Clinical trial NCT01709578: To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
Official title: A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-10-18
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for:

* reduction of signs and symptoms at Week 24 and
* improvement of physical function at Week 12

in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists.

Secondary Objectives:

The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for:

* Reduction of signs and symptoms at Week 12;
* Improvement in physical function at Week 24;
* Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24;
* Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24.

To assess the exposure of sarilumab added to DMARD therapy in this population.

To assess the safety of sarilumab in this population.

Detailed description: Total study duration was up to 34 weeks: screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participant were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Eligibility criteria: Inclusion criteria:

Diagnosis of RA ≥6 months duration, according to the ACR /European League against Rheumatism (EULAR) 2010 RA Classification Criteria

ACR Class I-III functional status, based on 1991 revised criteria

Anti-TNF therapy failures, defined by the investigator as participants with an inadequate clinical response, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation:

* TNF-blockers included, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab

Moderate-to-severely active RA

Continuous treatment with one or a combination of DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at least 6 weeks prior to screening:

* Methotrexate - 6 to 25 mg/week orally or parenterally
* Leflunomide - 10 to 20 mg orally daily
* Sulfasalazine - 1000 to 3000 mg orally daily
* Hydroxychloroquine - 200 to 400 mg orally daily

Exclusion criteria:

Participants \<18 years of age or legal adult age

Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA

History of juvenile idiopathic arthritis or arthritis onset prior to age 16

Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.

Treatment with anti-TNF agents, as follows:

* Within 28 days prior to the baseline visit - etanercept
* Within 42 days prior to the baseline visit - infliximab, adalimumab, golimumab, certolizumab pegol

Treatment with previous RA-directed biologic agents with other than TNF antagonist mechanisms:

Within 28 days prior to the randomization (baseline) visit - anakinra Within 42 days prior to the randomization (baseline) visit - abatacept

Within 6 months prior to the randomization (baseline) visit - any cell depleting agents including but not limited to rituximab without a normal lymphocyte and cluster of differentiation (CD) 19+ lymphocyte count

Treatment with any DMARD other than those allowed per protocol and limited to the maximum specified dosage within 12 weeks prior to baseline

Treatment with prednisone \>10 mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit

Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline

Prior treatment with anti-interleukin (IL) -6 or IL-6 receptor antagonist therapies, including tocilizumab or sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm

Prior treatment with a Janus kinase inhibitor (such as tofacitinib)

New treatment or dose-adjustment to ongoing medication for dyslipidemia within 6 weeks prior to randomization, ie, stable dose for at least 6 weeks prior to randomization

Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever was longer

History of alcohol or drug abuse within 5 years prior to the screening visit

Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative disorders were also excluded

Participants with active tuberculosis or latent tuberculosis infection

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Primary outcomes:
measure: Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24
timeFrame: Week 24
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving ACR50 Criteria at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving ACR70 Criteria at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24
timeFrame: Week 24
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in HAQ-DI at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in SF-36 MCS at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Morning Stiffness VAS at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA
timeFrame: Baseline, Week 24
measure: Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity
timeFrame: Baseline, Week 24
measure: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12
timeFrame: Week 12
measure: Change From Baseline in DAS28-CRP at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Clinical Remission Score (DAS28--CRP <2.6) at Week 12
timeFrame: Week 12
measure: Change From Baseline in SF-36 at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA
timeFrame: Baseline, Week 12
measure: Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity
timeFrame: Baseline, Week 12
measure: Change From Baseline in the FACIT-fatigue at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in EQ-5D-3L VAS Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in RAID Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Investigational Site Number 840070
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site Number 840138
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site Number 840142
state: Arizona
city: Fullerton
country: United States
facility: Investigational Site Number 840134
state: California
city: Glendale
country: United States
facility: Investigational Site Number 840141
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840111
state: California
city: San Diego
country: United States
facility: Investigational Site Number 840135
state: California
city: Santa Maria
country: United States
facility: Investigational Site Number 840021
state: California
city: Stanford
country: United States
facility: Investigational Site Number 840100
state: California
city: Upland
country: United States
facility: Investigational Site Number 840049
state: California
city: Whittier
country: United States
facility: Investigational Site Number 840131
state: California
city: Denver
country: United States
facility: Investigational Site Number 840201
state: Colorado
city: Lewes
country: United States
facility: Investigational Site Number 840130
state: Delaware
city: DeBary
country: United States
facility: Investigational Site Number 840125
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840048
state: Florida
city: Naples
country: United States
facility: Investigational Site Number 840024
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840006
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site Number 840128
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840063
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840060
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840140
state: Florida
city: Vero Beach
country: United States
facility: Investigational Site Number 840126
state: Florida
city: Idaho Falls
country: United States
facility: Investigational Site Number 840018
state: Idaho
city: Meridian
country: United States
facility: Investigational Site Number 840110
state: Idaho
city: Kansas City
country: United States
facility: Investigational Site Number 840052
state: Kansas
city: Lexington
country: United States
facility: Investigational Site Number 840015
state: Kentucky
city: Baton Rouge
country: United States
facility: Investigational Site Number 840120
state: Louisiana
city: Lake Charles
country: United States
facility: Investigational Site Number 840109
state: Louisiana
city: Frederick
country: United States
facility: Investigational Site Number 840055
state: Maryland
city: Lansing
country: United States
facility: Investigational Site Number 840150
state: Michigan
city: Saint Clair Shores
country: United States
facility: Investigational Site Number 840137
state: Michigan
city: Tupelo
country: United States
facility: Investigational Site Number 840037
state: Mississippi
city: Lincoln
country: United States
facility: Investigational Site Number 840112
state: Nebraska
city: Orchard Park
country: United States
facility: Investigational Site Number 840106
state: New York
city: Rochester
country: United States
facility: Investigational Site Number 840121
state: New York
city: Roslyn
country: United States
facility: Investigational Site Number 840115
state: New York
city: Smithtown
country: United States
facility: Investigational Site Number 840118
state: New York
city: Syracuse
country: United States
facility: Investigational Site Number 840139
state: New York
city: Charlotte
country: United States
facility: Investigational Site Number 840123
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840116
state: North Carolina
city: Oklahoma City
country: United States
facility: Investigational Site Number 840127
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840011
state: Oklahoma
city: Duncansville
country: United States
facility: Investigational Site Number 840009
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840117
state: Pennsylvania
city: Reading
country: United States
facility: Investigational Site Number 840062
state: Pennsylvania
city: Columbia
country: United States
facility: Investigational Site Number 840058
state: South Carolina
city: Jackson
country: United States
facility: Investigational Site Number 840025
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site Number 840059
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840132
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840022
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840114
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840133
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840129
state: Texas
city: Mesquite
country: United States
facility: Investigational Site Number 840074
state: Texas
city: Spokane
country: United States
facility: Investigational Site Number 840036
state: Washington
city: Clarksburg
country: United States
facility: Investigational Site Number 840124
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032015
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032008
city: Caba
country: Argentina
facility: Investigational Site Number 032019
city: Caba
country: Argentina
facility: Investigational Site Number 032006
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032016
city: Cordoba
country: Argentina
facility: Investigational Site Number 032020
city: La Plata
country: Argentina
facility: Investigational Site Number 032017
city: Ramos Mejia
country: Argentina
facility: Investigational Site Number 032010
city: Rosario
country: Argentina
facility: Investigational Site Number 032013
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032004
city: Zarate
country: Argentina
facility: Investigational Site Number 032009
city: Victoria Park
country: Australia
facility: Investigational Site Number 036014
city: Stockerau
country: Austria
facility: Investigational Site Number 040004
city: Wien
country: Austria
facility: Investigational Site Number 040003
city: Curitiba
country: Brazil
facility: Investigational Site Number 076001
city: Curitiba
country: Brazil
facility: Investigational Site Number 076016
city: Goiania
country: Brazil
facility: Investigational Site Number 076006
city: Juiz De Fora
country: Brazil
facility: Investigational Site Number 076010
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076005
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076015
city: Toronto
country: Canada
facility: Investigational Site Number 124005
city: Trois-Rivières
country: Canada
facility: Investigational Site Number 124009
city: Victoria
country: Canada
facility: Investigational Site Number 124104
city: Temuco
country: Chile
facility: Investigational Site Number 152015
city: Bogota
country: Colombia
facility: Investigational Site Number 170001
city: Bogota
country: Colombia
facility: Investigational Site Number 170012
city: Bogotá
country: Colombia
facility: Investigational Site Number 170006
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170007
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170009
city: Chia
country: Colombia
facility: Investigational Site Number 170014
city: Medellin
country: Colombia
facility: Investigational Site Number 170019
city: Hostivice
country: Czechia
facility: Investigational Site Number 203008
city: Ostrava
country: Czechia
facility: Investigational Site Number 203004
city: Praha 2
country: Czechia
facility: Investigational Site Number 203007
city: Uherske Hradiste
country: Czechia
facility: Investigational Site Number 203002
city: Zlin
country: Czechia
facility: Investigational Site Number 203006
city: Cuenca
country: Ecuador
facility: Investigational Site Number 218003
city: Guayaquil
country: Ecuador
facility: Investigational Site Number 218001
city: Quito
country: Ecuador
facility: Investigational Site Number 218002
city: Bad Nauheim
country: Germany
facility: Investigational Site Number 276011
city: Berlin
country: Germany
facility: Investigational Site Number 276010
city: Berlin
country: Germany
facility: Investigational Site Number 276001
city: Berlin
country: Germany
facility: Investigational Site Number 276014
city: Deggingen
country: Germany
facility: Investigational Site Number 276018
city: Erlangen
country: Germany
facility: Investigational Site Number 276004
city: Halle/Saale
country: Germany
facility: Investigational Site Number 276015
city: Hamburg
country: Germany
facility: Investigational Site Number 276013
city: Leipzig
country: Germany
facility: Investigational Site Number 276016
city: München
country: Germany
facility: Investigational Site Number 276017
city: Osnabrück
country: Germany
facility: Investigational Site Number 276021
city: Tübingen
country: Germany
facility: Investigational Site Number 276020
city: Zerbst
country: Germany
facility: Investigational Site Number 276019
city: Heraklion
country: Greece
facility: Investigational Site Number 300002
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300005
city: Guatemala City
country: Guatemala
facility: Investigational Site Number 320002
city: Guatemala City
country: Guatemala
facility: Investigational Site Number 320003
city: Guatemala City
country: Guatemala
facility: Investigational Site Number 320001
city: Budapest
country: Hungary
facility: Investigational Site Number 348022
city: Debrecen
country: Hungary
facility: Investigational Site Number 348003
city: Veszprém
country: Hungary
facility: Investigational Site Number 348004
city: Veszprém
country: Hungary
facility: Investigational Site Number 348017
city: Haifa
country: Israel
facility: Investigational Site Number 376001
city: Petach Tikva
country: Israel
facility: Investigational Site Number 376003
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 376002
city: Catania
country: Italy
facility: Investigational Site Number 380011
city: Firenze
country: Italy
facility: Investigational Site Number 380002
city: Genova
country: Italy
facility: Investigational Site Number 380005
city: Milano
country: Italy
facility: Investigational Site Number 380014
city: Udine
country: Italy
facility: Investigational Site Number 380013
city: Daejeon
country: Korea, Republic of
facility: Investigational Site Number 410017
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410016
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440005
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440006
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440007
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484023
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484018
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484024
city: Mexicali
country: Mexico
facility: Investigational Site Number 484010
city: Monterrey
country: Mexico
facility: Investigational Site Number 484019
city: Monterrey
country: Mexico
facility: Investigational Site Number 484020
city: Monterrey
country: Mexico
facility: Investigational Site Number 484005
city: México
country: Mexico
facility: Investigational Site Number 484017
city: Queretaro
country: Mexico
facility: Investigational Site Number 484021
city: Hamilton
country: New Zealand
facility: Investigational Site Number 554005
city: Nelson
country: New Zealand
facility: Investigational Site Number 554011
city: Otahuhu
country: New Zealand
facility: Investigational Site Number 554007
city: Timaru
country: New Zealand
facility: Investigational Site Number 554001
city: Wellington
country: New Zealand
facility: Investigational Site Number 554006
city: Lima
country: Peru
facility: Investigational Site Number 604010
city: Lima
country: Peru
facility: Investigational Site Number 604009
city: Lima
country: Peru
facility: Investigational Site Number 604006
city: Lima
country: Peru
facility: Investigational Site Number 604012
city: Lima
country: Peru
facility: Investigational Site Number 604013
city: Lima
country: Peru
facility: Investigational Site Number 604001
city: Lima
country: Peru
facility: Investigational Site Number 604008
city: Lima
country: Peru
facility: Investigational Site Number 604007
city: Lima
country: Peru
facility: Investigational Site Number 604005
city: Lima
country: Peru
facility: Investigational Site Number 604014
city: Bialystok
country: Poland
facility: Investigational Site Number 616014
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 616019
city: Elblag
country: Poland
facility: Investigational Site Number 616015
city: Poznan
country: Poland
facility: Investigational Site Number 616018
city: Szczecin
country: Poland
facility: Investigational Site Number 616016
city: Warszawa
country: Poland
facility: Investigational Site Number 616004
city: Warszawa
country: Poland
facility: Investigational Site Number 616017
city: Wroclaw
country: Poland
facility: Investigational Site Number 616020
city: Lisboa
country: Portugal
facility: Investigational Site Number 620002
city: Lisboa
country: Portugal
facility: Investigational Site Number 620004
city: Ponte De Lima
country: Portugal
facility: Investigational Site Number 620007
city: Bucuresti
country: Romania
facility: Investigational Site Number 642001
city: Bucuresti
country: Romania
facility: Investigational Site Number 642012
city: Bucuresti
country: Romania
facility: Investigational Site Number 642002
city: Iasi
country: Romania
facility: Investigational Site Number 642014
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643021
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643022
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643008
city: Samara
country: Russian Federation
facility: Investigational Site Number 643010
city: Kosice
country: Slovakia
facility: Investigational Site Number 703001
city: Barakaldo
country: Spain
facility: Investigational Site Number 724016
city: Barcelona
country: Spain
facility: Investigational Site Number 724015
city: Cadiz
country: Spain
facility: Investigational Site Number 724014
city: La Coruña
country: Spain
facility: Investigational Site Number 724009
city: Málaga
country: Spain
facility: Investigational Site Number 724001
city: Sabadell
country: Spain
facility: Investigational Site Number 724011
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724017
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724013
city: Sevilla
country: Spain
facility: Investigational Site Number 724007
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 158005
city: Taipei
country: Taiwan
facility: Investigational Site Number 158006
city: Taoyuan County
country: Taiwan
facility: Investigational Site Number 158002
city: Edirne
country: Turkey
facility: Investigational Site Number 792007
city: Gaziantep
country: Turkey
facility: Investigational Site Number 792008
city: Samsun
country: Turkey
facility: Investigational Site Number 792009
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804013
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804014
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804027
city: Vinnytsia
country: Ukraine
facility: Investigational Site Number 804011
city: Zaporizhzhya
country: Ukraine
facility: Investigational Site Number 804009
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Fleischmann R, van Adelsberg J, Lin Y, Castelar-Pinheiro GD, Brzezicki J, Hrycaj P, Graham NM, van Hoogstraten H, Bauer D, Burmester GR. Sarilumab and Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2017 Feb;69(2):277-290. doi: 10.1002/art.39944.
citation: Rubbert-Roth A, Furst DE, Fiore S, Praestgaard A, Bykerk V, Bingham CO, Charles-Schoeman C, Burmester G. Association between low hemoglobin, clinical measures, and patient-reported outcomes in patients with rheumatoid arthritis: results from post hoc analyses of three phase III trials of sarilumab. Arthritis Res Ther. 2022 Aug 25;24(1):207. doi: 10.1186/s13075-022-02891-x.
citation: Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14.
citation: Fleischmann R, Genovese MC, Maslova K, Leher H, Praestgaard A, Burmester GR. Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. Rheumatology (Oxford). 2021 Nov 3;60(11):4991-5001. doi: 10.1093/rheumatology/keab355.
citation: Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, John GS, Gonzalez-Gay MA, Mandrup-Poulsen T, Fleischmann R. Interleukin-6 receptor blockade or TNFalpha inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020 Sep 9;22(1):206. doi: 10.1186/s13075-020-02229-5.
citation: Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z.
citation: Gossec L, Strand V, Proudfoot C, Chen CI, Guillonneau S, Kimura T, van Hoogstraten H, Mangan E, Reaney M. Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale. J Rheumatol. 2019 Oct;46(10):1259-1267. doi: 10.3899/jrheum.180904. Epub 2019 Mar 15.
citation: Gabay C, Msihid J, Zilberstein M, Paccard C, Lin Y, Graham NMH, Boyapati A. Identification of sarilumab pharmacodynamic and predictive markers in patients with inadequate response to TNF inhibition: a biomarker substudy of the phase 3 TARGET study. RMD Open. 2018 Mar 14;4(1):e000607. doi: 10.1136/rmdopen-2017-000607. eCollection 2018.
citation: Strand V, Reaney M, Chen CI, Proudfoot CW, Guillonneau S, Bauer D, Mangan E, Graham NM, van Hoogstraten H, Lin Y, Pacheco-Tena C, Fleischmann R. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors. RMD Open. 2017 Mar 7;3(1):e000416. doi: 10.1136/rmdopen-2016-000416. eCollection 2017.