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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus (ALLEGORY)

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obinutuzumab
Placebo
Acetaminophen/Paracetamol
Diphenhydramine hydrochloride
Methylprednisolone
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 and/or low C4 and/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

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

Sites / Locations

  • Pinnacle Research Group; Llc, CentralRecruiting
  • University of Alabama; Kirklin ClinicRecruiting
  • Unity Health - White County Medical Center- RheumatologyRecruiting
  • Providence Medical FoundationRecruiting
  • Inland Rheumatology Clinical Trials IncorporatedRecruiting
  • University of Colorado Denver, Barbara Davis Center, Center For Clinical ResearchRecruiting
  • Arthritis & Rheumatism; Disease SpecialitiesRecruiting
  • : Reliant Medical ResearchRecruiting
  • Rheumatology Associates of Central Florida
  • Adventhealth Medical Group ? Tampa ? IM/Rheumatology
  • Arthritis & Rheumatology of Georgia
  • Klein & Associates, M.D., P.A.Recruiting
  • Great Lakes Center of RheumatologyRecruiting
  • Clinical Research Institute of Michigan, LLCRecruiting
  • Suny Downstate Medical Center; Rheumatology
  • Northwell Health Division of RheumatologyRecruiting
  • Columbia University Medical Center; Division of RheumatologyRecruiting
  • Joint & Muscle Research InstituteRecruiting
  • DJL Clinical Research PLLCRecruiting
  • The Ohio State University Wexner Medical Center
  • Paramount Medical Research & Consulting, LLCRecruiting
  • Amarillo Center For Clinical ResearchRecruiting
  • Precision Comprehensive Clinical Research Solutions
  • Prolato Clinical Research CenterRecruiting
  • DOM Centro de ReumatologíaRecruiting
  • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGYRecruiting
  • Organizacion Medica de InvestigacionRecruiting
  • Ser Servicos Especializados Em ReumatologiaRecruiting
  • Santa Casa de Misericordia; de Belo Horizonte
  • Hospital das Clinicas - UFMGRecruiting
  • Centro Mineiro de Pesquisa - CMIP
  • Centro de Estudos em Terapias Inovadoras ? CETI
  • Hospital das Clinicas - FMUSP Ribeirao Preto; ReumatologiaRecruiting
  • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*Recruiting
  • Revmatologicky UstavRecruiting
  • Hopital La Cavale Blanche; RhumatologieRecruiting
  • CH de Bicêtre; Rhumatologie
  • Hopital de L'Archet; Medecine InterneRecruiting
  • Ch Pitie Salpetriere; Medecine Interne I
  • HOPITAL COCHIN; Internal Medicine DepartmentRecruiting
  • Hôpital Sud - CHU de Rennes Service interneRecruiting
  • Hopital Hautepierre; Rhumatologie
  • Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna; ReumatologiaRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia ClinicaRecruiting
  • IRCCS S. Raffaele; U.O. Immunologia, Reumatologia, Allergologia e Malattie RareRecruiting
  • A.O. Universitaria Pisana
  • Uni Di Padova; Divisione Di RheumatologiaRecruiting
  • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del AngelRecruiting
  • Centro de Investigacion Alberto Bazzoni S.A. de C.V.Recruiting
  • Centro de Investigación y Tratamiento Reumatológico S.C.Recruiting
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
  • Middlemore Hospital; Dept of RheumatologyRecruiting
  • Wellington HospitalRecruiting
  • Hogar Clínica San Juan de DiosRecruiting
  • Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJBRecruiting
  • Instituto de Ginecología y Reproducción
  • Clinica El GolfRecruiting
  • Clinica Peruana AmericanaRecruiting
  • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
  • Medyczne Centrum HetmanskaRecruiting
  • Prywatna Praktyka Lekarska; Prof.UM dr hab.med Pawel Hryc
  • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob WewnetrznychRecruiting
  • MICS Centrum Medyczne Warszawa
  • Rheuma Medicus Zaklad Opieki ZdrowotnejRecruiting
  • REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka JawnaRecruiting
  • Republican clinical hospital named after G.G. KuvatovRecruiting
  • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital 9"Recruiting
  • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. NasonovaRecruiting
  • SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RFRecruiting
  • Ryazan State Medical University Named after I.P.Pavlov
  • FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health
  • Center of Family Medicine LCRecruiting
  • Scient Res Med Ctr Your HealthRecruiting
  • SBHI of Yaroslavl Region Clinical Hospital #3
  • Panorama Medical Center; RheumatologyRecruiting
  • TREAD Research
  • Winelands Medical Research; Medical ResearchRecruiting
  • Precise Clinical Solutions (Pty) Ltd
  • Metropolitan Clinical Research Institute
  • Greenacres Hospital
  • Emmed ResearchRecruiting
  • Mediclinic VergelegenRecruiting
  • Netcare Umhlanga Medical Centre; RheumatologyRecruiting
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina InternaRecruiting
  • Hospital MeixoeiroRecruiting
  • Hospital de Basurto; Servicio de ReumatologiaRecruiting
  • Hospital Universitario Vall d'Hebron; Servicio de Medicina InternaRecruiting
  • Hospital Clinic i Provincial de Barcelona; Enfermedades AutoinmmunesRecruiting
  • Hospital General Universitario Gregorio Marañon; Servicio de ReumatologíaRecruiting
  • Addenbrooke'S Hospital; Rheumatology Research Unit
  • Royal Derby HospitalRecruiting
  • Chapel Allerton Hospital; Leeds Institution of Rheumatology MedicineRecruiting
  • Aintree University Hospitals NHS Foundation TrustRecruiting
  • Royal Free Hospital; Department of Rheumatology
  • Guy's Hospital; Louise Coote Lupus UnitRecruiting
  • Manchester Royal Infirmary; Kellgren Centre for RheumatologyRecruiting
  • Lancashire Teaching Hospitals NHS Foundation Trust; Lancashire Clinical Research FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Obinutuzumab

Placebo

Arm Description

Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.

Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.

Outcomes

Primary Outcome Measures

Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
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).

Secondary Outcome Measures

Percentage of Participants who Achieve SRI(6) at Week 52
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.
Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control
No treatment with prednisone >=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.
Time to First BILAG Flare over 52 Weeks
Flare is defined as the occurrence of >=1 new BILAG A or >=2 new BILAG B manifestations from the previous visit
Percentage of Participants who Achieve a Sustained SRI(4) Response
Achievement of SRI(4) at all study visits from Week 40 through Week 52.
Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
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.
Percentage of Participants who Achieve SRI(8) at Week 52
Percentage of Participants who Achieve SRI(4) at Week 24
Percentage of Participants who Achieve Clinical SRI(4) at Week 52
Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52
Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
Change in SF-36 v2 Physical Component Summary Scale
Change in Active Joint Count (Swollen plus Tender)
Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit
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
Percentage of Participants who Achieve Sustained Corticosteroid Control
Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)
Annualized flare rate through Week 52
Percentage of Participants with Adverse Events
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Serum Concentration of Obinutuzumab
Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline
Percentage of Participants with ADAs During the Study

Full Information

First Posted
July 7, 2021
Last Updated
October 17, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04963296
Brief Title
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Acronym
ALLEGORY
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obinutuzumab
Arm Type
Experimental
Arm Description
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva, GA101, RO5072759
Intervention Description
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/Paracetamol
Intervention Description
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine hydrochloride
Intervention Description
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
Description
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).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve SRI(6) at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control
Description
No treatment with prednisone >=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.
Time Frame
From Week 40 to Week 52
Title
Time to First BILAG Flare over 52 Weeks
Description
Flare is defined as the occurrence of >=1 new BILAG A or >=2 new BILAG B manifestations from the previous visit
Time Frame
From baseline to Week 52
Title
Percentage of Participants who Achieve a Sustained SRI(4) Response
Description
Achievement of SRI(4) at all study visits from Week 40 through Week 52.
Time Frame
From Week 40 to Week 52
Title
Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants who Achieve SRI(8) at Week 52
Time Frame
Week 52
Title
Percentage of Participants who Achieve SRI(4) at Week 24
Time Frame
Week 24
Title
Percentage of Participants who Achieve Clinical SRI(4) at Week 52
Time Frame
Week 52
Title
Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids
Time Frame
Week 52
Title
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52
Time Frame
Week 52
Title
Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52
Time Frame
Week 52
Title
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Time Frame
From baseline to Week 24 and from baseline to Week 52
Title
Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
Time Frame
From baseline to Week 24 and from baseline to Week 52
Title
Change in SF-36 v2 Physical Component Summary Scale
Time Frame
From baseline to Week 24 and from baseline to Week 52
Title
Change in Active Joint Count (Swollen plus Tender)
Time Frame
From baseline to Week 24 and from baseline to Week 52
Title
Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit
Time Frame
From baseline to Week 52
Title
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
Time Frame
From baseline to Week 52
Title
Percentage of Participants who Achieve Sustained Corticosteroid Control
Time Frame
From Week 40 through Week 52
Title
Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)
Time Frame
From baseline to Week 52
Title
Annualized flare rate through Week 52
Time Frame
At Week 52
Title
Percentage of Participants with Adverse Events
Time Frame
From baseline to approximately 6 years
Title
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Time Frame
From baseline to approximately 6 years
Title
Serum Concentration of Obinutuzumab
Time Frame
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
Title
Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline
Time Frame
Baseline
Title
Percentage of Participants with ADAs During the Study
Time Frame
Up to approximately 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: CA42750 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group; Llc, Central
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Alabama; Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Individual Site Status
Recruiting
Facility Name
Unity Health - White County Medical Center- Rheumatology
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Rheumatology Clinical Trials Incorporated
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Denver, Barbara Davis Center, Center For Clinical Research
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis & Rheumatism; Disease Specialities
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
: Reliant Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Withdrawn
Facility Name
Adventhealth Medical Group ? Tampa ? IM/Rheumatology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Withdrawn
Facility Name
Arthritis & Rheumatology of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Withdrawn
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Center of Rheumatology
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute of Michigan, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Name
Suny Downstate Medical Center; Rheumatology
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Withdrawn
Facility Name
Northwell Health Division of Rheumatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center; Division of Rheumatology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Joint & Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
DJL Clinical Research PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Paramount Medical Research & Consulting, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Amarillo Center For Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Individual Site Status
Recruiting
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Prolato Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
DOM Centro de Reumatología
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1111AAJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Ser Servicos Especializados Em Reumatologia
City
Salvador
State/Province
BA
ZIP/Postal Code
40150-150
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - UFMG
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Mineiro de Pesquisa - CMIP
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010-570
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Centro de Estudos em Terapias Inovadoras ? CETI
City
Curtiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Revmatologicky Ustav
City
Prague
ZIP/Postal Code
128 50
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hopital La Cavale Blanche; Rhumatologie
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
CH de Bicêtre; Rhumatologie
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital de L'Archet; Medecine Interne
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Ch Pitie Salpetriere; Medecine Interne I
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Active, not recruiting
Facility Name
HOPITAL COCHIN; Internal Medicine Department
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Sud - CHU de Rennes Service interne
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Hautepierre; Rhumatologie
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna; Reumatologia
City
Cona (FE)
State/Province
Emilia-Romagna
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS S. Raffaele; U.O. Immunologia, Reumatologia, Allergologia e Malattie Rare
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Uni Di Padova; Divisione Di Rheumatologia
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
City
Mexicali
State/Province
BAJA California
ZIP/Postal Code
21100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigación y Tratamiento Reumatológico S.C.
City
Mexico, DF
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
11850
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
City
Culiacán Rosales
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Middlemore Hospital; Dept of Rheumatology
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Hogar Clínica San Juan de Dios
City
Arequipa
ZIP/Postal Code
04000
Country
Peru
Individual Site Status
Recruiting
Facility Name
Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB
City
Lima
ZIP/Postal Code
15431
Country
Peru
Individual Site Status
Recruiting
Facility Name
Instituto de Ginecología y Reproducción
City
Lima
Country
Peru
Individual Site Status
Active, not recruiting
Facility Name
Clinica El Golf
City
San Isidro
ZIP/Postal Code
L27 Lima
Country
Peru
Individual Site Status
Recruiting
Facility Name
Clinica Peruana Americana
City
Trujillo
ZIP/Postal Code
13011
Country
Peru
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Medyczne Centrum Hetmanska
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Individual Site Status
Recruiting
Facility Name
Prywatna Praktyka Lekarska; Prof.UM dr hab.med Pawel Hryc
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
City
Poznan
ZIP/Postal Code
61-545
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Recruiting
Facility Name
REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna
City
Wroc?aw
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
Republican clinical hospital named after G.G. Kuvatov
City
UFA
State/Province
Baskortostan
ZIP/Postal Code
450005
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital 9"
City
Yaroslavl
State/Province
Jaroslavl
ZIP/Postal Code
150042
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119021
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Ryazan State Medical University Named after I.P.Pavlov
City
Ryazan
State/Province
Rjazan
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health
City
Sankt-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Center of Family Medicine LC
City
Yekaterinburg
State/Province
Sankt Petersburg
ZIP/Postal Code
620043
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Scient Res Med Ctr Your Health
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420064
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
SBHI of Yaroslavl Region Clinical Hospital #3
City
Yaroslavl
State/Province
Volgograd
ZIP/Postal Code
150051
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Panorama Medical Center; Rheumatology
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
TREAD Research
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Winelands Medical Research; Medical Research
City
Cape Town
ZIP/Postal Code
7600
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Precise Clinical Solutions (Pty) Ltd
City
Chatsworth
ZIP/Postal Code
4092
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Metropolitan Clinical Research Institute
City
Polokwane
ZIP/Postal Code
0699
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Greenacres Hospital
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Mediclinic Vergelegen
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Netcare Umhlanga Medical Centre; Rheumatology
City
Umhlanga
ZIP/Postal Code
4319
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina Interna
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Meixoeiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36214
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Basurto; Servicio de Reumatologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial de Barcelona; Enfermedades Autoinmmunes
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Addenbrooke'S Hospital; Rheumatology Research Unit
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Aintree University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Free Hospital; Department of Rheumatology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Guy's Hospital; Louise Coote Lupus Unit
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Manchester Royal Infirmary; Kellgren Centre for Rheumatology
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust; Lancashire Clinical Research Facility
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

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