Back to resultsA Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (EXPLORER)
Primary Purpose
Lupus Erythematosus, Systemic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rituximab
Placebo
Prednisone
Acetaminophen
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Rituxan, SLE, Lupus
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Univ of Alabama School of Med; Clinical Immun Rheumatology
- Rheumatology Assoc of North AL
- Arizona Arthritis & Rheumatology Research, Pllc
- Univ of California, San Diego
- Univ of Calif., Los Angeles; Rheumatology
- Cedars-Sinai Medical Center
- Stanford University Med Ctr;Div of Immunology/Rheumatology
- Univ of Calif, San Francisco; Rheumatology
- Eden Medical Center San Leandro Hospital
- University of Colorado Denver
- Arthritis & Rheumatism; Disease Specialities
- Family Arthritis Center
- Emory Uni ; Division of Rheumatology
- Intermountain Research Center
- Coeur D'Alene Arthritis Clinic
- Northwestern University
- Rheumatology Associates
- University of Chicago
- Tri-State Arth & Rheum Center
- Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum
- Kentuckiana Cancer Institute
- LA State Univ; Medicine
- Johns Hopkins Uni
- Center For Rheumatology & Bone Research
- Tufts - New England Medical Center
- Dana-Farber Cancer Institute; Rheumatology
- University Of Michigan
- Michigan Arthritis Rsrch Ctr
- Washington University; Rheumatology Division
- Center for Rheumatology, State Uni. of New York
- SUNY Downstate Medical Center.
- NS-LIJ Health Systems; Rheum-Allergy Clin Immu
- Feinstein Institute for Medical Research
- NYU-Hosp for Joint Diseases; Rheum and Med
- Hospital for Special Surgery
- Buffalo Rheumatology Associates
- Long Island Osteo/Arth Center
- University of Rochester - Strong Memorial Hospital
- University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services
- Duke Medical Center
- Physicians East Pa
- Ohio State University; Division of Nephrology
- Bone and Joint Hospital at St. Anthony Research Department
- Oklahoma Medical Research Foundation
- Oklahoma Center For Arthritis Therapy & Research
- Portland Medical Associates
- East Penn Rheumatology Associates, Pc
- Altoona Arthritis & Osteo Center
- Uni of Pennslyvania Medical Center
- Albert Einstein Medical Center
- University of Pittsburgh
- Medical Univ of South Carolina
- Arthritis Associates PLLC
- Metroplex Clinical Research
- Arthritis Centers of Texas
- Houston Inst. For Clinical Research
- Arthritis & Osteoporosis Associates, LLP
- Texas Research Center
- University of Virginia Med Ctr; Div of Ped Respiratory Med
- Virginia Commonwealth University
- Seattle Rheumatology Assoc; Swedish Rheumatology Research
- Seattle Cancer Care Alliance
- Arthritis Northwest, Spokane
- Univ of Manitoba, Health Scien; Arthritis Centre
- St. Joseph'S Health Care Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rituximab 1000 mg + prednisone
Placebo + prednisone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00137969
Brief Title
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Acronym
EXPLORER
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 10, 2005 (Actual)
Primary Completion Date
August 25, 2008 (Actual)
Study Completion Date
August 25, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Rituxan, SLE, Lupus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab 1000 mg + prednisone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + prednisone
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera, Zytux
Intervention Description
Rituximab will be supplied as a sterile liquid for IV administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be supplied as a sterile liquid for IV administration.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
Description
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
Time Frame
From baseline to 52 weeks
Title
Number of Participants Who Achieved an MCR (Excluding PCR)
Description
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.
Time Frame
From baseline to 52 weeks
Title
Number of Participants Who Achieved a PCR (Including MCR)
Description
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.
Time Frame
From baseline to 52 Weeks
Title
Number of Participants Who Achieved a BILAG C or Better in All Domains
Description
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.
Time Frame
24 weeks
Title
Time to First Moderate or Severe Flare
Description
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.
Time Frame
52 weeks
Title
Change in SLE Expanded Health Survey Physical Function Score From Baseline
Description
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.
Time Frame
From baseline to 52 weeks
Title
Number of Participants Who Achieved an MCR in The ITT Population
Description
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.
Time Frame
From Weeks 24 to 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Brunetta, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Univ of Alabama School of Med; Clinical Immun Rheumatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Rheumatology Assoc of North AL
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, Pllc
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Univ of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Univ of Calif., Los Angeles; Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University Med Ctr;Div of Immunology/Rheumatology
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Univ of Calif, San Francisco; Rheumatology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0111
Country
United States
Facility Name
Eden Medical Center San Leandro Hospital
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Arthritis & Rheumatism; Disease Specialities
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Family Arthritis Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Emory Uni ; Division of Rheumatology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Intermountain Research Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Coeur D'Alene Arthritis Clinic
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rheumatology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Tri-State Arth & Rheum Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LA State Univ; Medicine
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Johns Hopkins Uni
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Center For Rheumatology & Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana-Farber Cancer Institute; Rheumatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5501
Country
United States
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Arthritis Rsrch Ctr
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Facility Name
Washington University; Rheumatology Division
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Rheumatology, State Uni. of New York
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
SUNY Downstate Medical Center.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
NS-LIJ Health Systems; Rheum-Allergy Clin Immu
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU-Hosp for Joint Diseases; Rheum and Med
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Buffalo Rheumatology Associates
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Long Island Osteo/Arth Center
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
University of Rochester - Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Physicians East Pa
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Ohio State University; Division of Nephrology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Bone and Joint Hospital at St. Anthony Research Department
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Center For Arthritis Therapy & Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Portland Medical Associates
City
Portland
State/Province
Oregon
ZIP/Postal Code
97224
Country
United States
Facility Name
East Penn Rheumatology Associates, Pc
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Arthritis & Osteo Center
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Uni of Pennslyvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Arthritis Associates PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Metroplex Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Arthritis Centers of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Inst. For Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Arthritis & Osteoporosis Associates, LLP
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Texas Research Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
University of Virginia Med Ctr; Div of Ped Respiratory Med
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Seattle Rheumatology Assoc; Swedish Rheumatology Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Arthritis Northwest, Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Univ of Manitoba, Health Scien; Arthritis Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1M4
Country
Canada
Facility Name
St. Joseph'S Health Care Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20039413
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
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