE since they produce autoantibodies. Clinical observations support the contention that intervening in the production of autoantibodies by the B lymphocyte will be effective therapy. Current approved therapy for B-cell non-Hodgkin's lymphoma includes anti-CD20. The results of anti-CD20 administration in SLE are anticipated to be similar to those in lymphoma patients. The current proposal explores the mechanisms and applicability of B-cell depletion as a potential treatment for SLE.

Participants receive 4 weekly infusions of study medication. Each participant is enrolled in the study for a total of 1 year with protocol visits weekly for the first 3 months, then every other week for the next 2 months, every month for the next 4 months, and every other month for the remaining 5 months of the study (Weeks 0, 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 19, 23, 27, 31, 39, 47, and 55). Responses to exogenous antigens are measured; assessments for clinical response with SLE-disease activity score (SLEDEI) and systemic lupus activity measure (SLAM) score are performed. Participants complete a health questionnaire and a health survey and laboratory parameters are evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
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
Subjects received four weekly infusions of rituximab at a dose of 375 mg/m^2
Other Name: Rituxan®
Study Arms  ICMJE Experimental: rituximab
375 mg/m^2 administered intravenously
Intervention: Drug: Rituximab
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

People may be eligible for this study if they:

  • Are 18 to 70 years of age
  • Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends
  • Have SLE (by the American College of Rheumatology criteria)
  • Have had SLE for at least 6 months prior to screening
  • Have active SLE disease at the screening visit
  • Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart)
  • Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment
  • Meet blood, liver, and kidney laboratory values set by the protocol
  • Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment
  • Have been on a stable dose of oral corticosteroids, if taking them, for 4 weeks before the first week's visit. Oral corticosteroids may be altered as medically necessary after enrollment.
  • Have at least 1 elevated autoantibody level at screening visit.

Exclusion Criteria

People will not be eligible for this study if they:

  • Are pregnant or breast-feeding
  • Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial
  • Have cranial neuropathy (a condition affecting the head region)
  • Are on blood-thinning agents to prevent blood clotting
  • Have a serious skin disease
  • Have a certain class of heart disease
  • Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia
  • Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit
  • Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy)
  • Have received any experimental drug within 30 days of baseline visit
  • Have received any monoclonal antibody or similar medication within 3 months of the baseline visit
  • Received any intravenous, joint, or muscle injection of corticosteroids within 4 weeks of the baseline visit
  • Abuse alcohol or drugs
  • Are unwilling or unable to follow the protocol
  • Have poor veins for receiving injections.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 NCT00036491
Other Study ID Numbers  ICMJE DAIT AC002
SACCC #ASL02 ( Other Identifier: Statistical and Clinical Coordinating Center )
UPenn #U1131s ( Other Identifier: University of Pennsylvania )
ACE Study #AC002 ( Other Identifier: Autoimmunity Centers of Excellence )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Autoimmunity Centers of Excellence
Investigators  ICMJE
Study Chair: Robert A. Eisenberg, MD University of Pennsylvania
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date November 2017

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