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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04963296
Registration number
NCT04963296
Ethics application status
Date submitted
7/07/2021
Date registered
15/07/2021
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
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Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus
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Secondary ID [1]
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2020-005760-57
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Secondary ID [2]
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CA42750
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Universal Trial Number (UTN)
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Trial acronym
ALLEGORY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Placebo
Treatment: Drugs - Acetaminophen/Paracetamol
Treatment: Drugs - Diphenhydramine hydrochloride
Treatment: Drugs - Methylprednisolone
Experimental: Obinutuzumab - Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
Placebo comparator: Placebo - Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
Treatment: Drugs: Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Treatment: Drugs: Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
Treatment: Drugs: Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Treatment: Drugs: Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Treatment: Drugs: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
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Assessment method [1]
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SRI(4) requires reduction from baseline of \>=4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), no new systems or organs affected, as defined by \>=1 new British Isles Lupus Assessment Group (BILAG) A or \>=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of \>=0.30 points on a 3-point Physician's Global Assessment Visual Analogue Scale (PGA-VAS).
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants who Achieve SRI(6) at Week 52
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Assessment method [1]
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SRI(6) requires reduction from baseline of \>=6 points in the SLEDAI-2K, no new systems or organs affected, as defined by \>=1 new BILAG A or \>=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of \>=0.30 points on a 3-point PGA-VAS.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control
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Assessment method [2]
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No treatment with prednisone \>=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.
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Timepoint [2]
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From Week 40 to Week 52
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Secondary outcome [3]
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Time to First BILAG Flare over 52 Weeks
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Assessment method [3]
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Flare is defined as the occurrence of \>=1 new BILAG A or \>=2 new BILAG B manifestations from the previous visit
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Timepoint [3]
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From baseline to Week 52
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Secondary outcome [4]
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Percentage of Participants who Achieve a Sustained SRI(4) Response
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Assessment method [4]
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Achievement of SRI(4) at all study visits from Week 40 through Week 52.
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Timepoint [4]
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From Week 40 to Week 52
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Secondary outcome [5]
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Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
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Assessment method [5]
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Reduction of all baseline BILAG-2004 A items to B/C/D and baseline BILAG-2004 B items to C/D; no new systems or organs affected, as defined by \>=1 new BILAG A or \>=2 new BILAG B items compared with baseline; no net increase in SLEDAI-2K score from baseline; and no worsening from baseline of \>=0.30 points on a 3-point PGA-VAS.
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Percentage of Participants who Achieve SRI(8) at Week 52
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Assessment method [6]
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Percentage of Participants who Achieve SRI(4) at Week 24
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Assessment method [7]
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Percentage of Participants who Achieve Clinical SRI(4) at Week 52
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Assessment method [8]
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Timepoint [8]
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Week 52
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Secondary outcome [9]
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Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids
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Assessment method [9]
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Timepoint [9]
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Week 52
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Secondary outcome [10]
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Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52
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Assessment method [10]
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Timepoint [10]
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Week 52
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Secondary outcome [11]
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Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52
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Assessment method [11]
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Timepoint [11]
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Week 52
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Secondary outcome [12]
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Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
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Assessment method [12]
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Timepoint [12]
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From baseline to Week 24 and from baseline to Week 52
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Secondary outcome [13]
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Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
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Assessment method [13]
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Timepoint [13]
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From baseline to Week 24 and from baseline to Week 52
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Secondary outcome [14]
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Change in SF-36 v2 Physical Component Summary Scale
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Assessment method [14]
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Timepoint [14]
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From baseline to Week 24 and from baseline to Week 52
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Secondary outcome [15]
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Change in Active Joint Count (Swollen plus Tender)
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Assessment method [15]
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Timepoint [15]
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From baseline to Week 24 and from baseline to Week 52
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Secondary outcome [16]
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Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit
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Assessment method [16]
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Timepoint [16]
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From baseline to Week 52
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Secondary outcome [17]
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Percentage of Participants who Achieve a >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at each Study Visit, among Participants with CLASI Total Activity Score >=10 at Baseline
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Assessment method [17]
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Timepoint [17]
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From baseline to Week 52
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Secondary outcome [18]
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Percentage of Participants who Achieve Sustained Corticosteroid Control
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Assessment method [18]
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Timepoint [18]
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From Week 40 through Week 52
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Secondary outcome [19]
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Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)
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Assessment method [19]
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Timepoint [19]
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From baseline to Week 52
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Secondary outcome [20]
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Annualized flare rate through Week 52
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Assessment method [20]
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Timepoint [20]
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At Week 52
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Secondary outcome [21]
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Percentage of Participants with Adverse Events
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Assessment method [21]
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Timepoint [21]
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From baseline to approximately 6 years
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Secondary outcome [22]
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Percentage of Participants with Adverse Events of Special Interest (AESIs)
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Assessment method [22]
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Timepoint [22]
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From baseline to approximately 6 years
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Secondary outcome [23]
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Serum Concentration of Obinutuzumab
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Assessment method [23]
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Timepoint [23]
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Double blind period: At Weeks 2, 4, 12, 24, 26, 36, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 58, 66, 78, 90, 104 and at early study discontinuation visit
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Secondary outcome [24]
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Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline
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Assessment method [24]
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Timepoint [24]
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Baseline
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Secondary outcome [25]
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Percentage of Participants with ADAs During the Study
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Assessment method [25]
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Timepoint [25]
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Up to approximately 6 years
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Eligibility
Key inclusion criteria
* Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria >=12 weeks prior to screening
* Anti-nuclear antibody (ANA) >=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
* Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening
* High disease activity at screening, based on; BILAG-2004 (Category A disease in >=1 organ system and/or Category B disease in >=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score >=8) and Physician's Global Assessment (PGA) (score >=1.0 on a 0 to 3 visual analogue scale [VAS])
* High disease activity on Day 1, based on; SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS)
* Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
* Other inclusion criteria may apply
* The Medical Monitor may be consulted if there are any questions related to eligibility criteria
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnancy or breastfeeding
* Presence of significant lupus-associated renal disease and/or renal impairment
* Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
* Known active infection of any kind or recent major episode of infection
* Intolerance or contraindication to study therapies
* Other exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2027
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Alabama
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Arkansas
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Ciudad Autónoma de Buenos Aires
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Argentina
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San Miguel
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Argentina
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San Nicolás
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Brazil
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BA
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Brazil
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MG
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Brazil
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Brest
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Le Kremlin Bicetre
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France
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Nice
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France
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Paris
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France
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Rennes
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Strasbourg
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Lazio
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Italy
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Veneto
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BAJA California
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Coahuila
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Nuevo LEON
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Auckland
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Wellington
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Peru
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Arequipa
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Peru
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Lima
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Peru
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Rjazan
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Chatsworth
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Port Elizabeth
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Pretoria
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Somerset West
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Umhlanga
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LA Coruña
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Pontevedra
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Barcelona
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Madrid
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Cambridge
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Derby
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Leeds
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Liverpool
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London
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Manchester
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United Kingdom
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Preston
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.
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Trial website
https://clinicaltrials.gov/study/NCT04963296
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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Clinical Trials
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Address
0
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Hoffmann-La Roche
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Phone
0
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: CA42750 https://forpatients.roche.com/
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Address
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Country
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Phone
0
0
888-662-6728 (U.S. and Canada)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04963296