Lupus Erythematosus, SystemicPhase 2/3EXPLORERNCT00137969
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
A Phase 2/3 study testing Rituximab, Prednisone and Acetaminophen in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 65 sites in 2 countries.
Trial summary
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Rituximab, Prednisone and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 65 sitesin 2 countries
- Study dates
- 10 May 2005to 25 Aug 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of systemic lupus erythematosus (SLE).
- Active disease at screening.
- Stable use of one immunosuppressive drug.
- Use of an antimalarial drug.
- For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.
Who cannot join
- Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
- Active moderate to severe glomerulonephritis.
- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
- Lack of peripheral venous access.
- Pregnant women or nursing (breast feeding) mothers.
- History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
Show all 25Show fewer
- Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
- Concomitant conditions that require oral or systemic corticosteroid use.
- Known human immunodeficiency virus (HIV) infection.
- Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
- History of deep space infection.
- History of serious recurrent or chronic infection.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
- Active alcohol or drug abuse, or history of alcohol or drug abuse.
- Major surgery.
- Previous treatment with CAMPATH-1H antibody.
- Previous treatment with any B cell-targeted therapy.
- Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
- Receipt of a live vaccine within 28 days prior to screening.
- Intolerance or contraindication to oral or IV corticosteroids.
- Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
- Prednisone dose of ≥ 1 mg/kg/day prior to screening.
- Treatment with cyclophosphamide or a calcineurin inhibitor.
- Treatment with a second immunosuppressive or immunomodulatory drug.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x the upper limit of normal.
Trial locations and contacts
65 sites in 2 countries.
65 sites in 2 countries
United States63 sites
Center for Rheumatology, State Uni. of New York
Albany, New York, 12206
University Of Michigan
Ann Arbor, Michigan, 48109
Emory Uni ; Division of Rheumatology
Atlanta, Georgia, 30303
University of Colorado Denver
Aurora, Colorado, 80045
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, 33180
Johns Hopkins Uni
Baltimore, Maryland, 21205
East Penn Rheumatology Associates, Pc
Bethlehem, Pennsylvania, 18015
Univ of Alabama School of Med; Clinical Immun Rheumatology
Birmingham, Alabama, 35294
Intermountain Research Center
Boise, Idaho, 83702
Tufts - New England Medical Center
Boston, Massachusetts, 02111
Dana-Farber Cancer Institute; Rheumatology
Boston, Massachusetts, 02215-5501
Michigan Arthritis Rsrch Ctr
Brighton, Michigan, 48116
SUNY Downstate Medical Center.
Brooklyn, New York, 11203
University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services
Chapel Hill, North Carolina, 27514
Medical Univ of South Carolina
Charleston, South Carolina, 29425
University of Virginia Med Ctr; Div of Ped Respiratory Med
Charlottesville, Virginia, 22908
Arthritis Associates PLLC
Chattanooga, Tennessee, 37404
Northwestern University
Chicago, Illinois, 60611
Rheumatology Associates
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814
Ohio State University; Division of Nephrology
Columbus, Ohio, 43210
Metroplex Clinical Research
Dallas, Texas, 75231
Arthritis Centers of Texas
Dallas, Texas, 75246
Altoona Arthritis & Osteo Center
Duncansville, Pennsylvania, 16635
Duke Medical Center
Durham, North Carolina, 27710
Tri-State Arth & Rheum Center
Evansville, Indiana, 47714
Physicians East Pa
Greenville, North Carolina, 27834
Houston Inst. For Clinical Research
Houston, Texas, 77074
Rheumatology Assoc of North AL
Huntsville, Alabama, 35801
Family Arthritis Center
Jupiter, Florida, 33458
Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum
Kansas City, Kansas, 66160
Univ of California, San Diego
La Jolla, California, 92037
NS-LIJ Health Systems; Rheum-Allergy Clin Immu
Lake Success, New York, 11042
Univ of Calif., Los Angeles; Rheumatology
Los Angeles, California, 90025
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, 79424
Feinstein Institute for Medical Research
Manhasset, New York, 11030
NYU-Hosp for Joint Diseases; Rheum and Med
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Bone and Joint Hospital at St. Anthony Research Department
Oklahoma City, Oklahoma, 73103
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Buffalo Rheumatology Associates
Orchard Park, New York, 14127
Stanford University Med Ctr;Div of Immunology/Rheumatology
Palo Alto, California, 94304
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, 85253
Uni of Pennslyvania Medical Center
Philadelphia, Pennsylvania, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Long Island Osteo/Arth Center
Plainview, New York, 11803
Portland Medical Associates
Portland, Oregon, 97224
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester - Strong Memorial Hospital
Rochester, New York, 14642
Univ of Calif, San Francisco; Rheumatology
San Francisco, California, 94143-0111
Eden Medical Center San Leandro Hospital
San Leandro, California, 94578
Seattle Rheumatology Assoc; Swedish Rheumatology Research
Seattle, Washington, 98104
Seattle Cancer Care Alliance
Seattle, Washington, 98109
LA State Univ; Medicine
Shreveport, Louisiana, 71103
Arthritis Northwest, Spokane
Spokane, Washington, 99204
Washington University; Rheumatology Division
St Louis, Missouri, 63110
Texas Research Center
Sugar Land, Texas, 77479
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, 74104
Center For Rheumatology & Bone Research
Wheaton, Maryland, 20902
Canada2 sites
St. Joseph'S Health Care Centre
London, Ontario, N6A 4V2
Univ of Manitoba, Health Scien; Arthritis Centre
Winnipeg, Manitoba, R3A1M4
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Rituximab, Placebo, Prednisone, Acetaminophen, Diphenhydramine
- Keywords
- Rituxan, SLE, Lupus
- 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, MabThera, Zytux
Rituximab will be supplied as a sterile liquid for IV administration.
PlaceboDrug
Placebo will be supplied as a sterile liquid for IV administration.
PrednisoneDrug
AcetaminophenDrug
DiphenhydramineDrug
| Study group | Role | What they receive |
|---|---|---|
| Rituximab 1000 mg + prednisone | Experimental | Participants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. Receives: Drug: Rituximab; Drug: Prednisone; Drug: Acetaminophen; Drug: Diphenhydramine |
| Placebo + prednisone | Placebo comparator | Participants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. Receives: Drug: Placebo; Drug: Prednisone; Drug: Acetaminophen; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.
Measured: From baseline to 52 weeks
Secondary outcomes (7)
Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as: 1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks. 2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study. 3. Minus the Time-Adjusted AUC by the baseline BILAG global score
Measured: From baseline to 52 weeks
Number of Participants Who Achieved an MCR (Excluding PCR)
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.
Measured: From baseline to 52 weeks
Number of Participants Who Achieved a PCR (Including MCR)
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.
Measured: From baseline to 52 Weeks
Number of Participants Who Achieved a BILAG C or Better in All Domains
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains.
Measured: 24 weeks
Time to First Moderate or Severe Flare
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state.
Measured: 52 weeks
Change in SLE Expanded Health Survey Physical Function Score From Baseline
Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved.
Measured: From baseline to 52 weeks
Number of Participants Who Achieved an MCR in The ITT Population
The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.
Measured: From Weeks 24 to 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study start10 May 2005
- Primary completion25 Aug 2008
- Study completion25 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Genentech, Inc.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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Brunetta, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137969
- Sponsor's protocol ID
- U2971g
- Acronym
- EXPLORER
- Status last verified
- Jun 2017
- First submitted
- 26 Aug 2005
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.
PubMed 20039413
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00137969
- Acronym / sponsor ID
- EXPLORER / U2971g
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Rituxan, SLE, Lupus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2005 (actual)
- Primary completion
- 25 Aug 2008 (actual)
- Study completion
- 25 Aug 2008 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Posted 10 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab 1000 mg + prednisone | Experimental | Drug: Rituximab, Drug: Prednisone, Drug: Acetaminophen, Drug: DiphenhydramineParticipants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
| Placebo + prednisone | Placebo comparator | Drug: Placebo, Drug: Prednisone, Drug: Acetaminophen, Drug: DiphenhydramineParticipants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of systemic lupus erythematosus (SLE).
- Active disease at screening.
- Stable use of one immunosuppressive drug.
- Use of an antimalarial drug.
- For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.
Key exclusion criteria (25 listed)
- Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
- Active moderate to severe glomerulonephritis.
- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
- Lack of peripheral venous access.
- Pregnant women or nursing (breast feeding) mothers.
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 |
|---|---|---|
| RituximabAlso: Rituxan, MabThera, ZytuxRituximab will be supplied as a sterile liquid for IV administration. | Drug | Rituximab 1000 mg + prednisone |
| PlaceboPlacebo will be supplied as a sterile liquid for IV administration. | Drug | Placebo + prednisone |
| Prednisone | Drug | Placebo + prednisone, Rituximab 1000 mg + prednisone |
| Acetaminophen | Drug | Placebo + prednisone, Rituximab 1000 mg + prednisone |
| Diphenhydramine | Drug | Placebo + prednisone, Rituximab 1000 mg + prednisone |
Primary outcome
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
Time frame: From baseline to 52 weeks
The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.
7 secondary outcomes
Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
Time frame: From baseline to 52 weeks
Number of Participants Who Achieved an MCR (Excluding PCR)
Time frame: From baseline to 52 weeks
Number of Participants Who Achieved a PCR (Including MCR)
Time frame: From baseline to 52 Weeks
Number of Participants Who Achieved a BILAG C or Better in All Domains
Time frame: 24 weeks
Time to First Moderate or Severe Flare
Time frame: 52 weeks
Change in SLE Expanded Health Survey Physical Function Score From Baseline
Time frame: From baseline to 52 weeks
Number of Participants Who Achieved an MCR in The ITT Population
Time frame: From Weeks 24 to 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20039413Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.
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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.
Paul Brunetta, M.D. study director
Genentech, Inc.
65 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rituximab, Prednisone and Acetaminophen in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 65 sites in 2 countries.
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 5 inclusion and 25 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period (time frame: From baseline to 52 weeks). 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 NCT00137969, which also lists 1 linked publication.
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 20 Aug 2019.