Lupus Erythematosus, SystemicPhase 2NCT01702038
Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
A Phase 2 study testing Rituximab in people with Lupus Erythematosus, Systemic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 65 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
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to not given
- Phase
- Phase 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Rochester
Rochester, New York, 14642
About this study
Official title: 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).
Read the 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.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- 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
1000 mg administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Participants will receive an intravenous infusion of rituximab on Days 0 and 14 Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 0 through month 24
Effect of B cell depletion on interferon-alpha activity
Measured: Day 0 through month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ignacio Sanz, MD, Study chair, University of RochesterJohn Looney, MD, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702038
- Sponsor's protocol ID
- DAIT ALE01
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 8 Oct 2012
- 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 17214580Pego-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.
PubMed 18095917
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab in SLE: Understanding of Long-term Responses and the Impact of B Cell Depletion on T Cells
- ClinicalTrials.gov ID
- NCT01702038
- Acronym / sponsor ID
- DAIT ALE01
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2009
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: RituximabParticipants will receive an intravenous infusion of rituximab on Days 0 and 14 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab1000 mg administered intravenously | Drug | Rituximab |
Primary outcome
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
2 secondary outcomes
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
Effect of B cell depletion on interferon-alpha activity
Time frame: Day 0 through month 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
- Background: PubMed 17214580Eisenberg 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.
- Background: PubMed 18095917Pego-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Sanz, MD study chair
University of Rochester
John Looney, MD study chair
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Lupus Erythematosus, Systemic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 4 inclusion and 26 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: withdrawn, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
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). 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 NCT01702038, which also lists 2 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 8 Oct 2012.