search
Back to results

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

Primary Purpose

Lupus Erythematosus, Systemic

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab

Arm Description

Participants will receive an intravenous infusion of rituximab on Days 0 and 14

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Impact of prolonged B cell absence on the composition and activation status of helper T cell subsets and regulatory T cells
Effect of B cell depletion on interferon-alpha activity

Full Information

First Posted
October 3, 2012
Last Updated
October 4, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT01702038
Brief Title
Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
Official Title
Rituximab in SLE: Understanding of Long-term Responses and the Impact of B Cell Depletion on T Cells
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Study Start Date
September 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab
Arm Type
Experimental
Arm Description
Participants will receive an intravenous infusion of rituximab on Days 0 and 14
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
1000 mg administered intravenously
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Effect of B cell depletion on interferon-alpha activity
Time Frame
Day 0 through month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Sanz, MD
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Looney, MD
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17214580
Citation
Eisenberg R. Targeting B cells in SLE: the experience with rituximab treatment (anti-CD20). Endocr Metab Immune Disord Drug Targets. 2006 Dec;6(4):345-50. doi: 10.2174/187153006779025757.
Results Reference
background
PubMed Identifier
18095917
Citation
Pego-Reigosa JM, Isenberg DA. Systemic lupus erythematosus: pharmacological developments and recommendations for a therapeutic strategy. Expert Opin Investig Drugs. 2008 Jan;17(1):31-41. doi: 10.1517/13543784.17.1.31.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs