Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE

October 4, 2012 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Rituximab in SLE: Understanding of Long-term Responses and the Impact of B Cell Depletion on T Cells

The purpose of this study is to determine how B cell subsets and autoantibodies are related to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus (SLE).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Immune cells are an important part of the abnormal autoimmune response in SLE. The B cell is a significant part of this autimmune response because it produces the antibodies which can react with normal tissue of the body. B cells have the ability to accumulate and promote the development of SLE. The purpose of this study is to determine how B cell subsets and autoantibodies are related to disease remission after rituximab treatment in subjects with SLE.

This study will last approximately two years and consist of 15 study visits. These visits will occur at screening, baseline, Days 0 and 14, and Months 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Participants will receive a single rituximab injection on Days 0 and 14. Medication history and blood tests will occur at every study visit. A physical exam, medical history, and urine tests will occur at most visits. For females, a pregnancy test will occur at selected visits.

Study Type

Interventional

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of SLE
  • Positive ANA with a titer of at least 1:160
  • Active disease (one or more modified BILAG A or B) or inability to lower steroids to leass than 20 mg/day. More information about this criterion can be found in the protocol.
  • For females, must agree to use effective birth control methods for the duration of the study

Exclusion Criteria:

  • Severe thrombocytopenia
  • Active, moderate, or severe proliferative glomerulonephritis
  • Active CNS manifestations due to lupus other than migraines, mild cognitive dysfunction, or mood disorders. More information about this criterion can be found in the protocol.
  • Poorly controlled anti-phospholipid syndrom
  • Significant organ dysfunction
  • Conditions, other than SLE, that are likely to require prolonged systemic steroids
  • Chronic infections. More information about this criterion can be found in the protocol.
  • Hepatitis B infection
  • Hepatitis C infection
  • Deep space infection within two years of study entry
  • Severe bacterial infection within three months of study entry
  • More than one severe bacterial infection within two years of study entry
  • Positive purified protein derivative tuberculin skin test
  • History of cancer, not including basal cell carcinomas and carcinoma in situ of the cervix with documentation of successful treatment
  • Alcohol or drug abuse
  • Surgery within three months of study entry
  • Immunization with a live vaccine within two months of study entry
  • Any immunization within one month of study entry
  • Received cyclophosphamide or calcineurin inhibitors within six months of study entry
  • Received anti-TNF alpha antibody within 3 months of study entry
  • Received etanercept within one month of study entry
  • Received anti-CD20 antibodies or other lymphocyte depleting antibodies
  • Received Immunoglobin G infusion protein or monoclonal antibody
  • Treatment with FDA non-approved agents within six months of study entry
  • Transaminases greater than two times the upper limit of normal
  • Pregnant or breastfeeding

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
Participants will receive an intravenous infusion of rituximab on Days 0 and 14
Drug: Rituximab
1000 mg administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of B and T cell subsets among those with and without a long-term response and those with and without baseline anti-RBP antibody
Time Frame: Day 0 through month 24
Day 0 through month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of prolonged B cell absence on the composition and activation status of helper T cell subsets and regulatory T cells
Time Frame: Day 0 through month 24
Day 0 through month 24
Effect of B cell depletion on interferon-alpha activity
Time Frame: Day 0 through month 24
Day 0 through month 24

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)

Investigators

  • Study Chair: Ignacio Sanz, MD, University of Rochester
  • Study Chair: John Looney, MD, University of Rochester

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

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

September 1, 2009

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

October 4, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ALE01

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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