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)
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
3 other identifiers
interventional
546
29 countries
194
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Oct 2012
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
August 8, 2017
CompletedAugust 8, 2017
July 1, 2017
2.4 years
October 15, 2012
May 23, 2017
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24
ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant (C-reactive Protein levels \[CRP\]); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by (health assessment questionnaire disability index \[HAQ-DI\]). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR.
Week 24
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. Least-squares (LS) means and standard errors (SE) at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.
Baseline, Week 12
Secondary Outcomes (39)
Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24
Baseline, Week 24
Percentage of Participants Achieving ACR50 Criteria at Week 24
Week 24
Percentage of Participants Achieving ACR70 Criteria at Week 24
Week 24
Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24
Week 24
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
Baseline, Week 24
- +34 more secondary outcomes
Study Arms (3)
Placebo q2w
PLACEBO COMPARATORPlacebo matched to sarilumab once every 2 weeks (q2w) was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.
Sarilumab 150 mg q2w
EXPERIMENTALSarilumab 150 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.
Sarilumab 200 mg q2w
EXPERIMENTALSarilumab 200 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
Dispensed according to the local practice.
Dispensed according to the local practice.
Dispensed according to the local practice.
Dispensed according to the local practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (196)
Investigational Site Number 840070
Anniston, Alabama, 36207, United States
Investigational Site Number 840138
Birmingham, Alabama, 35205, United States
Investigational Site Number 840142
Phoenix, Arizona, 85037, United States
Investigational Site Number 840134
Fullerton, California, 92835, United States
Investigational Site Number 840141
Glendale, California, 85304, United States
Investigational Site Number 840111
La Jolla, California, 92037, United States
Investigational Site Number 840135
San Diego, California, 92120, United States
Investigational Site Number 840021
Santa Maria, California, 94354, United States
Investigational Site Number 840100
Stanford, California, 94305, United States
Investigational Site Number 840049
Upland, California, 91786, United States
Investigational Site Number 840131
Whittier, California, 90606, United States
Investigational Site Number 840201
Denver, Colorado, 80230, United States
Investigational Site Number 840130
Lewes, Delaware, 19958, United States
Investigational Site Number 840125
DeBary, Florida, 32713, United States
Investigational Site Number 840048
Miami, Florida, 33155, United States
Investigational Site Number 840024
Naples, Florida, 34102, United States
Investigational Site Number 840006
Orlando, Florida, 32806, United States
Investigational Site Number 840128
Ormond Beach, Florida, 32174, United States
Investigational Site Number 840063
Palm Harbor, Florida, 34684, United States
Investigational Site Number 840060
Sarasota, Florida, 34239, United States
Investigational Site Number 840140
Tampa, Florida, 33614, United States
Investigational Site Number 840126
Vero Beach, Florida, 32960, United States
Investigational Site Number 840018
Idaho Falls, Idaho, 83404, United States
Investigational Site Number 840110
Meridian, Idaho, 83642, United States
Investigational Site Number 840052
Kansas City, Kansas, 66160-7321, United States
Investigational Site Number 840015
Lexington, Kentucky, 40504, United States
Investigational Site Number 840120
Baton Rouge, Louisiana, 70809, United States
Investigational Site Number 840109
Lake Charles, Louisiana, 70601, United States
Investigational Site Number 840055
Frederick, Maryland, 21702, United States
Investigational Site Number 840150
Lansing, Michigan, 48910, United States
Investigational Site Number 840137
Saint Clair Shores, Michigan, 48081, United States
Investigational Site Number 840037
Tupelo, Mississippi, 38801, United States
Investigational Site Number 840112
Lincoln, Nebraska, 68516, United States
Investigational Site Number 840106
Orchard Park, New York, 14127, United States
Investigational Site Number 840121
Rochester, New York, 14609, United States
Investigational Site Number 840115
Roslyn, New York, 11576, United States
Investigational Site Number 840118
Smithtown, New York, 11787, United States
Investigational Site Number 840139
Syracuse, New York, 13210, United States
Investigational Site Number 840123
Charlotte, North Carolina, 28210, United States
Investigational Site Number 840116
Wilmington, North Carolina, 28401, United States
Investigational Site Number 840127
Oklahoma City, Oklahoma, 73103, United States
Investigational Site Number 840011
Tulsa, Oklahoma, 74104, United States
Investigational Site Number 840009
Duncansville, Pennsylvania, 16635, United States
Investigational Site Number 840117
Pittsburgh, Pennsylvania, 15213, United States
Investigational Site Number 840062
Reading, Pennsylvania, 19611, United States
Investigational Site Number 840058
Columbia, South Carolina, 29204, United States
Investigational Site Number 840025
Jackson, Tennessee, 38305, United States
Investigational Site Number 840059
Memphis, Tennessee, 38119, United States
Investigational Site Number 840132
Austin, Texas, 78731, United States
Investigational Site Number 840022
Dallas, Texas, 75235, United States
Investigational Site Number 840114
El Paso, Texas, 79902, United States
Investigational Site Number 840133
Houston, Texas, 77008, United States
Investigational Site Number 840129
Houston, Texas, 77074, United States
Investigational Site Number 840074
Mesquite, Texas, 75150, United States
Investigational Site Number 840036
Spokane, Washington, 99204, United States
Investigational Site Number 840124
Clarksburg, West Virginia, 26301, United States
Investigational Site Number 032015
Buenos Aires, 32015, Argentina
Investigational Site Number 032008
Buenos Aires, C1428DZF, Argentina
Investigational Site Number 032019
Caba, 1180, Argentina
Investigational Site Number 032006
Caba, C1015ABO, Argentina
Investigational Site Number 032016
Capital Federal, 1425, Argentina
Investigational Site Number 032020
Córdoba, X5119XAA, Argentina
Investigational Site Number 032017
La Plata, Argentina
Investigational Site Number 032010
Ramos Mejía, B1704ETD, Argentina
Investigational Site Number 032013
Rosario, S2000PBJ, Argentina
Investigational Site Number 032004
San Miguel de Tucumán, T4000AXL, Argentina
Investigational Site Number 032009
Zárate, B2800DGH, Argentina
Investigational Site Number 036014
Victoria Park, 6100, Australia
Investigational Site Number 040004
Stockerau, 2000, Austria
Investigational Site Number 040003
Vienna, 1090, Austria
Investigational Site Number 076001
Curitiba, 80060-240, Brazil
Investigational Site Number 076016
Curitiba, Brazil
Investigational Site Number 076006
Goiânia, 74110-120, Brazil
Investigational Site Number 076010
Juiz de Fora, 36010-570, Brazil
Investigational Site Number 076005
Rio de Janeiro, 20551-030, Brazil
Investigational Site Number 076015
Rio de Janeiro, 22271-100, Brazil
Investigational Site Number 124005
Toronto, M5T 2S8, Canada
Investigational Site Number 124009
Trois-Rivières, G8Z 1Y2, Canada
Investigational Site Number 124104
Victoria, V8V 3P9, Canada
Investigational Site Number 152015
Temuco, Chile
Investigational Site Number 170001
Bogotá, Colombia
Investigational Site Number 170006
Bogotá, Colombia
Investigational Site Number 170012
Bogotá, Colombia
Investigational Site Number 170007
Bucaramanga, Colombia
Investigational Site Number 170009
Bucaramanga, Colombia
Investigational Site Number 170014
Chía, Colombia
Investigational Site Number 170019
Medellín, Colombia
Investigational Site Number 203008
Hostivice, 233 01, Czechia
Investigational Site Number 203004
Ostrava, 702 00, Czechia
Investigational Site Number 203007
Prague, 12850, Czechia
Investigational Site Number 203002
Uherské Hradiště, 686 01, Czechia
Investigational Site Number 203006
Zlín, 76001, Czechia
Investigational Site Number 218003
Cuenca, Ecuador
Investigational Site Number 218001
Guayaquil, 0593, Ecuador
Investigational Site Number 218002
Quito, 0593, Ecuador
Investigational Site Number 276011
Bad Nauheim, 61231, Germany
Investigational Site Number 276010
Berlin, 10117, Germany
Investigational Site Number 276001
Berlin, 12305, Germany
Investigational Site Number 276014
Berlin, 14059, Germany
Investigational Site Number 276018
Deggingen, 73326, Germany
Investigational Site Number 276004
Erlangen, 91054, Germany
Investigational Site Number 276015
Halle, 06108, Germany
Investigational Site Number 276013
Hamburg, 22147, Germany
Investigational Site Number 276016
Leipzig, 04103, Germany
Investigational Site Number 276017
München, 80336, Germany
Investigational Site Number 276021
Osnabrück, 49074, Germany
Investigational Site Number 276020
Tübingen, 72076, Germany
Investigational Site Number 276019
Zerbst, 39261, Germany
Investigational Site Number 300002
Heraklion, 71110, Greece
Investigational Site Number 300005
Thessaloniki, 57010, Greece
Investigational Site Number 320002
Guatemala City, 01009, Guatemala
Investigational Site Number 320003
Guatemala City, 01011, Guatemala
Investigational Site Number 320001
Guatemala City, 09090, Guatemala
Investigational Site Number 348022
Budapest, 1036, Hungary
Investigational Site Number 348003
Debrecen, 4032, Hungary
Investigational Site Number 348004
Veszprém, 8200, Hungary
Investigational Site Number 348017
Veszprém, 8200, Hungary
Investigational Site Number 376001
Haifa, 31048, Israel
Investigational Site Number 376003
Petah Tikva, 49100, Israel
Investigational Site Number 376002
Tel Litwinsky, 52621, Israel
Investigational Site Number 380011
Catania, 95122, Italy
Investigational Site Number 380002
Florence, 50139, Italy
Investigational Site Number 380005
Genova, 16132, Italy
Investigational Site Number 380014
Milan, 20157, Italy
Investigational Site Number 380013
Udine, 33100, Italy
Investigational Site Number 440005
Kaunas, LT-50009, Lithuania
Investigational Site Number 440006
Klaipėda, LT-92288, Lithuania
Investigational Site Number 440007
Vilnius, LT-08661, Lithuania
Investigational Site Number 484023
Chihuahua City, 31020, Mexico
Investigational Site Number 484018
Guadalajara, 44620, Mexico
Investigational Site Number 484002
Guadalajara, 44690, Mexico
Investigational Site Number 484024
Guadalajara, Mexico
Investigational Site Number 484010
Mexicali, 21200, Mexico
Investigational Site Number 484017
México, 06700, Mexico
Investigational Site Number 484019
Monterrey, 64000, Mexico
Investigational Site Number 484020
Monterrey, 64000, Mexico
Investigational Site Number 484005
Monterrey, 64460, Mexico
Investigational Site Number 484021
Querétaro, 76178, Mexico
Investigational Site Number 554005
Hamilton, 3204, New Zealand
Investigational Site Number 554011
Nelson, 7010, New Zealand
Investigational Site Number 554007
Otahuhu, 2025, New Zealand
Investigational Site Number 554001
Timaru, 7910, New Zealand
Investigational Site Number 554006
Wellington, 6021, New Zealand
Investigational Site Number 604010
Lima, 14, Peru
Investigational Site Number 604009
Lima, LIMA 01, Peru
Investigational Site Number 604006
Lima, LIMA 11, Peru
Investigational Site Number 604012
Lima, LIMA 11, Peru
Investigational Site Number 604013
Lima, LIMA 13, Peru
Investigational Site Number 604001
Lima, Lima 21, Peru
Investigational Site Number 604008
Lima, LIMA 27, Peru
Investigational Site Number 604007
Lima, Lima 33, Peru
Investigational Site Number 604005
Lima, LIMA 41, Peru
Investigational Site Number 604014
Lima, LIMA 41, Peru
Investigational Site Number 616014
Bialystok, 15-099, Poland
Investigational Site Number 616019
Bydgoszcz, 85-168, Poland
Investigational Site Number 616015
Elblag, 82-300, Poland
Investigational Site Number 616018
Poznan, 61-397, Poland
Investigational Site Number 616016
Szczecin, 71-252, Poland
Investigational Site Number 616004
Warsaw, 02-118, Poland
Investigational Site Number 616017
Warsaw, 02-653, Poland
Investigational Site Number 616020
Wroclaw, 50-556, Poland
Investigational Site Number 620002
Lisbon, 1050-034, Portugal
Investigational Site Number 620004
Lisbon, 1649-035, Portugal
Investigational Site Number 620007
Ponte de Lima, Portugal
Investigational Site Number 642001
Bucharest, 010976, Romania
Investigational Site Number 642012
Bucharest, 020475, Romania
Investigational Site Number 642002
Bucharest, 020983, Romania
Investigational Site Number 642014
Iași, 700661, Romania
Investigational Site Number 643001
Moscow, 115522, Russia
Investigational Site Number 643021
Moscow, 119049, Russia
Investigational Site Number 643022
Novosibirsk, 630091, Russia
Investigational Site Number 643008
Saint Petersburg, 192242, Russia
Investigational Site Number 643010
Samara, 443095, Russia
Investigational Site Number 703001
Košice, 040 11, Slovakia
Investigational Site Number 410017
Daejeon, 301-721, South Korea
Investigational Site Number 410016
Seoul, 120-752, South Korea
Investigational Site Number 724009
A Coruña, 15006, Spain
Investigational Site Number 724016
Barakaldo, 48903, Spain
Investigational Site Number 724015
Barcelona, 08034, Spain
Investigational Site Number 724014
Cadiz, 1009, Spain
Investigational Site Number 724001
Málaga, 29009, Spain
Investigational Site Number 724011
Sabadell, 08208, Spain
Investigational Site Number 724017
Santiago de Compostela, 15702, Spain
Investigational Site Number 724013
Santiago de Compostela, 15706, Spain
Investigational Site Number 724007
Seville, 41071, Spain
Investigational Site Number 158005
Kaohsiung City, 81346, Taiwan
Investigational Site Number 158006
Taipei, 402, Taiwan
Investigational Site Number 158002
Taoyuan, 33305, Taiwan
Investigational Site Number 792007
Edirne, 22030, Turkey (Türkiye)
Investigational Site Number 792008
Gaziantep, 27310, Turkey (Türkiye)
Investigational Site Number 792009
Samsun, Turkey (Türkiye)
Investigational Site Number 804013
Kharkiv, 61176, Ukraine
Investigational Site Number 804014
Kyiv, 01103, Ukraine
Investigational Site Number 804027
Kyiv, 03680, Ukraine
Investigational Site Number 804011
Vinnytsia, 21018, Ukraine
Investigational Site Number 804009
Zaporizhzhya, 69600, Ukraine
Related Publications (10)
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.
PMID: 27860410RESULTChoy E, Bykerk V, Lee YC, van Hoogstraten H, Ford K, Praestgaard A, Perrot S, Pope J, Sebba A. Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab. Rheumatology (Oxford). 2023 Jul 5;62(7):2386-2393. doi: 10.1093/rheumatology/keac659.
PMID: 36413080DERIVEDRubbert-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.
PMID: 36008838DERIVEDRehberg 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.
PMID: 34519964DERIVEDFleischmann 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.
PMID: 33871596DERIVEDGenovese 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.
PMID: 32907617DERIVEDGenovese 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.
PMID: 32522251DERIVEDGossec 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.
PMID: 30877216DERIVEDGabay 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.
PMID: 29556418DERIVEDStrand 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.
PMID: 28326189DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 18, 2012
Study Start
October 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 8, 2017
Results First Posted
August 8, 2017
Record last verified: 2017-07