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Lupus Erythematosus, SystemicPhase 1/2NCT00036491

Anti-CD20 in Systemic Lupus Erythematosus

A Phase 1/2 study testing Rituximab in people with Lupus Erythematosus, Systemic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesUnited States
Study dates
Jan 2001to Jan 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Colorado

    Denver, Colorado, 80045

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Rochester

    Rochester, New York, 14623

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Rituximab
Keywords
Systemic Lupus Erythematosus, SLE, B-Lymphocytes, anti-CD20, rituximab
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Rituxan®

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

Study groups in NCT00036491
Study groupRoleWhat they receive
rituximabExperimental375 mg/m^2 administered intravenously
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Autoantibodies

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

  2. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

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

Secondary outcomes (11)

  1. C3 and C4 complement levels

  2. Systemic Lupus Activity Measure (SLAM)

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

  3. Erythrocyte Sedimentation Rate (ESR)

  4. Prednisone Dose

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

  5. Renal Function

    Measured by creatinine clearance and total protein.

  6. Modified Health Assessment Questionnaire (HAQ)

  7. Short Form-36 Health Survey (SF-36)

  8. Physician Global Assessment (VAS)

  9. Patient Global Assessment (VAS)

  10. Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index for SLE

  11. Adverse Events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2002 (estimated)
  2. Study startJan 2001
  3. Primary completionJan 2006
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036491
Sponsor's protocol ID
DAIT AC002
Other IDs
SACCC #ASL02, UPenn #U1131s, ACE Study #AC002
Status last verified
Nov 2017
First submitted
10 May 2002
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17214580

  • 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.

    PubMed 18226586

  • 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.

    PubMed 18250115

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rituximab in people with Lupus Erythematosus, Systemic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Autoantibodies (time frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00036491, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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