NCT01702038

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

First QC Date

October 3, 2012

Last Update Submit

October 4, 2012

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0 through month 24

Secondary Outcomes (2)

  • Impact of prolonged B cell absence on the composition and activation status of helper T cell subsets and regulatory T cells

    Day 0 through month 24

  • Effect of B cell depletion on interferon-alpha activity

    Day 0 through month 24

Study Arms (1)

Rituximab

EXPERIMENTAL

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

Drug: Rituximab

Interventions

RituximabDRUG

1000 mg administered intravenously

Rituximab

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

  • 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.

    PMID: 17214580BACKGROUND

  • 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.

    PMID: 18095917BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ignacio Sanz, MD

    University of Rochester

    STUDY CHAIR

  • John Looney, MD

    University of Rochester

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

September 1, 2009

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations

US(2)