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Rheumatoid ArthritisPhase 2/3RA-MOBILITYNCT01061736

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

A Phase 2/3 study testing Sarilumab, Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by Sanofi at 262 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Sarilumab, Methotrexate and Folic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,675 participants
Where
262 sitesin 36 countries
Study dates
Mar 2010to Oct 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of rheumatoid arthritis ≥3 months duration
  • Active disease defined as:
  • at least 8/68 tender joints and 6/66 swollen joints,
  • high sensitivity C-reactive protein (hs-CRP) >6 mg/l,
  • continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.
  • Part B only:
Show all 9Show fewer
  • Bone erosion based on documented X-ray prior to first study drug intake, or
  • Cyclic Citrullinated Peptide (CCP) positive, or
  • Rheumatoid Factor (RF) positive.

Who cannot join

  • Age <18 years or >75 years.
  • Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
  • Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
  • Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
  • Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
  • Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

262 sites in 36 countries.

262 sites in 36 countries

United States45 sites

  • Investigational Site Number 840070

    Anniston, Alabama, 36207

  • Investigational Site Number 840003

    Atlanta, Georgia, 30322

  • Investigational Site Number 840010

    Bethlehem, Pennsylvania, 18015

  • Investigational Site Number 840029

    Beverly Hills, California, 90211

  • Investigational Site Number 840004

    Birmingham, Alabama, 35205

  • Investigational Site Number 840046

    Chicago, Illinois, 60612

  • Investigational Site Number 840058

    Columbia, South Carolina, 29204

  • Investigational Site Number 840073

    Cumberland, Maryland, 21502

  • Investigational Site Number 840001

    Dallas, Texas, 75231

  • Investigational Site Number 840022

    Dallas, Texas, 75235

  • Investigational Site Number 840012

    Dallas, Texas, 75390

  • Investigational Site Number 840028

    Decatur, Georgia, 30033

  • Investigational Site Number 840009

    Duncansville, Pennsylvania, 16635

  • Investigational Site Number 840050

    Dunedin, Florida, 34698

  • Investigational Site Number 840055

    Frederick, Maryland, 21702

  • Investigational Site Number 840072

    Gilbert, Arizona, 85234

  • Investigational Site Number 840068

    Hickory, North Carolina, 28601

  • Investigational Site Number 840020

    Houston, Texas, 77034

  • Investigational Site Number 840018

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840025

    Jackson, Tennessee, 38305

  • Investigational Site Number 840041

    Jacksonville, Florida, 32209

  • Investigational Site Number 840067

    Jupiter, Florida, 33458

  • Investigational Site Number 840015

    Lexington, Kentucky, 40504

  • Investigational Site Number 840069

    Lubbock, Texas, 79424

  • Investigational Site Number 840027

    Marietta, Georgia, 30060

  • Investigational Site Number 840074

    Mesquite, Texas, 75150

  • Investigational Site Number 840048

    Miami, Florida, 33155

  • Investigational Site Number 840056

    New York, New York, 10016

  • Investigational Site Number 840016

    North Charleston, South Carolina, 29406

  • Investigational Site Number 840002

    Oklahoma City, Oklahoma, 73103

  • Investigational Site Number 840071

    Omaha, Nebraska, 68114

  • Investigational Site Number 840006

    Orlando, Florida, 32806

  • Investigational Site Number 840007

    Palm Desert, California, 92260

  • Investigational Site Number 840063

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840062

    Reading, Pennsylvania, 19611

  • Investigational Site Number 840008

    San Francisco, California, 94143

  • Investigational Site Number 840021

    Santa Maria, California, 94354

  • Investigational Site Number 840060

    Sarasota, Florida, 34239

  • Investigational Site Number 840066

    St Louis, Missouri, 63117

  • Investigational Site Number 840061

    Tacoma, Washington, 98405

  • Investigational Site Number 840044

    Toledo, Ohio, 43606

  • Investigational Site Number 840011

    Tulsa, Oklahoma, 74104

  • Investigational Site Number 840065

    Tulsa, Oklahoma, 74135

  • Investigational Site Number 840049

    Upland, California, 91786

  • Investigational Site Number 840013

    Wheaton, Maryland, 20902

Other trials in United States

Russia15 sites

  • Investigational Site Number 643017

    Kemerovo, 650066

  • Investigational Site Number 643006

    Kemerovo, 650099

  • Investigational Site Number 643004

    Moscow, 107014

  • Investigational Site Number 643020

    Moscow, 115404

  • Investigational Site Number 643001

    Moscow, 115522

  • Investigational Site Number 643002

    Moscow, 117997

  • Investigational Site Number 643012

    Moscow, 121359

  • Investigational Site Number 643009

    Novosibirsk, 630099

  • Investigational Site Number 643016

    Ryazan, 390026

  • Investigational Site Number 643007

    Saint Petersburg, 190068

  • Investigational Site Number 643008

    Saint Petersburg, 192242

  • Investigational Site Number 643014

    Saint Petersburg, 196247

  • Investigational Site Number 643010

    Samara, 443095

  • Investigational Site Number 643011

    Saratov, 410053

  • Investigational Site Number 643013

    Ufa, 450005

Other trials in Russia

South Korea14 sites

  • Investigational Site Number 410014

    Anyang, 431-070

  • Investigational Site Number 410006

    Busan, 602-739

  • Investigational Site Number 410004

    Daegu, 700-721

  • Investigational Site Number 410013

    Daegu, 705-718

  • Investigational Site Number 410005

    Daejeon, 302-799

  • Investigational Site Number 410010

    Gwangju, 501-757

  • Investigational Site Number 410009

    Incheon, 400-711

  • Investigational Site Number 410001

    Incheon

  • Investigational Site Number 410011

    Jeonju, 561-712

  • Investigational Site Number 410007

    Seoul, 110-744

  • Investigational Site Number 410012

    Seoul, 133-792

  • Investigational Site Number 410003

    Seoul, 150-713

  • Investigational Site Number 410002

    Seoul

  • Investigational Site Number 410008

    Suwon, 443-721

Other trials in South Korea

Chile13 sites

  • Investigational Site Number 152005

    Osorno

  • Investigational Site Number 152010

    Port Montt

  • Investigational Site Number 152012

    Santiago, 7500922

  • Investigational Site Number 152001

    Santiago

  • Investigational Site Number 152002

    Santiago

  • Investigational Site Number 152008

    Santiago

  • Investigational Site Number 152009

    Santiago

  • Investigational Site Number 152011

    Santiago

  • Investigational Site Number 152013

    Santiago

  • Investigational Site Number 152014

    Talca, 3460000

  • Investigational Site Number 152004

    Valdivia

  • Investigational Site Number 152007

    Viña del Mar, 2570017

  • Investigational Site Number 152006

    Viña del Mar

Other trials in Chile

Argentina12 sites

  • Investigational Site Number 032005

    Buenos Aires, 4000

  • Investigational Site Number 032007

    Buenos Aires

  • Investigational Site Number 032008

    Buenos Aires

  • Investigational Site Number 032006

    Caba, C1015ABO

  • Investigational Site Number 032002

    Córdoba, X5004BAL

  • Investigational Site Number 032003

    Córdoba

  • Investigational Site Number 032012

    Mar del Plata, B7600

  • Investigational Site Number 032011

    Quilmes, B1878DVB

  • Investigational Site Number 032010

    Ramos Mejía, 1704

  • Investigational Site Number 032001

    Rosario, 2000

  • Investigational Site Number 032004

    San Miguel de Tucumán, 4000

  • Investigational Site Number 032009

    Zárate, 2800

Other trials in Argentina

Australia12 sites

  • Investigational Site Number 036003

    Camperdown, 2050

  • Investigational Site Number 036005

    Clayton, 3168

  • Investigational Site Number 036012

    Fitzroy, 3065

  • Investigational Site Number 036010

    Garran, 2605

  • Investigational Site Number 036004

    Heidelberg West, 3081

  • Investigational Site Number 036009

    Herston, 4029

  • Investigational Site Number 036002

    Malvern East, 3145

  • Investigational Site Number 036001

    Maroochydore, 4558

  • Investigational Site Number 036006

    St Leonards, 2065

  • Investigational Site Number 036011

    Sydney, 2035

  • Investigational Site Number 036014

    Victoria Park, 6100

  • Investigational Site Number 036007

    Woodville, 5011

Other trials in Australia

India12 sites

  • Investigational Site Number 356015

    Ahmedabad, 380009

  • Investigational Site Number 356007

    Bangalore, 560079

  • Investigational Site Number 356003

    Chennai, 600004

  • Investigational Site Number 356012

    Hyderabad, 500003

  • Investigational Site Number 356005

    Hyderabad, 500004

  • Investigational Site Number 356011

    Lucknow, 226003

  • Investigational Site Number 356013

    Lucknow, 226014

  • Investigational Site Number 356001

    Maharashtra, 411 001

  • Investigational Site Number 356010

    Mumbai, 400008

  • Investigational Site Number 356004

    Mumbai, 400012

  • Investigational Site Number 356002

    New Delhi, 122001

  • Investigational Site Number 356008

    New Delhi, 76

Other trials in India

Brazil11 sites

  • Investigational Site Number 076008

    Campinas, 13015-001

  • Investigational Site Number 076012

    Campinas, 13083-970

  • Investigational Site Number 076001

    Curitiba, 80060-240

  • Investigational Site Number 076006

    Goiânia, 74110-120

  • Investigational Site Number 076010

    Juiz de Fora, 36010-570

  • Investigational Site Number 076004

    Porto Alegre, 90610-000

  • Investigational Site Number 076005

    Rio de Janeiro, 20551-030

  • Investigational Site Number 076011

    Salvador, 40050-410

  • Investigational Site Number 076002

    São Paulo, 04039-901

  • Investigational Site Number 076003

    São Paulo, 04230 000

  • Investigational Site Number 076013

    Vitória, 29055 450

Other trials in Brazil

South Africa11 sites

  • Investigational Site Number 710011

    Cape Town, 7405

  • Investigational Site Number 710007

    Cape Town, 7530

  • Investigational Site Number 710009

    Cape Town, 8001

  • Investigational Site Number 710003

    Durban, 4001

  • Investigational Site Number 710002

    Durban, 4091

  • Investigational Site Number 710001

    Johannesburg, 2013

  • Investigational Site Number 710004

    Kempton Park, 1619

  • Investigational Site Number 710005

    Pretoria, 0075

  • Investigational Site Number 710006

    Pretoria, 0182

  • Investigational Site Number 710008

    Pretoria

  • Investigational Site Number 710010

    Stellenbosch, 7600

Other trials in South Africa

Germany10 sites

  • Investigational Site Number 276007

    Berlin, 12161

  • Investigational Site Number 276008

    Berlin, 12161

  • Investigational Site Number 276004

    Erlangen, 91054

  • Investigational Site Number 276003

    Frankfurt am Main, 60590

  • Investigational Site Number 276015

    Halle, 06108

  • Investigational Site Number 276005

    Hamburg, 22081

  • Investigational Site Number 276013

    Hamburg, 22147

  • Investigational Site Number 276012

    Heidelberg, 69120

  • Investigational Site Number 276001

    Herne, 44652

  • Investigational Site Number 276006

    Hildesheim, 31134

Other trials in Germany

Hungary9 sites

  • Investigational Site Number 348006

    Budapest, 1023

  • Investigational Site Number 348014

    Budapest, 1027

  • Investigational Site Number 348003

    Debrecen, 4032

  • Investigational Site Number 348010

    Debrecen, 4043

  • Investigational Site Number 348011

    Eger, 3300

  • Investigational Site Number 348013

    Gy?r, 9025

  • Investigational Site Number 348005

    Sátoraljaújhely, 3980

  • Investigational Site Number 348015

    Szombathely, H-9700

  • Investigational Site Number 348004

    Veszprém, 8200

Other trials in Hungary

Colombia8 sites

  • Investigational Site Number 170004

    Barranquilla

  • Investigational Site Number 170001

    Bogotá

  • Investigational Site Number 170003

    Bogotá

  • Investigational Site Number 170006

    Bogotá

  • Investigational Site Number 170008

    Bogotá

  • Investigational Site Number 170007

    Bucaramanga

  • Investigational Site Number 170009

    Bucaramanga

  • Investigational Site Number 170002

    Medellín

Other trials in Colombia

Mexico8 sites

  • Investigational Site Number 484008

    Durango, 34270

  • Investigational Site Number 484002

    Guadalajara, 44690

  • Investigational Site Number 484004

    Mérida, 97000

  • Investigational Site Number 484009

    Mérida, 97000

  • Investigational Site Number 484007

    Metepec, 52140

  • Investigational Site Number 484001

    Mexico City, 11850

  • Investigational Site Number 484003

    Mexico City, 6726

  • Investigational Site Number 484005

    Monterrey, 64000

Other trials in Mexico

Romania8 sites

  • Investigational Site Number 642006

    Brăila, 810019

  • Investigational Site Number 642001

    Bucharest, 010976

  • Investigational Site Number 642002

    Bucharest, 020983

  • Investigational Site Number 642003

    Bucharest, 400347

  • Investigational Site Number 642004

    Bucharest

  • Investigational Site Number 642010

    Bucharest

  • Investigational Site Number 642005

    Galati, 800578

  • Investigational Site Number 642008

    Ploieşti

Other trials in Romania

Ukraine8 sites

  • Investigational Site Number 804003

    Dnipropetrovsk, 49008

  • Investigational Site Number 804002

    Donetsk, 83114

  • Investigational Site Number 804010

    Kharkiv, 61022

  • Investigational Site Number 804008

    Kyiv, 01023

  • Investigational Site Number 804004

    Kyiv, 03151

  • Investigational Site Number 804005

    Lviv, 79005

  • Investigational Site Number 804006

    Simferopol, 95017

  • Investigational Site Number 804009

    Zaporizhzhya, 69600

Other trials in Ukraine

Canada7 sites

  • Investigational Site Number 124004

    Burlington, L7R 1E2

  • Investigational Site Number 124003

    Mississauga, L5M 2V8

  • Investigational Site Number 124008

    Newmarket, L3Y 3R7

  • Investigational Site Number 124002

    St. Catharines, L2N 7E4

  • Investigational Site Number 124005

    Toronto, M5T 2S8

  • Investigational Site Number 124001

    Toronto, M9R 2Y8

  • Investigational Site Number 124012

    Winnipeg, R3A 1M3

Other trials in Canada

Poland7 sites

  • Investigational Site Number 616002

    Bialystok, 15-354

  • Investigational Site Number 616003

    Bialystok, 15-461

  • Investigational Site Number 616001

    Krakow, 30-510

  • Investigational Site Number 616005

    Lublin, 20-607

  • Investigational Site Number 616006

    Torun, 87-100

  • Investigational Site Number 616004

    Warsaw, 02-118

  • Investigational Site Number 616012

    Wroclaw, 50-044

Other trials in Poland

Spain5 sites

  • Investigational Site Number 724009

    A Coruña, 15006

  • Investigational Site Number 724010

    Barcelona, 08025

  • Investigational Site Number 724011

    Sabadell, 08208

  • Investigational Site Number 724012

    Santiago de Compostela, 15705

  • Investigational Site Number 724007

    Seville, 41008

Other trials in Spain

Turkey (Türkiye)5 sites

  • Investigational Site Number 792003

    Adana, 01330

  • Investigational Site Number 792002

    Ankara, 06100

  • Investigational Site Number 792005

    Ankara

  • Investigational Site Number 792004

    Antalya, 07059

  • Investigational Site Number 792001

    Izmir, 35340

Other trials in Turkey (Türkiye)

Czechia4 sites

  • Investigational Site Number 203005

    Brno, 63801

  • Investigational Site Number 203004

    Hlučín, 74801

  • Investigational Site Number 203001

    Prague, 12850

  • Investigational Site Number 203002

    Uherské Hradiště, 68601

Other trials in Czechia

New Zealand4 sites

  • Investigational Site Number 554004

    Christchurch, 8002

  • Investigational Site Number 554002

    Rotorua

  • Investigational Site Number 554003

    Tauranga, 3001

  • Investigational Site Number 554001

    Timaru

Other trials in New Zealand

Finland3 sites

  • Investigational Site Number 246001

    Helsinki, 00290

  • Investigational Site Number 246002

    Hyvinkää, 05800

  • Investigational Site Number 246003

    Pori, 28100

Other trials in Finland

Greece3 sites

  • Investigational Site Number 300001

    Athens, 11527

  • Investigational Site Number 300002

    Heraklion, 71110

  • Investigational Site Number 300003

    Thessaloniki, 546 36

Other trials in Greece

Malaysia3 sites

  • Investigational Site Number 458001

    Ipoh, 30990

  • Investigational Site Number 458002

    Kuching, 93586

  • Investigational Site Number 458003

    Putrajaya

Other trials in Malaysia

Philippines3 sites

  • Investigational Site Number 608003

    Cebu City, 6000

  • Investigational Site Number 608001

    Manila, 1008

  • Investigational Site Number 608002

    Manila

Other trials in Philippines

Portugal3 sites

  • Investigational Site Number 620003

    Aveiro, 3814-501

  • Investigational Site Number 620001

    Lisbon, 1649-035

  • Investigational Site Number 620002

    Lisbon

Other trials in Portugal

Austria2 sites

  • Investigational Site Number 040001

    Graz, 8036

  • Investigational Site Number 040002

    Vienna, 1100

Other trials in Austria

Belarus2 sites

  • Investigational Site Number 112002

    Minsk, 220037

  • Investigational Site Number 112001

    Minsk, 220116

Other trials in Belarus

Belgium2 sites

  • Investigational Site Number 056003

    Genk, 3600

  • Investigational Site Number 056001

    Liège, 4000

Other trials in Belgium

Egypt2 sites

  • Investigational Site Number 818001

    Cairo

  • Investigational Site Number 818002

    Cairo

Other trials in Egypt

Estonia2 sites

  • Investigational Site Number 233001

    Tallinn, 10128

  • Investigational Site Number 233002

    Tallinn, 13419

Other trials in Estonia

Lithuania2 sites

  • Investigational Site Number 440001

    Kaunas, LT-50009

  • Investigational Site Number 440002

    Vilnius, LT-08661

Other trials in Lithuania

Norway2 sites

  • Investigational Site Number 578004

    Kristiansand, 4604

  • Investigational Site Number 578006

    Tønsberg, 3105

Other trials in Norway

Taiwan2 sites

  • Investigational Site Number 158002

    Linkou District, 333

  • Investigational Site Number 158001

    Taipei, 100

Other trials in Taiwan

Thailand2 sites

  • Investigational Site Number 764001

    Bangkok, 10400

  • Investigational Site Number 764003

    Bangkok, 10700

Other trials in Thailand

Netherlands1 site

  • Investigational Site Number 528002

    Heerlen, 6419 PC

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Primary Objectives:

Part A (dose ranging study):

Read more

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

  • reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
  • inhibition of progression of structural damage at 52 weeks
  • improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

Read the detailed description

The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:

  • Screening: Up to 4 weeks
  • Treatment: 12 weeks (Part A) and 52 weeks (Part B)*
  • Follow-up: 6 weeks (for participants who would not continue in the long-term extension study).

'*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).

Being tested
Sarilumab, Placebo (for sarilumab), Methotrexate, Folic Acid
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SarilumabDrug

    Also called SAR153191, REGN88

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Placebo (for sarilumab)Drug

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • MethotrexateDrug

    Same weekly dose as received prior to enrollment

  • Folic AcidDrug

    According to local standard

Study groups in NCT01061736
Study groupRoleWhat they receive
Part A: SAR 100 mg qwExperimentalSarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.
Receives: Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid
Part A: SAR 150 mg qwExperimentalSarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
Receives: Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid
Part A: SAR 100 mg q2wExperimentalSarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
Receives: Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid
Part A: SAR 150 mg q2wExperimentalSarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
Receives: Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid
Part A: SAR 200 mg q2wExperimentalSarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
Receives: Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid
Part A: Placebo qwPlacebo comparatorPlacebo (for sarilumab) qw on top of MTX for 12 weeks.
Receives: Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid
Part B Cohort 1: Non-selected DosesExperimentalSarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
Receives: Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)ExperimentalSarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.
Receives: Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)ExperimentalSarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.
Receives: Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)ExperimentalPlacebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.
Receives: Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

    ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).

    Measured: Baseline to Week 12

  2. Part B: Percentage of Participants Achieving ACR20 Response at Week 24

    ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

    Measured: Baseline to Week 24

  3. Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16

    HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.

    Measured: Baseline, Week 16

  4. Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52

    The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.

    Measured: Baseline, Week 52

Secondary outcomes (1)

  1. Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52

    Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,675 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061736
Sponsor's protocol ID
EFC11072
Other IDs
2009-016266-90, 2009
Acronym
RA-MOBILITY
Status last verified
Jun 2017
First submitted
2 Feb 2010
Last updated
28 Jun 2017
Data monitoring committee
Yes

Publications

  • Strand V, Kosinski M, Chen CI, Joseph G, Rendas-Baum R, Graham NM, van Hoogstraten H, Bayliss M, Fan C, Huizinga T, Genovese MC. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016 Sep 6;18(1):198. doi: 10.1186/s13075-016-1096-9.

    PubMed 27600829

  • Huizinga TW, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, Huang X, Yancopoulos GD, Stahl N, Genovese MC. Sarilumab, a fully human monoclonal antibody against IL-6Ralpha in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014 Sep;73(9):1626-34. doi: 10.1136/annrheumdis-2013-204405. Epub 2013 Dec 2.

    PubMed 24297381

  • Genovese MC, Fleischmann R, Kivitz AJ, Rell-Bakalarska M, Martincova R, Fiore S, Rohane P, van Hoogstraten H, Garg A, Fan C, van Adelsberg J, Weinstein SP, Graham NM, Stahl N, Yancopoulos GD, Huizinga TW, van der Heijde D. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatol. 2015 Jun;67(6):1424-37. doi: 10.1002/art.39093.

    PubMed 25733246

  • Choy 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.

    PubMed 36413080

  • 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.

    PubMed 36008838

  • 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.

    PubMed 34519964

  • 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.

    PubMed 32907617

  • 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.

    PubMed 32522251

  • Boyapati A, Schwartzman S, Msihid J, Choy E, Genovese MC, Burmester GR, Lam G, Kimura T, Sadeh J, Weinreich DM, Yancopoulos GD, Graham NMH. Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis. Arthritis Rheumatol. 2020 Sep;72(9):1456-1466. doi: 10.1002/art.41299. Epub 2020 Aug 25.

    PubMed 32343882

  • Genovese MC, van der Heijde D, Lin Y, St John G, Wang S, van Hoogstraten H, Gomez-Reino JJ, Kivitz A, Maldonado-Cocco JA, Seriolo B, Stanislav M, Burmester GR. Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. RMD Open. 2019 Aug 1;5(2):e000887. doi: 10.1136/rmdopen-2018-000887. eCollection 2019.

    PubMed 31452928

  • Muszbek N, Proudfoot C, Fournier M, Chen CI, Kuznik A, Kiss Z, Gal P, Michaud K. Economic Evaluation of Sarilumab in the Treatment of Adult Patients with Moderately-to-Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs. Adv Ther. 2019 Jun;36(6):1337-1357. doi: 10.1007/s12325-019-00946-1. Epub 2019 Apr 19.

    PubMed 31004324

  • Boyapati A, Msihid J, Fiore S, van Adelsberg J, Graham NM, Hamilton JD. Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY. Arthritis Res Ther. 2016 Oct 6;18(1):225. doi: 10.1186/s13075-016-1132-9.

    PubMed 27716324

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sarilumab, Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by Sanofi at 262 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, Russia, South Korea, Chile, Argentina and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (time frame: Baseline to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061736, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.

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