Anti-CD20 in Systemic Lupus Erythematosus

November 1, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado
    • New York
      • Rochester, New York, United States, 14623
        • University of Rochester
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rituximab
375 mg/m^2 administered intravenously
Drug: Rituximab
Subjects received four weekly infusions of rituximab at a dose of 375 mg/m^2
Other Names:
  • Rituxan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Autoantibodies
Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56
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
Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Autoimmunity Centers of Excellence

Investigators

  • Study Chair: Robert A. Eisenberg, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 10, 2002

First Submitted That Met QC Criteria

May 10, 2002

First Posted (Estimate)

May 13, 2002

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY625
    Information comments: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
  2. Study Protocol
    Information identifier: SDY625
    Information comments: ImmPort study identifier is SDY625.
  3. Study summary, -design, -adverse event(s), -summary of participant assessments, -interventions, -medications, -demographics, -lab tests, -study files, et al.
    Information identifier: SDY625
    Information comments: ImmPort study identifier is SDY625.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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