NCT00036491

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

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

January 1, 2001

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

5 years

First QC Date

May 10, 2002

Last Update Submit

November 1, 2017

Conditions

Lupus Erythematosus, Systemic

Keywords

Systemic Lupus ErythematosusSLEB-Lymphocytesanti-CD20rituximab

Outcome Measures

Primary Outcomes (2)

  • Serum Autoantibodies

    Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56

  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

    Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55

Secondary Outcomes (11)

  • C3 and C4 complement levels

  • Systemic Lupus Activity Measure (SLAM)

    Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55

  • Erythrocyte Sedimentation Rate (ESR)

  • Prednisone Dose

    Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56

  • Renal Function

  • +6 more secondary outcomes

Study Arms (1)

rituximab

EXPERIMENTAL

375 mg/m\^2 administered intravenously

Drug: Rituximab

Interventions

RituximabDRUG

Subjects received four weekly infusions of rituximab at a dose of 375 mg/m\^2

Also known as: Rituxan®
rituximab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Rochester

Rochester, New York, 14623, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • 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

  • Sutter JA, Kwan-Morley J, Dunham J, Du YZ, Kamoun M, Albert D, Eisenberg RA, Luning Prak ET. A longitudinal analysis of SLE patients treated with rituximab (anti-CD20): factors associated with B lymphocyte recovery. Clin Immunol. 2008 Mar;126(3):282-90. doi: 10.1016/j.clim.2007.11.012. Epub 2008 Jan 15.

    PMID: 18226586BACKGROUND

  • Albert D, Dunham J, Khan S, Stansberry J, Kolasinski S, Tsai D, Pullman-Mooar S, Barnack F, Striebich C, Looney RJ, Prak ET, Kimberly R, Zhang Y, Eisenberg R. Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus. Ann Rheum Dis. 2008 Dec;67(12):1724-31. doi: 10.1136/ard.2007.083162. Epub 2008 Feb 4.

    PMID: 18250115RESULT

Related Links

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

  • Robert A. Eisenberg, MD

    University of Pennsylvania

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2002

First Posted

May 13, 2002

Study Start

January 1, 2001

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(3)