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

NCT01764997 | Terminated Phase 3 Results DMC

• 3 other identifiers: EFC115742012-001984-66U1111-1131-6653
• Study Type: interventional
• Target: 776
• Locations: 31 countries
• Sites: 257

Brief 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). 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 24

Secondary Outcomes (3)

• 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

  Week 12 and Week 24

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

  Week 12 and Week 24

• Change From Baseline in DAS28-CRP Score at Week 12

  Baseline, Week 12

Study Arms (5)

Adalimumab Open Label run-in

EXPERIMENTAL

Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.

Drug: Methotrexate; Drug: Adalimumab

Etanercept + MTX (Randomized)

ACTIVE COMPARATOR

Etanercept 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.

Drug: Etanercept; Drug: Methotrexate; Drug: Placebo (for sarilumab)

Sarilumab 150 mg + MTX (Randomized)

EXPERIMENTAL

Sarilumab 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.

Drug: Sarilumab; Drug: Methotrexate; Drug: Placebo (for etanercept)

Sarilumab 200 mg + MTX (Randomized)

EXPERIMENTAL

Sarilumab 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.

Drug: Sarilumab; Drug: Methotrexate; Drug: Placebo (for etanercept)

Sarilumab 150 mg + MTX Open Label Sub-study

EXPERIMENTAL

Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.

Drug: Sarilumab; Drug: Methotrexate

Interventions

Sarilumab DRUG

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

Also known as: SAR153191, REGN88

Sarilumab 150 mg + MTX (Randomized); Sarilumab 150 mg + MTX Open Label Sub-study; Sarilumab 200 mg + MTX (Randomized)

Etanercept DRUG

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

Also known as: Enbrel

Etanercept + MTX (Randomized)

Methotrexate DRUG

Dispensed according to local practice.

Adalimumab Open Label run-in; Etanercept + MTX (Randomized); Sarilumab 150 mg + MTX (Randomized); Sarilumab 150 mg + MTX Open Label Sub-study; Sarilumab 200 mg + MTX (Randomized)

Placebo (for sarilumab) DRUG

Etanercept + MTX (Randomized)

Placebo (for etanercept) DRUG

Sarilumab 150 mg + MTX (Randomized); Sarilumab 200 mg + MTX (Randomized)

Adalimumab DRUG

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

Adalimumab Open Label run-in

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (257)

Investigational Site Number 840004

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 840212

Glendale, California, 91205, United States

Location

Investigational Site Number 840211

Thousand Oaks, California, 91360, United States

Location

Investigational Site Number 840049

Upland, California, 91786, United States

Location

Investigational Site Number 840205

Victorville, California, 92395, United States

Location

Investigational Site Number 840201

Denver, Colorado, 80230, United States

Location

Investigational Site Number 840209

Danbury, Connecticut, 06810, United States

Location

Investigational Site Number 840203

Washington D.C., District of Columbia, 20003, United States

Location

Investigational Site Number 840210

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 840128

Ormond Beach, Florida, 32174, United States

Location

Investigational Site Number 840063

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840060

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 840207

Tampa, Florida, 33612, United States

Location

Investigational Site Number 840018

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site Number 840213

Indianapolis, Indiana, 46250, United States

Location

Investigational Site Number 840109

Lake Charles, Louisiana, 70601, United States

Location

Investigational Site Number 840073

Cumberland, Maryland, 21502, United States

Location

Investigational Site Number 840202

Hagerstown, Maryland, 21740, United States

Location

Investigational Site Number 840204

Battle Creek, Michigan, 49015, United States

Location

Investigational Site Number 840150

Lansing, Michigan, 48910, United States

Location

Investigational Site Number 840200

Jackson, Mississippi, 39216, United States

Location

Investigational Site Number 840037

Tupelo, Mississippi, 38801, United States

Location

Investigational Site Number 840112

Lincoln, Nebraska, 68516, United States

Location

Investigational Site Number 840056

New York, New York, 10016, United States

Location

Investigational Site Number 840117

Pittsburgh, Pennsylvania, 15261, United States

Location

Investigational Site Number 840016

North Charleston, South Carolina, 29406, United States

Location

Investigational Site Number 840025

Jackson, Tennessee, 38305, United States

Location

Investigational Site Number 840074

Mesquite, Texas, 75150, United States

Location

Investigational Site Number 840061

Tacoma, Washington, 98405, United States

Location

Investigational Site Number 840124

Clarksburg, West Virginia, 26301, United States

Location

Investigational Site Number 032052

Buenos Aires, C1015ABO, Argentina

Location

Investigational Site Number 032050

Buenos Aires, C1426AAL, Argentina

Location

Investigational Site Number 032053

La Plata, Argentina

Location

Investigational Site Number 032013

Rosario, S200PBJ, Argentina

Location

Investigational Site Number 032005

San Miguel de Tucumán, 4000, Argentina

Location

Investigational Site Number 032051

San Miguel de Tucumán, Argentina

Location

Investigational Site Number 032009

Zárate, B2800DGH, Argentina

Location

Investigational Site Number 036020

Camperdown, 2050, Australia

Location

Investigational Site Number 036004

Heidelberg West, 3081, Australia

Location

Investigational Site Number 036014

Victoria Park, 6100, Australia

Location

Investigational Site Number 036007

Woodville, 5011, Australia

Location

Investigational Site Number 076001

Curitiba, 80060-240, Brazil

Location

Investigational Site Number 076016

Curitiba, Brazil

Location

Investigational Site Number 076006

Goiânia, 74110-120, Brazil

Location

Investigational Site Number 076010

Juiz de Fora, 36010-570, Brazil

Location

Investigational Site Number 076005

Rio de Janeiro, 20551-030, Brazil

Location

Investigational Site Number 076013

Vitória, 29055 450, Brazil

Location

Investigational Site Number 152005

Osorno, 5311092, Chile

Location

Investigational Site Number 152018

Santiago, 7510047, Chile

Location

Investigational Site Number 152001

Santiago, Chile

Location

Investigational Site Number 152002

Santiago, Chile

Location

Investigational Site Number 152011

Santiago, Chile

Location

Investigational Site Number 152015

Temuco, Chile

Location

Investigational Site Number 170016

Bogotá, 0, Colombia

Location

Investigational Site Number 170040

Bogotá, NAP, Colombia

Location

Investigational Site Number 170001

Bogotá, Colombia

Location

Investigational Site Number 170007

Bucaramanga, Colombia

Location

Investigational Site Number 170009

Bucaramanga, Colombia

Location

Investigational Site Number 170041

Medellín, Colombia

Location

Investigational Site Number 203004

Ostrava, 702 00, Czechia

Location

Investigational Site Number 203032

Prague, 11000, Czechia

Location

Investigational Site Number 203001

Prague, 12850, Czechia

Location

Investigational Site Number 203031

Prague, 14059, Czechia

Location

Investigational Site Number 203033

Prague, 14800, Czechia

Location

Investigational Site Number 203030

Prague, Czechia

Location

Investigational Site Number 203002

Uherské Hradiště, 686 01, Czechia

Location

Investigational Site Number 203006

Zlín, 76001, Czechia

Location

Investigational Site Number 218003

Cuenca, Ecuador

Location

Investigational Site Number 218001

Guayaquil, 0593, Ecuador

Location

Investigational Site Number 218002

Quito, 0593, Ecuador

Location

Investigational Site Number 246001

Helsinki, 00290, Finland

Location

Investigational Site Number 246002

Hyvinkää, 05800, Finland

Location

Investigational Site Number 246030

Oulu, 90100, Finland

Location

Investigational Site Number 246003

Pori, 28100, Finland

Location

Investigational Site Number 246032

Tampere, Finland

Location

Investigational Site Number 250003

Amiens, 80054, France

Location

Investigational Site Number 250007

Bobigny, France

Location

Investigational Site Number 250001

La Roche-sur-Yon, 85925, France

Location

Investigational Site Number 250002

Montpellier, 34295, France

Location

Investigational Site Number 250005

Paris, 74014, France

Location

Investigational Site Number 250004

Paris, 75181, France

Location

Investigational Site Number 250006

Strasbourg, France

Location

Investigational Site Number 250008

Toulouse, 31000, France

Location

Investigational Site Number 276007

Berlin, 12161, Germany

Location

Investigational Site Number 276057

Berlin, 12161, Germany

Location

Investigational Site Number 276058

Cologne, Germany

Location

Investigational Site Number 276056

Dresden, 01109, Germany

Location

Investigational Site Number 276055

Dresden, 01307, Germany

Location

Investigational Site Number 276051

Erlangen, 91056, Germany

Location

Investigational Site Number 276013

Hamburg, 22147, Germany

Location

Investigational Site Number 276001

Herne, 44649, Germany

Location

Investigational Site Number 276053

Ludwigsfelde, 14974, Germany

Location

Investigational Site Number 276050

Rostock, Germany

Location

Investigational Site Number 300010

Athens, 11527, Greece

Location

Investigational Site Number 300002

Heraklion, 71110, Greece

Location

Investigational Site Number 300014

N. Efkarpia, 56429, Greece

Location

Investigational Site Number 300012

Pátrai, Greece

Location

Investigational Site Number 348001

Budapest, 1023, Hungary

Location

Investigational Site Number 348010

Debrecen, 4031, Hungary

Location

Investigational Site Number 348021

Esztergom, 2500, Hungary

Location

Investigational Site Number 348013

Gy?r, 9025, Hungary

Location

Investigational Site Number 348008

Gyula, 5700, Hungary

Location

Investigational Site Number 376032

Ashkelon, 78278, Israel

Location

Investigational Site Number 376001

Haifa, 31048, Israel

Location

Investigational Site Number 376010

Haifa, 31096, Israel

Location

Investigational Site Number 376031

Haifa, 34362, Israel

Location

Investigational Site Number 376035

Jerusalem, 91120, Israel

Location

Investigational Site Number 376030

Ramat Gan, 52621, Israel

Location

Investigational Site Number 376011

Tel Aviv, 64239, Israel

Location

Investigational Site Number 376034

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 380002

Florence, 50141, Italy

Location

Investigational Site Number 380004

Genova, 16011, Italy

Location

Investigational Site Number 380005

Genova, 16132, Italy

Location

Investigational Site Number 380041

L’Aquila, 67010, Italy

Location

Investigational Site Number 380042

Valeggio sul Mincio, 37064, Italy

Location

Investigational Site Number 428002

Liepāja, LV-3401, Latvia

Location

Investigational Site Number 428001

Riga, LV-1038, Latvia

Location

Investigational Site Number 428003

Ventspils, LV 3601, Latvia

Location

Investigational Site Number 440005

Kaunas, LT-50009, Lithuania

Location

Investigational Site Number 440006

Klaipėda, LT-92288, Lithuania

Location

Investigational Site Number 440010

Panevezys, LT- 35144, Lithuania

Location

Investigational Site Number 440011

Vilnius, 08661, Lithuania

Location

Investigational Site Number 458012

Batu Caves, 68100, Malaysia

Location

Investigational Site Number 458014

George Town, 10990, Malaysia

Location

Investigational Site Number 458001

Ipoh, 30990, Malaysia

Location

Investigational Site Number 458013

Kota Bharu, 15586, Malaysia

Location

Investigational Site Number 458002

Kuching, 93586, Malaysia

Location

Investigational Site Number 458010

Malacca, 75400, Malaysia

Location

Investigational Site Number 458011

Seremban, 70300, Malaysia

Location

Investigational Site Number 484023

Chihuahua City, 31020, Mexico

Location

Investigational Site Number 484027

Ciudad Obregón, Mexico

Location

Investigational Site Number 484029

Deleg. Benito Juárez, 3100, Mexico

Location

Investigational Site Number 484013

Guadalajara, 44158, Mexico

Location

Investigational Site Number 484018

Guadalajara, 44620, Mexico

Location

Investigational Site Number 484010

Mexicali, 21200, Mexico

Location

Investigational Site Number 484026

Mexicali, 21200, Mexico

Location

Investigational Site Number 484052

Mexico City, 6726, Mexico

Location

Investigational Site Number 484004

Mérida, 97000, Mexico

Location

Investigational Site Number 484017

México, 06700, Mexico

Location

Investigational Site Number 484025

San Luis, 78220, Mexico

Location

Investigational Site Number 484051

Tijuana, 22010, Mexico

Location

Investigational Site Number 554007

Auckland, 1023, New Zealand

Location

Investigational Site Number 554010

Dunedin, 9016, New Zealand

Location

Investigational Site Number 554005

Hamilton, 3204, New Zealand

Location

Investigational Site Number 554011

Nelson, 1023, New Zealand

Location

Investigational Site Number 604001

Lima, 021, Peru

Location

Investigational Site Number 604010

Lima, 14, Peru

Location

Investigational Site Number 604009

Lima, LIMA 01, Peru

Location

Investigational Site Number 604012

Lima, LIMA 11, Peru

Location

Investigational Site Number 604007

Lima, Lima 33, Peru

Location

Investigational Site Number 604005

Lima, LIMA 41, Peru

Location

Investigational Site Number 604020

Lima, Lima36, Peru

Location

Investigational Site Number 616019

Bydgoszcz, 85-168, Poland

Location

Investigational Site Number 616054

Bytom, 41-902, Poland

Location

Investigational Site Number 616052

Działdowo, 13-200, Poland

Location

Investigational Site Number 616015

Elblag, Poland

Location

Investigational Site Number 616057

Krakow, 31-121, Poland

Location

Investigational Site Number 616059

Krakow, 31-209, Poland

Location

Investigational Site Number 616061

Krakow, Poland

Location

Investigational Site Number 616005

Lublin, 20-607, Poland

Location

Investigational Site Number 616063

Myślenice, 32-400, Poland

Location

Investigational Site Number 616018

Poznan, 61-397, Poland

Location

Investigational Site Number 616013

Sosnowiec, 41-200, Poland

Location

Investigational Site Number 616056

Starachowice, 27-200, Poland

Location

Investigational Site Number 616016

Szczecin, 71-252, Poland

Location

Investigational Site Number 616058

Ustroń, 43-450, Poland

Location

Investigational Site Number 616051

Warsaw, 02-653, Poland

Location

Investigational Site Number 616053

Żyrardów, 96-300, Poland

Location

Investigational Site Number 642041

Bacau, Romania

Location

Investigational Site Number 642001

Bucharest, 010976, Romania

Location

Investigational Site Number 642040

Bucharest, 020125, Romania

Location

Investigational Site Number 642002

Bucharest, 020983, Romania

Location

Investigational Site Number 642012

Bucharest, 400006, Romania

Location

Investigational Site Number 642004

Bucharest, Romania

Location

Investigational Site Number 642023

Bucharest, Romania

Location

Investigational Site Number 642042

Bucharest, Romania

Location

Investigational Site Number 642005

Galati, 800578, Romania

Location

Investigational Site Number 642013

Iași, 700127, Romania

Location

Investigational Site Number 642014

Iași, 700656, Romania

Location

Investigational Site Number 642022

Târgovişte, 130083, Romania

Location

Investigational Site Number 643006

Kemerovo, 650099, Russia

Location

Investigational Site Number 643056

Krasnoyarsk, 660022, Russia

Location

Investigational Site Number 643052

Moscow, 117556, Russia

Location

Investigational Site Number 643021

Moscow, 119049, Russia

Location

Investigational Site Number 643031

Moscow, 121374, Russia

Location

Investigational Site Number 643030

Moscow, 125284, Russia

Location

Investigational Site Number 643022

Novosibirsk, 630091, Russia

Location

Investigational Site Number 643058

Saint Peterburg, Russia

Location

Investigational Site Number 643008

Saint Petersburg, 192242, Russia

Location

Investigational Site Number 643010

Samara, 443095, Russia

Location

Investigational Site Number 643011

Saratov, 410012, Russia

Location

Investigational Site Number 643059

Smolensk, 214019, Russia

Location

Investigational Site Number 643013

Ufa, 450005, Russia

Location

Investigational Site Number 643050

Voronezh, Russia

Location

Investigational Site Number 643057

Yaroslavl, 150003, Russia

Location

Investigational Site Number 643051

Yaroslavl, Russia

Location

Investigational Site Number 710011

Cape Town, 7405, South Africa

Location

Investigational Site Number 710007

Cape Town, 7500, South Africa

Location

Investigational Site Number 710008

Pretoria, 0002, South Africa

Location

Investigational Site Number 710006

Pretoria, 0182, South Africa

Location

Investigational Site Number 710010

Stellenbsoch, 7600, South Africa

Location

Investigational Site Number 410020

Busan, 602-715, South Korea

Location

Investigational Site Number 410006

Busan, 602-739, South Korea

Location

Investigational Site Number 410013

Daegu, 561-712, South Korea

Location

Investigational Site Number 410005

Daejeon, 301-721, South Korea

Location

Investigational Site Number 410011

Jeonju, 561-712, South Korea

Location

Investigational Site Number 410016

Seoul, 120-752, South Korea

Location

Investigational Site Number 410015

Seoul, 133-792, South Korea

Location

Investigational Site Number 410022

Seoul, 135-710, South Korea

Location

Investigational Site Number 410023

Seoul, 138-736, South Korea

Location

Investigational Site Number 410021

Seoul, 158-710, South Korea

Location

Investigational Site Number 410008

Suwon, 443-721, South Korea

Location

Investigational Site Number 724009

A Coruña, 15006, Spain

Location

Investigational Site Number 724043

Córdoba, 14004, Spain

Location

Investigational Site Number 724042

Madrid, 28034, Spain

Location

Investigational Site Number 724041

Madrid, 28046, Spain

Location

Investigational Site Number 724040

Madrid, 28850, Spain

Location

Investigational Site Number 724001

Málaga, 29009, Spain

Location

Investigational Site Number 724011

Sabadell, 08208, Spain

Location

Investigational Site Number 724012

Santiago de Compostela, 15705, Spain

Location

Investigational Site Number 158010

Changhua, 500, Taiwan

Location

Investigational Site Number 158004

Chiayi City, 622, Taiwan

Location

Investigational Site Number 158012

Kaohsiung City, 807, Taiwan

Location

Investigational Site Number 158011

Kaohsiung City, 833, Taiwan

Location

Investigational Site Number 158006

Taipei, 402, Taiwan

Location

Investigational Site Number 764002

Bangkok, 10330, Thailand

Location

Investigational Site Number 764010

Bangkok, 10400, Thailand

Location

Investigational Site Number 764003

Bangkok Noi, Thailand

Location

Investigational Site Number 764011

Khon Kaen, 40002, Thailand

Location

Investigational Site Number 804003

Dnipropetrovsk, 49008, Ukraine

Location

Investigational Site Number 804002

Donetsk, 83114, Ukraine

Location

Investigational Site Number 804024

Donetsk, Ukraine

Location

Investigational Site Number 804029

Ivano-Frankivsk, 76018, Ukraine

Location

Investigational Site Number 804010

Kharkiv, 61022, Ukraine

Location

Investigational Site Number 804001

Kharkiv, 61057, Ukraine

Location

Investigational Site Number 804025

Kiev, 04114, Ukraine

Location

Investigational Site Number 804023

Kyiv, 01023, Ukraine

Location

Investigational Site Number 804014

Kyiv, 01103, Ukraine

Location

Investigational Site Number 804027

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804011

Kyiv, Ukraine

Location

Investigational Site Number 804030

Lutsk, 43024, Ukraine

Location

Investigational Site Number 804005

Lviv, 79005, Ukraine

Location

Investigational Site Number 804033

Lviv, 79010, Ukraine

Location

Investigational Site Number 804020

Lviv, 79013, Ukraine

Location

Investigational Site Number 804032

Odesa, 65025, Ukraine

Location

Investigational Site Number 804022

Odesa, 65026, Ukraine

Location

Investigational Site Number 804012

Odesa, 65117, Ukraine

Location

Investigational Site Number 804021

Simferopol, 95017, Ukraine

Location

Investigational Site Number 804028

Zaporizhzhya, 69118, Ukraine

Location

Investigational Site Number 804031

Zhytomyr, Ukraine

Location

Investigational Site Number 826023

Barnsley, United Kingdom

Location

Investigational Site Number 826022

Birmingham, B15 2TH, United Kingdom

Location

Investigational Site Number 826021

Dudley, DY1 2HQ, United Kingdom

Location

Investigational Site Number 826026

Durham, United Kingdom

Location

Investigational Site Number 826027

Durham, United Kingdom

Location

Investigational Site Number 826020

Harlow, CM20 1QX, United Kingdom

Location

Investigational Site Number 826025

Wigan, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab; Etanercept; Methotrexate; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies

Limitations and Caveats

The study was prematurely terminated due to small number of participants entering randomization.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

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: January 8, 2013
• First Posted: January 10, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-06

Locations

UA (21); BR (6); TH (4); KR (11); ZA (5); HU (5); CZ (8); ES (8); AR (7); LI (4); IL (8); MY (7); ME (12); GR (4); EC (3); US (30); DE (10); PE (7); RU (16); FR (8); GB (7); IT (5); AU (4); CO (6); LA (3); TW (5); FI (5); CL (6); PL (16); NZ (4); RO (12)