AzTrials
AzTrials

Rheumatoid ArthritisPhase 3RA-COMPARENCT01764997

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

A Phase 3 study testing Sarilumab, Etanercept and Methotrexate in people with Rheumatoid Arthritis, run by Sanofi at 257 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Sarilumab, Etanercept and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
776 participants
Where
257 sitesin 31 countries
Study dates
Apr 2013to Jan 2015
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of RA >/= 3 months duration.
  • Continuous treatment of MTX 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.
  • Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.

Who cannot join

  • Age < 18 years.
  • Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.
  • Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.
  • Prior treatment with a tumor necrosis factor (TNF)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
  • New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors within 4 weeks of the screening visit.
  • Treatment with traditional oral DMARD /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.
  • 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

257 sites in 31 countries.

257 sites in 31 countries

United States30 sites

  • Investigational Site Number 840204

    Battle Creek, Michigan, 49015

  • Investigational Site Number 840004

    Birmingham, Alabama, 35205

  • Investigational Site Number 840124

    Clarksburg, West Virginia, 26301

  • Investigational Site Number 840210

    Clearwater, Florida, 33756

  • Investigational Site Number 840073

    Cumberland, Maryland, 21502

  • Investigational Site Number 840209

    Danbury, Connecticut, 06810

  • Investigational Site Number 840201

    Denver, Colorado, 80230

  • Investigational Site Number 840212

    Glendale, California, 91205

  • Investigational Site Number 840202

    Hagerstown, Maryland, 21740

  • Investigational Site Number 840018

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840213

    Indianapolis, Indiana, 46250

  • Investigational Site Number 840200

    Jackson, Mississippi, 39216

  • Investigational Site Number 840025

    Jackson, Tennessee, 38305

  • Investigational Site Number 840109

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 840150

    Lansing, Michigan, 48910

  • Investigational Site Number 840112

    Lincoln, Nebraska, 68516

  • Investigational Site Number 840074

    Mesquite, Texas, 75150

  • Investigational Site Number 840056

    New York, New York, 10016

  • Investigational Site Number 840016

    North Charleston, South Carolina, 29406

  • Investigational Site Number 840128

    Ormond Beach, Florida, 32174

  • Investigational Site Number 840063

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840117

    Pittsburgh, Pennsylvania, 15261

  • Investigational Site Number 840060

    Sarasota, Florida, 34239

  • Investigational Site Number 840061

    Tacoma, Washington, 98405

  • Investigational Site Number 840207

    Tampa, Florida, 33612

  • Investigational Site Number 840211

    Thousand Oaks, California, 91360

  • Investigational Site Number 840037

    Tupelo, Mississippi, 38801

  • Investigational Site Number 840049

    Upland, California, 91786

  • Investigational Site Number 840205

    Victorville, California, 92395

  • Investigational Site Number 840203

    Washington D.C., District of Columbia, 20003

Other trials in United States

Ukraine21 sites

  • Investigational Site Number 804003

    Dnipropetrovsk, 49008

  • Investigational Site Number 804002

    Donetsk, 83114

  • Investigational Site Number 804024

    Donetsk

  • Investigational Site Number 804029

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804010

    Kharkiv, 61022

  • Investigational Site Number 804001

    Kharkiv, 61057

  • Investigational Site Number 804025

    Kiev, 04114

  • Investigational Site Number 804023

    Kyiv, 01023

  • Investigational Site Number 804014

    Kyiv, 01103

  • Investigational Site Number 804027

    Kyiv, 03680

  • Investigational Site Number 804011

    Kyiv

  • Investigational Site Number 804030

    Lutsk, 43024

  • Investigational Site Number 804005

    Lviv, 79005

  • Investigational Site Number 804033

    Lviv, 79010

  • Investigational Site Number 804020

    Lviv, 79013

  • Investigational Site Number 804032

    Odesa, 65025

  • Investigational Site Number 804022

    Odesa, 65026

  • Investigational Site Number 804012

    Odesa, 65117

  • Investigational Site Number 804021

    Simferopol, 95017

  • Investigational Site Number 804028

    Zaporizhzhya, 69118

  • Investigational Site Number 804031

    Zhytomyr

Other trials in Ukraine

Poland16 sites

  • Investigational Site Number 616019

    Bydgoszcz, 85-168

  • Investigational Site Number 616054

    Bytom, 41-902

  • Investigational Site Number 616052

    Działdowo, 13-200

  • Investigational Site Number 616015

    Elblag

  • Investigational Site Number 616057

    Krakow, 31-121

  • Investigational Site Number 616059

    Krakow, 31-209

  • Investigational Site Number 616061

    Krakow

  • Investigational Site Number 616005

    Lublin, 20-607

  • Investigational Site Number 616063

    Myślenice, 32-400

  • Investigational Site Number 616018

    Poznan, 61-397

  • Investigational Site Number 616013

    Sosnowiec, 41-200

  • Investigational Site Number 616056

    Starachowice, 27-200

  • Investigational Site Number 616016

    Szczecin, 71-252

  • Investigational Site Number 616058

    Ustroń, 43-450

  • Investigational Site Number 616051

    Warsaw, 02-653

  • Investigational Site Number 616053

    Żyrardów, 96-300

Other trials in Poland

Russia16 sites

  • Investigational Site Number 643006

    Kemerovo, 650099

  • Investigational Site Number 643056

    Krasnoyarsk, 660022

  • Investigational Site Number 643052

    Moscow, 117556

  • Investigational Site Number 643021

    Moscow, 119049

  • Investigational Site Number 643031

    Moscow, 121374

  • Investigational Site Number 643030

    Moscow, 125284

  • Investigational Site Number 643022

    Novosibirsk, 630091

  • Investigational Site Number 643058

    Saint Peterburg

  • Investigational Site Number 643008

    Saint Petersburg, 192242

  • Investigational Site Number 643010

    Samara, 443095

  • Investigational Site Number 643011

    Saratov, 410012

  • Investigational Site Number 643059

    Smolensk, 214019

  • Investigational Site Number 643013

    Ufa, 450005

  • Investigational Site Number 643050

    Voronezh

  • Investigational Site Number 643057

    Yaroslavl, 150003

  • Investigational Site Number 643051

    Yaroslavl

Other trials in Russia

Mexico12 sites

  • Investigational Site Number 484023

    Chihuahua City, 31020

  • Investigational Site Number 484027

    Ciudad Obregón

  • Investigational Site Number 484029

    Deleg. Benito Juárez, 3100

  • Investigational Site Number 484013

    Guadalajara, 44158

  • Investigational Site Number 484018

    Guadalajara, 44620

  • Investigational Site Number 484004

    Mérida, 97000

  • Investigational Site Number 484010

    Mexicali, 21200

  • Investigational Site Number 484026

    Mexicali, 21200

  • Investigational Site Number 484017

    México, 06700

  • Investigational Site Number 484052

    Mexico City, 6726

  • Investigational Site Number 484025

    San Luis, 78220

  • Investigational Site Number 484051

    Tijuana, 22010

Other trials in Mexico

Romania12 sites

  • Investigational Site Number 642041

    Bacau

  • Investigational Site Number 642001

    Bucharest, 010976

  • Investigational Site Number 642040

    Bucharest, 020125

  • Investigational Site Number 642002

    Bucharest, 020983

  • Investigational Site Number 642012

    Bucharest, 400006

  • Investigational Site Number 642004

    Bucharest

  • Investigational Site Number 642023

    Bucharest

  • Investigational Site Number 642042

    Bucharest

  • Investigational Site Number 642005

    Galati, 800578

  • Investigational Site Number 642013

    Iași, 700127

  • Investigational Site Number 642014

    Iași, 700656

  • Investigational Site Number 642022

    Targoviste, 130083

Other trials in Romania

South Korea11 sites

  • Investigational Site Number 410020

    Busan, 602-715

  • Investigational Site Number 410006

    Busan, 602-739

  • Investigational Site Number 410013

    Daegu, 561-712

  • Investigational Site Number 410005

    Daejeon, 301-721

  • Investigational Site Number 410011

    Jeonju, 561-712

  • Investigational Site Number 410016

    Seoul, 120-752

  • Investigational Site Number 410015

    Seoul, 133-792

  • Investigational Site Number 410022

    Seoul, 135-710

  • Investigational Site Number 410023

    Seoul, 138-736

  • Investigational Site Number 410021

    Seoul, 158-710

  • Investigational Site Number 410008

    Suwon, 443-721

Other trials in South Korea

Germany10 sites

  • Investigational Site Number 276007

    Berlin, 12161

  • Investigational Site Number 276057

    Berlin, 12161

  • Investigational Site Number 276058

    Cologne

  • Investigational Site Number 276056

    Dresden, 01109

  • Investigational Site Number 276055

    Dresden, 01307

  • Investigational Site Number 276051

    Erlangen, 91056

  • Investigational Site Number 276013

    Hamburg, 22147

  • Investigational Site Number 276001

    Herne, 44649

  • Investigational Site Number 276053

    Ludwigsfelde, 14974

  • Investigational Site Number 276050

    Rostock

Other trials in Germany

Czechia8 sites

  • Investigational Site Number 203004

    Ostrava, 702 00

  • Investigational Site Number 203032

    Prague, 11000

  • Investigational Site Number 203001

    Prague, 12850

  • Investigational Site Number 203031

    Prague, 14059

  • Investigational Site Number 203033

    Prague, 14800

  • Investigational Site Number 203030

    Prague

  • Investigational Site Number 203002

    Uherské Hradiště, 686 01

  • Investigational Site Number 203006

    Zlín, 76001

Other trials in Czechia

France8 sites

  • Investigational Site Number 250003

    Amiens, 80054

  • Investigational Site Number 250007

    Bobigny

  • Investigational Site Number 250001

    La Roche-sur-Yon, 85925

  • Investigational Site Number 250002

    Montpellier, 34295

  • Investigational Site Number 250005

    Paris, 74014

  • Investigational Site Number 250004

    Paris, 75181

  • Investigational Site Number 250006

    Strasbourg

  • Investigational Site Number 250008

    Toulouse, 31000

Other trials in France

Israel8 sites

  • Investigational Site Number 376032

    Ashkelon, 78278

  • Investigational Site Number 376001

    Haifa, 31048

  • Investigational Site Number 376010

    Haifa, 31096

  • Investigational Site Number 376031

    Haifa, 34362

  • Investigational Site Number 376035

    Jerusalem, 91120

  • Investigational Site Number 376030

    Ramat Gan, 52621

  • Investigational Site Number 376011

    Tel Aviv, 64239

  • Investigational Site Number 376034

    Tel HaShomer, 52621

Other trials in Israel

Spain8 sites

  • Investigational Site Number 724009

    A Coruña, 15006

  • Investigational Site Number 724043

    Córdoba, 14004

  • Investigational Site Number 724042

    Madrid, 28034

  • Investigational Site Number 724041

    Madrid, 28046

  • Investigational Site Number 724040

    Madrid, 28850

  • Investigational Site Number 724001

    Málaga, 29009

  • Investigational Site Number 724011

    Sabadell, 08208

  • Investigational Site Number 724012

    Santiago de Compostela, 15705

Other trials in Spain

Argentina7 sites

  • Investigational Site Number 032052

    Buenos Aires, C1015ABO

  • Investigational Site Number 032050

    Buenos Aires, C1426AAL

  • Investigational Site Number 032053

    La Plata

  • Investigational Site Number 032013

    Rosario, S200PBJ

  • Investigational Site Number 032005

    San Miguel de Tucumán, 4000

  • Investigational Site Number 032051

    San Miguel de Tucumán

  • Investigational Site Number 032009

    Zárate, B2800DGH

Other trials in Argentina

Malaysia7 sites

  • Investigational Site Number 458012

    Batu Caves, 68100

  • Investigational Site Number 458014

    George Town, 10990

  • Investigational Site Number 458001

    Ipoh, 30990

  • Investigational Site Number 458013

    Kota Bharu, 15586

  • Investigational Site Number 458002

    Kuching, 93586

  • Investigational Site Number 458010

    Malacca, 75400

  • Investigational Site Number 458011

    Seremban, 70300

Other trials in Malaysia

Peru7 sites

  • Investigational Site Number 604001

    Lima, 021

  • Investigational Site Number 604010

    Lima, 14

  • Investigational Site Number 604009

    Lima, LIMA 01

  • Investigational Site Number 604012

    Lima, LIMA 11

  • Investigational Site Number 604007

    Lima, Lima 33

  • Investigational Site Number 604005

    Lima, LIMA 41

  • Investigational Site Number 604020

    Lima, Lima36

Other trials in Peru

United Kingdom7 sites

  • Investigational Site Number 826023

    Barnsley

  • Investigational Site Number 826022

    Birmingham, B15 2TH

  • Investigational Site Number 826021

    Dudley, DY1 2HQ

  • Investigational Site Number 826026

    Durham

  • Investigational Site Number 826027

    Durham

  • Investigational Site Number 826020

    Harlow, CM20 1QX

  • Investigational Site Number 826025

    Wigan, WN6 9EP

Other trials in United Kingdom

Brazil6 sites

  • Investigational Site Number 076001

    Curitiba, 80060-240

  • Investigational Site Number 076016

    Curitiba

  • Investigational Site Number 076006

    Goiânia, 74110-120

  • Investigational Site Number 076010

    Juiz de Fora, 36010-570

  • Investigational Site Number 076005

    Rio de Janeiro, 20551-030

  • Investigational Site Number 076013

    Vitória, 29055 450

Other trials in Brazil

Chile6 sites

  • Investigational Site Number 152005

    Osorno, 5311092

  • Investigational Site Number 152018

    Santiago, 7510047

  • Investigational Site Number 152001

    Santiago

  • Investigational Site Number 152002

    Santiago

  • Investigational Site Number 152011

    Santiago

  • Investigational Site Number 152015

    Temuco

Other trials in Chile

Colombia6 sites

  • Investigational Site Number 170016

    Bogotá, 0

  • Investigational Site Number 170040

    Bogotá, NAP

  • Investigational Site Number 170001

    Bogotá

  • Investigational Site Number 170007

    Bucaramanga

  • Investigational Site Number 170009

    Bucaramanga

  • Investigational Site Number 170041

    Medellín

Other trials in Colombia

Finland5 sites

  • Investigational Site Number 246001

    Helsinki, 00290

  • Investigational Site Number 246002

    Hyvinkää, 05800

  • Investigational Site Number 246030

    Oulu, 90100

  • Investigational Site Number 246003

    Pori, 28100

  • Investigational Site Number 246032

    Tampere

Other trials in Finland

Hungary5 sites

  • Investigational Site Number 348001

    Budapest, 1023

  • Investigational Site Number 348010

    Debrecen, 4031

  • Investigational Site Number 348021

    Esztergom, 2500

  • Investigational Site Number 348013

    Gy?r, 9025

  • Investigational Site Number 348008

    Gyula, 5700

Other trials in Hungary

Italy5 sites

  • Investigational Site Number 380002

    Florence, 50141

  • Investigational Site Number 380004

    Genova, 16011

  • Investigational Site Number 380005

    Genova, 16132

  • Investigational Site Number 380041

    L’Aquila, 67010

  • Investigational Site Number 380042

    Valeggio sul Mincio, 37064

Other trials in Italy

South Africa5 sites

  • Investigational Site Number 710011

    Cape Town, 7405

  • Investigational Site Number 710007

    Cape Town, 7500

  • Investigational Site Number 710008

    Pretoria, 0002

  • Investigational Site Number 710006

    Pretoria, 0182

  • Investigational Site Number 710010

    Stellenbsoch, 7600

Other trials in South Africa

Taiwan5 sites

  • Investigational Site Number 158010

    Changhua, 500

  • Investigational Site Number 158004

    Chiayi City, 622

  • Investigational Site Number 158012

    Kaohsiung City, 807

  • Investigational Site Number 158011

    Kaohsiung City, 833

  • Investigational Site Number 158006

    Taipei, 402

Other trials in Taiwan

Australia4 sites

  • Investigational Site Number 036020

    Camperdown, 2050

  • Investigational Site Number 036004

    Heidelberg West, 3081

  • Investigational Site Number 036014

    Victoria Park, 6100

  • Investigational Site Number 036007

    Woodville, 5011

Other trials in Australia

Greece4 sites

  • Investigational Site Number 300010

    Athens, 11527

  • Investigational Site Number 300002

    Heraklion, 71110

  • Investigational Site Number 300014

    N. Efkarpia, 56429

  • Investigational Site Number 300012

    Pátrai

Other trials in Greece

Lithuania4 sites

  • Investigational Site Number 440005

    Kaunas, LT-50009

  • Investigational Site Number 440006

    Klaipėda, LT-92288

  • Investigational Site Number 440010

    Panevezys, LT- 35144

  • Investigational Site Number 440011

    Vilnius, 08661

Other trials in Lithuania

New Zealand4 sites

  • Investigational Site Number 554007

    Auckland, 1023

  • Investigational Site Number 554010

    Dunedin, 9016

  • Investigational Site Number 554005

    Hamilton, 3204

  • Investigational Site Number 554011

    Nelson, 1023

Other trials in New Zealand

Thailand4 sites

  • Investigational Site Number 764002

    Bangkok, 10330

  • Investigational Site Number 764010

    Bangkok, 10400

  • Investigational Site Number 764003

    Bangkok Noi

  • Investigational Site Number 764011

    Khon Kaen, 40002

Other trials in Thailand

Ecuador3 sites

  • Investigational Site Number 218003

    Cuenca

  • Investigational Site Number 218001

    Guayaquil, 0593

  • Investigational Site Number 218002

    Quito, 0593

Other trials in Ecuador

Latvia3 sites

  • Investigational Site Number 428002

    Liepāja, LV-3401

  • Investigational Site Number 428001

    Riga, LV-1038

  • Investigational Site Number 428003

    Ventspils, LV 3601

Other trials in Latvia

About this study

Official title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

Read the detailed description

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks:

  • open label screening period of up to 4 weeks
  • open-label treatment period of 16 weeks
  • randomized screening period of 2 to 4 weeks
  • randomized treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks:

  • open label screening period of up to 4 weeks
  • open-label treatment period of 16 weeks
  • open label treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks:

  • open label screening period of up to 4 weeks
  • open-label treatment period of 16 weeks
  • screening period of 2 to 4 weeks
  • sarilumab treatment period of 52 weeks
  • sub-study post-treatment safety follow-up period of 6 weeks.
Being tested
Sarilumab, Etanercept, Methotrexate, Placebo (for sarilumab), Placebo (for etanercept)
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 in pre-filled syringe; Route of administration: Subcutaneous

  • EtanerceptDrug

    Also called Enbrel

    Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

  • MethotrexateDrug

    Dispensed according to local practice.

  • Placebo (for sarilumab)Drug

  • Placebo (for etanercept)Drug

  • AdalimumabDrug

    Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Study groups in NCT01764997
Study groupRoleWhat they receive
Adalimumab Open Label run-inExperimentalAdalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
Receives: Drug: Methotrexate; Drug: Adalimumab
Etanercept + MTX (Randomized)Active comparatorEtanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.
Receives: Drug: Etanercept; Drug: Methotrexate; Drug: Placebo (for sarilumab)
Sarilumab 150 mg + MTX (Randomized)ExperimentalSarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
Receives: Drug: Sarilumab; Drug: Methotrexate; Drug: Placebo (for etanercept)
Sarilumab 200 mg + MTX (Randomized)ExperimentalSarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
Receives: Drug: Sarilumab; Drug: Methotrexate; Drug: Placebo (for etanercept)
Sarilumab 150 mg + MTX Open Label Sub-studyExperimentalSarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
Receives: Drug: Sarilumab; Drug: Methotrexate

What is being measured

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

  1. Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24

    Measured: Baseline, Week 24

Secondary outcomes (3)

  1. Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24

    Measured: Week 12 and Week 24

  2. Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24

    Measured: Week 12 and Week 24

  3. Change From Baseline in DAS28-CRP Score at Week 12

    Measured: Baseline, Week 12

Timeline

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

  1. First posted10 Jan 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Due to small number of participants entering randomization. Not a safety issue.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764997
Sponsor's protocol ID
EFC11574
Other IDs
2012-001984-66, U1111-1131-6653
Acronym
RA-COMPARE
Status last verified
Jun 2017
First submitted
8 Jan 2013
Last updated
27 Jul 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sarilumab, Etanercept and Methotrexate in people with Rheumatoid Arthritis, run by Sanofi at 257 sites in 31 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 3 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: stopped early, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 257 sites in United States, Ukraine, Poland, Russia, Mexico and 26 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 27 Jul 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?

Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24 (time frame: Baseline, Week 24). 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 NCT01764997.

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 27 Jul 2017.

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