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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab will be supplied as a sterile liquid for IV administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Brunetta, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama School of Med; Clinical Immun Rheumatology | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20039413 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab 1000 mg + Prednisone | Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo will be supplied as a sterile liquid for IV administration. |
|
| Prednisone | Drug |
|
| Acetaminophen | Drug |
|
| Diphenhydramine | Drug |
|
| 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. | 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. | 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. | 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. | 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. | 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. | From Weeks 24 to 52 |
| Rheumatology Assoc of North AL |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Arizona Arthritis & Rheumatology Research, Pllc | Paradise Valley | Arizona | 85253 | United States |
| Univ of California, San Diego | La Jolla | California | 92037 | United States |
| Univ of Calif., Los Angeles; Rheumatology | Los Angeles | California | 90025 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Stanford University Med Ctr;Div of Immunology/Rheumatology | Palo Alto | California | 94304 | United States |
| Univ of Calif, San Francisco; Rheumatology | San Francisco | California | 94143-0111 | United States |
| Eden Medical Center San Leandro Hospital | San Leandro | California | 94578 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Arthritis & Rheumatism; Disease Specialities | Aventura | Florida | 33180 | United States |
| Family Arthritis Center | Jupiter | Florida | 33458 | United States |
| Emory Uni ; Division of Rheumatology | Atlanta | Georgia | 30303 | United States |
| Intermountain Research Center | Boise | Idaho | 83702 | United States |
| Coeur D'Alene Arthritis Clinic | Coeur d'Alene | Idaho | 83814 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rheumatology Associates | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Tri-State Arth & Rheum Center | Evansville | Indiana | 47714 | United States |
| Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum | Kansas City | Kansas | 66160 | United States |
| Kentuckiana Cancer Institute | Louisville | Kentucky | 40202 | United States |
| LA State Univ; Medicine | Shreveport | Louisiana | 71103 | United States |
| Johns Hopkins Uni | Baltimore | Maryland | 21205 | United States |
| Center For Rheumatology & Bone Research | Wheaton | Maryland | 20902 | United States |
| Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Dana-Farber Cancer Institute; Rheumatology | Boston | Massachusetts | 02215-5501 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Michigan Arthritis Rsrch Ctr | Brighton | Michigan | 48116 | United States |
| Washington University; Rheumatology Division | St Louis | Missouri | 63110 | United States |
| Center for Rheumatology, State Uni. of New York | Albany | New York | 12206 | United States |
| SUNY Downstate Medical Center. | Brooklyn | New York | 11203 | United States |
| NS-LIJ Health Systems; Rheum-Allergy Clin Immu | Lake Success | New York | 11042 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| NYU-Hosp for Joint Diseases; Rheum and Med | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Buffalo Rheumatology Associates | Orchard Park | New York | 14127 | United States |
| Long Island Osteo/Arth Center | Plainview | New York | 11803 | United States |
| University of Rochester - Strong Memorial Hospital | Rochester | New York | 14642 | United States |
| University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services | Chapel Hill | North Carolina | 27514 | United States |
| Duke Medical Center | Durham | North Carolina | 27710 | United States |
| Physicians East Pa | Greenville | North Carolina | 27834 | United States |
| Ohio State University; Division of Nephrology | Columbus | Ohio | 43210 | United States |
| Bone and Joint Hospital at St. Anthony Research Department | Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Center For Arthritis Therapy & Research | Tulsa | Oklahoma | 74104 | United States |
| Portland Medical Associates | Portland | Oregon | 97224 | United States |
| East Penn Rheumatology Associates, Pc | Bethlehem | Pennsylvania | 18015 | United States |
| Altoona Arthritis & Osteo Center | Duncansville | Pennsylvania | 16635 | United States |
| Uni of Pennslyvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical Univ of South Carolina | Charleston | South Carolina | 29425 | United States |
| Arthritis Associates PLLC | Chattanooga | Tennessee | 37404 | United States |
| Metroplex Clinical Research | Dallas | Texas | 75231 | United States |
| Arthritis Centers of Texas | Dallas | Texas | 75246 | United States |
| Houston Inst. For Clinical Research | Houston | Texas | 77074 | United States |
| Arthritis & Osteoporosis Associates, LLP | Lubbock | Texas | 79424 | United States |
| Texas Research Center | Sugar Land | Texas | 77479 | United States |
| University of Virginia Med Ctr; Div of Ped Respiratory Med | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Seattle Rheumatology Assoc; Swedish Rheumatology Research | Seattle | Washington | 98104 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Arthritis Northwest, Spokane | Spokane | Washington | 99204 | United States |
| Univ of Manitoba, Health Scien; Arthritis Centre | Winnipeg | Manitoba | R3A1M4 | Canada |
| St. Joseph'S Health Care Centre | London | Ontario | N6A 4V2 | Canada |
| FG001 | Placebo + Prednisone | Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Intent-to-treat population: All randomized participants who received any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab 1000 mg + Prednisone | Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
| BG001 | Placebo + Prednisone | Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat (ITT) population | Posted | Number | Participants | From baseline to 52 weeks |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | BILAG score unit | From baseline to 52 weeks |
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| Secondary | 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. | ITT population | Posted | Number | participants | From baseline to 52 weeks |
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| Secondary | 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. | ITT population | Posted | Number | participants | From baseline to 52 Weeks |
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| Secondary | 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. | ITT population | Posted | Number | participants | 24 weeks |
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| Secondary | 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. | Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis. | Posted | Median | 95% Confidence Interval | days | 52 weeks |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | score on a scale | From baseline to 52 weeks |
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| Secondary | 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. | ITT population | Posted | Number | participants | From Weeks 24 to 52 |
|
From the beginning to the end of the study (Week 78 plus extended safety follow-up, with an average duration of 96 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab 1000 mg + Prednisone | Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. | 72 | 169 | 164 | 169 | ||
| EG001 | Placebo + Prednisone | Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. | 32 | 88 | 85 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lymphophenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diastolic Dysfunction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric Ulcer Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diverticular Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peptic Ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Serum Sickness | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia Primary Atypical | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess Intestinal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Appendiceal Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes Virus Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroentiritis Viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cytomegalovirus Colitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Genital Infection Female | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroentiritis Salmonella | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal Bacteremia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Incision Hernia | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| International Normalised Ratio Abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| SLE Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebellar Haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Reversible Posterior Leukoencephalopathy Syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Spinal Cord Herniation | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Premature Labor | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anxiety Disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lupus Nephritis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary Alveolar Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abortion Induced | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lupus Vasculitis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Febrile Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Disseminated Cytomegaloviral Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Viral Oesaphagitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mental Status Change | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hidradentis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Venous Insufficiency | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Substance-induced Psychotic Disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D011241 | Prednisone |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| 20 to 64 years |
|
| > 64 years |
|
| Male |
|
| Nonclinical Response (NCR) |
|
|
|
|
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
|
|
|
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received 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 also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. |
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