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

Rheumatoid Arthritis Clinical Trial

— RA-COMPARE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01764997
• Other study ID #: EFC11574
• Secondary ID: 2012-001984-66U1
• Status: Terminated
• Phase: Phase 3
• First received: January 8, 2013
• Last updated: November 5, 2015
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Secondary Objectives:

To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX).

To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX).

To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).

Description:

The maximum study duration per patient enrolled in the Main study is 54 weeks broken down as follows:

• screening/run-in up to a maximum of 24 weeks

• treatment up to a maximum of 24 weeks

• follow-up of 6 weeks after treatment discontinuation.

The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as follows:

• treatment up to a maximum of 52 weeks

• follow-up of 6 weeks after treatment discontinuation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 452
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.

• Continuous treatment of methotrexate (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.

Exclusion criteria:

• 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 TNF (tumor necrosis factor)-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 inhibitors (COX-2 inhibitors within 4 weeks of the screening visit.

• Treatment with traditional oral disease-modifying antirheumatic drugs (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 patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
• Etanercept
Pharmaceutical form:solution Route of administration: subcutaneous
• Adalimumab
Pharmaceutical form:solution Route of administration: subcutaneous
• Methotrexate
Dispensed according to local practice.

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032050	Buenos Aires
Argentina	Investigational Site Number 032052	Buenos Aires
Argentina	Investigational Site Number 032053	La Plata
Argentina	Investigational Site Number 032013	Rosario
Argentina	Investigational Site Number 032051	San Miguel De Tucumán
Argentina	Investigational Site Number 032005	Tucuman
Argentina	Investigational Site Number 032009	Zarate
Australia	Investigational Site Number 036020	Camperdown
Australia	Investigational Site Number 036004	Heidelberg West
Australia	Investigational Site Number 036014	Victoria Park
Australia	Investigational Site Number 036007	Woodville
Brazil	Investigational Site Number 076001	Curitiba
Brazil	Investigational Site Number 076016	Curitiba
Brazil	Investigational Site Number 076006	Goiania
Brazil	Investigational Site Number 076010	Juiz De Fora
Brazil	Investigational Site Number 076005	Rio De Janeiro
Brazil	Investigational Site Number 076013	Vitoria
Chile	Investigational Site Number 152005	Osorno
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152002	Santiago
Chile	Investigational Site Number 152011	Santiago
Chile	Investigational Site Number 152018	Santiago
Chile	Investigational Site Number 152015	Temuco
Colombia	Investigational Site Number 170001	Bogota
Colombia	Investigational Site Number 170016	Bogota
Colombia	Investigational Site Number 170040	Bogotá
Colombia	Investigational Site Number 170007	Bucaramanga
Colombia	Investigational Site Number 170009	Bucaramanga
Colombia	Investigational Site Number 170041	Medellin
Czech Republic	Investigational Site Number 203004	Ostrava
Czech Republic	Investigational Site Number 203032	Praha
Czech Republic	Investigational Site Number 203001	Praha 2
Czech Republic	Investigational Site Number 203030	Praha 4
Czech Republic	Investigational Site Number 203031	Praha 4
Czech Republic	Investigational Site Number 203033	Praha 4
Czech Republic	Investigational Site Number 203002	Uherske Hradiste
Czech Republic	Investigational Site Number 203006	Zlin
Ecuador	Investigational Site Number 218003	Cuenca
Ecuador	Investigational Site Number 218001	Guayaquil
Ecuador	Investigational Site Number 218002	Quito
Finland	Investigational Site Number 246001	Helsinki
Finland	Investigational Site Number 246002	Hyvinkää
Finland	Investigational Site Number 246030	Oulu
Finland	Investigational Site Number 246003	Pori
Finland	Investigational Site Number 246032	Tampere
France	Investigational Site Number 250003	Amiens Cedex 1
France	Investigational Site Number 250007	Bobigny
France	Investigational Site Number 250001	La Roche Sur Yon Cedex 9
France	Investigational Site Number 250002	Montpellier
France	Investigational Site Number 250005	Paris
France	Investigational Site Number 250004	Paris Cedex 4
France	Investigational Site Number 250006	Strasbourg
France	Investigational Site Number 250008	Toulouse
Germany	Investigational Site Number 276007	Berlin
Germany	Investigational Site Number 276057	Berlin
Germany	Investigational Site Number 276055	Dresden
Germany	Investigational Site Number 276056	Dresden
Germany	Investigational Site Number 276051	Erlangen
Germany	Investigational Site Number 276013	Hamburg
Germany	Investigational Site Number 276001	Herne
Germany	Investigational Site Number 276058	Koeln
Germany	Investigational Site Number 276053	Ludwigsfelde
Germany	Investigational Site Number 276050	Rostock
Greece	Investigational Site Number 300010	Athens
Greece	Investigational Site Number 300002	Heraklion
Greece	Investigational Site Number 300014	N. Efkarpia
Greece	Investigational Site Number 300012	Patras
Hungary	Investigational Site Number 348001	Budapest
Hungary	Investigational Site Number 348010	Debrecen
Hungary	Investigational Site Number 348021	Esztergom
Hungary	Investigational Site Number 348013	Gy?r
Hungary	Investigational Site Number 348008	Gyula
Israel	Investigational Site Number 376032	Ashkelon
Israel	Investigational Site Number 376001	Haifa
Israel	Investigational Site Number 376010	Haifa
Israel	Investigational Site Number 376031	Haifa
Israel	Investigational Site Number 376035	Jerusalem
Israel	Investigational Site Number 376030	Ramat Gan
Israel	Investigational Site Number 376011	Tel Aviv
Israel	Investigational Site Number 376034	Tel Hashomer
Italy	Investigational Site Number 380002	Firenze
Italy	Investigational Site Number 380004	Genova
Italy	Investigational Site Number 380005	Genova
Italy	Investigational Site Number 380041	L'Aquila
Italy	Investigational Site Number 380042	Valeggio Sul Mincio
Korea, Republic of	Investigational Site Number 410006	Busan
Korea, Republic of	Investigational Site Number 410020	Busan
Korea, Republic of	Investigational Site Number 410013	Daegu
Korea, Republic of	Investigational Site Number 410005	Daejeon
Korea, Republic of	Investigational Site Number 410011	Jeonju
Korea, Republic of	Investigational Site Number 410015	Seoul
Korea, Republic of	Investigational Site Number 410016	Seoul
Korea, Republic of	Investigational Site Number 410021	Seoul
Korea, Republic of	Investigational Site Number 410022	Seoul
Korea, Republic of	Investigational Site Number 410023	Seoul
Korea, Republic of	Investigational Site Number 410008	Suwon
Latvia	Investigational Site Number 428002	Liepaja
Latvia	Investigational Site Number 428001	Riga
Latvia	Investigational Site Number 428003	Ventspils
Lithuania	Investigational Site Number 440005	Kaunas
Lithuania	Investigational Site Number 440006	Klaipeda
Lithuania	Investigational Site Number 440010	Panevezys
Lithuania	Investigational Site Number 440011	Vilnius
Malaysia	Investigational Site Number 458012	Batu Caves
Malaysia	Investigational Site Number 458014	Georgetown
Malaysia	Investigational Site Number 458001	Ipoh
Malaysia	Investigational Site Number 458013	Kota Bharu
Malaysia	Investigational Site Number 458002	Kuching
Malaysia	Investigational Site Number 458010	Melaka
Malaysia	Investigational Site Number 458011	Seremban
Mexico	Investigational Site Number 484027	Cd. Obregon
Mexico	Investigational Site Number 484023	Chihuahua
Mexico	Investigational Site Number 484029	Deleg. Benito Juárez
Mexico	Investigational Site Number 484013	Guadalajara
Mexico	Investigational Site Number 484018	Guadalajara
Mexico	Investigational Site Number 484004	Merida
Mexico	Investigational Site Number 484010	Mexicali
Mexico	Investigational Site Number 484026	Mexicali
Mexico	Investigational Site Number 484017	México
Mexico	Investigational Site Number 484052	Mexico City
Mexico	Investigational Site Number 484025	San Luis
Mexico	Investigational Site Number 484051	Tijuana
New Zealand	Investigational Site Number 554007	Auckland
New Zealand	Investigational Site Number 554010	Dunedin
New Zealand	Investigational Site Number 554005	Hamilton
New Zealand	Investigational Site Number 554011	Nelson
Peru	Investigational Site Number 604001	Lima
Peru	Investigational Site Number 604005	Lima
Peru	Investigational Site Number 604007	Lima
Peru	Investigational Site Number 604009	Lima
Peru	Investigational Site Number 604010	Lima
Peru	Investigational Site Number 604012	Lima
Peru	Investigational Site Number 604020	Lima
Poland	Investigational Site Number 616019	Bydgoszcz
Poland	Investigational Site Number 616054	Bytom
Poland	Investigational Site Number 616052	Dzialdowo
Poland	Investigational Site Number 616015	Elblag
Poland	Investigational Site Number 616057	Krakow
Poland	Investigational Site Number 616059	Krakow
Poland	Investigational Site Number 616061	Krakow
Poland	Investigational Site Number 616005	Lublin
Poland	Investigational Site Number 616063	Myslenice
Poland	Investigational Site Number 616018	Poznan
Poland	Investigational Site Number 616013	Sosnowiec
Poland	Investigational Site Number 616056	Starachowice
Poland	Investigational Site Number 616016	Szczecin
Poland	Investigational Site Number 616058	Ustron
Poland	Investigational Site Number 616051	Warszawa
Poland	Investigational Site Number 616053	Zyrardow
Romania	Investigational Site Number 642041	Bacau
Romania	Investigational Site Number 642004	Bucharest
Romania	Investigational Site Number 642012	Bucharest
Romania	Investigational Site Number 642023	Bucharest
Romania	Investigational Site Number 642001	Bucuresti
Romania	Investigational Site Number 642002	Bucuresti
Romania	Investigational Site Number 642040	Bucuresti
Romania	Investigational Site Number 642042	Bucuresti
Romania	Investigational Site Number 642005	Galati
Romania	Investigational Site Number 642013	Iasi
Romania	Investigational Site Number 642014	Iasi
Romania	Investigational Site Number 642022	Targoviste
Russian Federation	Investigational Site Number 643006	Kemerovo
Russian Federation	Investigational Site Number 643056	Krasnoyarsk
Russian Federation	Investigational Site Number 643021	Moscow
Russian Federation	Investigational Site Number 643030	Moscow
Russian Federation	Investigational Site Number 643031	Moscow
Russian Federation	Investigational Site Number 643052	Moscow
Russian Federation	Investigational Site Number 643022	Novosibirsk
Russian Federation	Investigational Site Number 643010	Samara
Russian Federation	Investigational Site Number 643011	Saratov
Russian Federation	Investigational Site Number 643059	Smolensk
Russian Federation	Investigational Site Number 643008	St-Petersburg
Russian Federation	Investigational Site Number 643058	St. Peterburg
Russian Federation	Investigational Site Number 643013	Ufa
Russian Federation	Investigational Site Number 643050	Voronezh
Russian Federation	Investigational Site Number 643051	Yaroslavl
Russian Federation	Investigational Site Number 643057	Yaroslavl
South Africa	Investigational Site Number 710007	Cape Town
South Africa	Investigational Site Number 710011	Cape Town
South Africa	Investigational Site Number 710006	Pretoria
South Africa	Investigational Site Number 710008	Pretoria
South Africa	Investigational Site Number 710010	Stellenbsoch
Spain	Investigational Site Number 724043	Córdoba
Spain	Investigational Site Number 724009	La Coruña
Spain	Investigational Site Number 724040	Madrid
Spain	Investigational Site Number 724041	Madrid
Spain	Investigational Site Number 724042	Madrid
Spain	Investigational Site Number 724001	Málaga
Spain	Investigational Site Number 724011	Sabadell
Spain	Investigational Site Number 724012	Santiago De Compostela
Taiwan	Investigational Site Number 158010	Changhua
Taiwan	Investigational Site Number 158004	Chia-Yi
Taiwan	Investigational Site Number 158011	Kaohsiung
Taiwan	Investigational Site Number 158012	Kaohsiung
Taiwan	Investigational Site Number 158006	Taipei
Thailand	Investigational Site Number 764002	Bangkok
Thailand	Investigational Site Number 764010	Bangkok
Thailand	Investigational Site Number 764003	Bangkok-Noi
Thailand	Investigational Site Number 764011	Khon Kaen
Ukraine	Investigational Site Number 804003	Dnipropetrovsk
Ukraine	Investigational Site Number 804002	Donetsk
Ukraine	Investigational Site Number 804024	Donetsk
Ukraine	Investigational Site Number 804029	Ivano-Frankivsk
Ukraine	Investigational Site Number 804010	Kharkiv
Ukraine	Investigational Site Number 804001	Kharkov
Ukraine	Investigational Site Number 804025	Kiev
Ukraine	Investigational Site Number 804011	Kyiv
Ukraine	Investigational Site Number 804014	Kyiv
Ukraine	Investigational Site Number 804023	Kyiv
Ukraine	Investigational Site Number 804027	Kyiv
Ukraine	Investigational Site Number 804030	Lutsk
Ukraine	Investigational Site Number 804005	Lviv
Ukraine	Investigational Site Number 804020	Lviv
Ukraine	Investigational Site Number 804033	Lviv
Ukraine	Investigational Site Number 804022	Odesa
Ukraine	Investigational Site Number 804032	Odesa
Ukraine	Investigational Site Number 804012	Odessa
Ukraine	Investigational Site Number 804021	Simferopol
Ukraine	Investigational Site Number 804028	Zaporozhye
Ukraine	Investigational Site Number 804031	Zhytomyr
United Kingdom	Investigational Site Number 826023	Barnsley
United Kingdom	Investigational Site Number 826022	Birmingham
United Kingdom	Investigational Site Number 826021	Dudley
United Kingdom	Investigational Site Number 826026	Durham
United Kingdom	Investigational Site Number 826027	Durham
United Kingdom	Investigational Site Number 826020	Harlow
United Kingdom	Investigational Site Number 826025	Wigan
United States	Investigational Site Number 840204	Battle Creek	Michigan
United States	Investigational Site Number 840004	Birmingham	Alabama
United States	Investigational Site Number 840124	Clarksburg	West Virginia
United States	Investigational Site Number 840210	Clearwater	Florida
United States	Investigational Site Number 840073	Cumberland	Maryland
United States	Investigational Site Number 840209	Danbury	Connecticut
United States	Investigational Site Number 840201	Denver	Colorado
United States	Investigational Site Number 840212	Glendale	California
United States	Investigational Site Number 840202	Hagerstown	Maryland
United States	Investigational Site Number 840018	Idaho Falls	Idaho
United States	Investigational Site Number 840213	Indianapolis	Indiana
United States	Investigational Site Number 840025	Jackson	Tennessee
United States	Investigational Site Number 840200	Jackson	Mississippi
United States	Investigational Site Number 840109	Lake Charles	Louisiana
United States	Investigational Site Number 840150	Lansing	Michigan
United States	Investigational Site Number 840112	Lincoln	Nebraska
United States	Investigational Site Number 840074	Mesquite	Texas
United States	Investigational Site Number 840056	New York	New York
United States	Investigational Site Number 840016	North Charleston	South Carolina
United States	Investigational Site Number 840128	Ormond Beach	Florida
United States	Investigational Site Number 840063	Palm Harbor	Florida
United States	Investigational Site Number 840117	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840060	Sarasota	Florida
United States	Investigational Site Number 840061	Tacoma	Washington
United States	Investigational Site Number 840207	Tampa	Florida
United States	Investigational Site Number 840211	Thousand Oaks	California
United States	Investigational Site Number 840037	Tupelo	Mississippi
United States	Investigational Site Number 840049	Upland	California
United States	Investigational Site Number 840205	Victorville	California
United States	Investigational Site Number 840203	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Chile,  Colombia,  Czech Republic,  Ecuador,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  New Zealand,  Peru,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP score) score change from baseline (randomized treatment phase)		Week 24	No
Secondary	Number of patients with American College of Rheumatology (ACR) efficacy response rates of 20%, 50% and 70%		Week 24	No
Secondary	Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) remission score (<2.6) incidence rate		Week 24	No
Secondary	Change from baseline in Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) score		Week 12	No