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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01061736
Other study ID # EFC11072
Secondary ID 2009-016266-90
Status Completed
Phase Phase 2/Phase 3
First received February 2, 2010
Last updated June 27, 2017
Start date March 2010
Est. completion date October 2013

Study information

Verified date June 2017
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 1675
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria :

- 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:

- Bone erosion based on documented X-ray prior to first study drug intake, or

- Cyclic Citrullinated Peptide (CCP) positive, or

- Rheumatoid Factor (RF) positive.

Exclusion criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo (for sarilumab)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Methotrexate
Same weekly dose as received prior to enrollment
Folic Acid
According to local standard

Locations

Country Name City State
Argentina Investigational Site Number 032005 Buenos Aires
Argentina Investigational Site Number 032007 Buenos Aires
Argentina Investigational Site Number 032008 Buenos Aires
Argentina Investigational Site Number 032006 Caba
Argentina Investigational Site Number 032002 Cordoba
Argentina Investigational Site Number 032003 Córdoba
Argentina Investigational Site Number 032012 Mar Del Plata
Argentina Investigational Site Number 032011 Quilmes
Argentina Investigational Site Number 032010 Ramos Mejia
Argentina Investigational Site Number 032001 Rosario
Argentina Investigational Site Number 032004 Tucuman
Argentina Investigational Site Number 032009 Zarate
Australia Investigational Site Number 036003 Camperdown
Australia Investigational Site Number 036005 Clayton
Australia Investigational Site Number 036002 East Malvern
Australia Investigational Site Number 036012 Fitzroy
Australia Investigational Site Number 036010 Garran
Australia Investigational Site Number 036004 Heidelberg West
Australia Investigational Site Number 036009 Herston
Australia Investigational Site Number 036001 Maroochydore
Australia Investigational Site Number 036006 St Leonards
Australia Investigational Site Number 036011 Sydney
Australia Investigational Site Number 036014 Victoria Park
Australia Investigational Site Number 036007 Woodville
Austria Investigational Site Number 040001 Graz
Austria Investigational Site Number 040002 Wien
Belarus Investigational Site Number 112001 Minsk
Belarus Investigational Site Number 112002 Minsk
Belgium Investigational Site Number 056003 Genk
Belgium Investigational Site Number 056001 Liège
Brazil Investigational Site Number 076008 Campinas
Brazil Investigational Site Number 076012 Campinas
Brazil Investigational Site Number 076001 Curitiba
Brazil Investigational Site Number 076006 Goiania
Brazil Investigational Site Number 076010 Juiz De Fora
Brazil Investigational Site Number 076004 Porto Alegre
Brazil Investigational Site Number 076005 Rio De Janeiro
Brazil Investigational Site Number 076011 Salvador
Brazil Investigational Site Number 076002 Sao Paulo
Brazil Investigational Site Number 076003 Sao Paulo
Brazil Investigational Site Number 076013 Vitoria
Canada Investigational Site Number 124004 Burlington
Canada Investigational Site Number 124003 Mississauga
Canada Investigational Site Number 124008 Newmarket
Canada Investigational Site Number 124002 St. Catharines
Canada Investigational Site Number 124001 Toronto
Canada Investigational Site Number 124005 Toronto
Canada Investigational Site Number 124012 Winnipeg
Chile Investigational Site Number 152005 Osorno
Chile Investigational Site Number 152010 Puerto Montt
Chile Investigational Site Number 152001 Santiago
Chile Investigational Site Number 152002 Santiago
Chile Investigational Site Number 152008 Santiago
Chile Investigational Site Number 152009 Santiago
Chile Investigational Site Number 152011 Santiago
Chile Investigational Site Number 152012 Santiago
Chile Investigational Site Number 152013 Santiago
Chile Investigational Site Number 152014 Talca
Chile Investigational Site Number 152004 Valdivia
Chile Investigational Site Number 152006 Vina Del Mar
Chile Investigational Site Number 152007 Viña Del Mar
Colombia Investigational Site Number 170004 Barranquilla
Colombia Investigational Site Number 170001 Bogota
Colombia Investigational Site Number 170008 Bogota
Colombia Investigational Site Number 170003 Bogotá
Colombia Investigational Site Number 170006 Bogotá
Colombia Investigational Site Number 170007 Bucaramanga
Colombia Investigational Site Number 170009 Bucaramanga
Colombia Investigational Site Number 170002 Medellin
Czechia Investigational Site Number 203005 Brno
Czechia Investigational Site Number 203004 Hlucin
Czechia Investigational Site Number 203001 Praha 2
Czechia Investigational Site Number 203002 Uherske Hradiste
Egypt Investigational Site Number 818001 Cairo
Egypt Investigational Site Number 818002 Cairo
Estonia Investigational Site Number 233001 Tallinn
Estonia Investigational Site Number 233002 Tallinn
Finland Investigational Site Number 246001 Helsinki
Finland Investigational Site Number 246002 Hyvinkää
Finland Investigational Site Number 246003 Pori
Germany Investigational Site Number 276007 Berlin
Germany Investigational Site Number 276008 Berlin
Germany Investigational Site Number 276004 Erlangen
Germany Investigational Site Number 276003 Frankfurt Am Main
Germany Investigational Site Number 276015 Halle/Saale
Germany Investigational Site Number 276005 Hamburg
Germany Investigational Site Number 276013 Hamburg
Germany Investigational Site Number 276012 Heidelberg
Germany Investigational Site Number 276001 Herne
Germany Investigational Site Number 276006 Hildesheim
Greece Investigational Site Number 300001 Athens
Greece Investigational Site Number 300002 Heraklion
Greece Investigational Site Number 300003 Thessaloniki
Hungary Investigational Site Number 348006 Budapest
Hungary Investigational Site Number 348014 Budapest
Hungary Investigational Site Number 348003 Debrecen
Hungary Investigational Site Number 348010 Debrecen
Hungary Investigational Site Number 348011 Eger
Hungary Investigational Site Number 348013 Gy?r
Hungary Investigational Site Number 348005 Sátoraljaújhely
Hungary Investigational Site Number 348015 Szombathely
Hungary Investigational Site Number 348004 Veszprém
India Investigational Site Number 356015 Ahmedabad
India Investigational Site Number 356007 Bangalore
India Investigational Site Number 356003 Chennai
India Investigational Site Number 356005 Hyderabad
India Investigational Site Number 356012 Hyderabad
India Investigational Site Number 356011 Lucknow
India Investigational Site Number 356013 Lucknow
India Investigational Site Number 356001 Maharashtra
India Investigational Site Number 356004 Mumbai
India Investigational Site Number 356010 Mumbai
India Investigational Site Number 356002 New Delhi
India Investigational Site Number 356008 New Delhi
Korea, Republic of Investigational Site Number 410014 Anyang
Korea, Republic of Investigational Site Number 410006 Busan
Korea, Republic of Investigational Site Number 410004 Daegu
Korea, Republic of Investigational Site Number 410013 Daegu
Korea, Republic of Investigational Site Number 410005 Daejeon
Korea, Republic of Investigational Site Number 410010 Gwangju
Korea, Republic of Investigational Site Number 410001 Incheon
Korea, Republic of Investigational Site Number 410009 Incheon
Korea, Republic of Investigational Site Number 410011 Jeonju
Korea, Republic of Investigational Site Number 410002 Seoul
Korea, Republic of Investigational Site Number 410003 Seoul
Korea, Republic of Investigational Site Number 410007 Seoul
Korea, Republic of Investigational Site Number 410012 Seoul
Korea, Republic of Investigational Site Number 410008 Suwon
Lithuania Investigational Site Number 440001 Kaunas
Lithuania Investigational Site Number 440002 Vilnius
Malaysia Investigational Site Number 458001 Ipoh
Malaysia Investigational Site Number 458002 Kuching
Malaysia Investigational Site Number 458003 Putrajaya
Mexico Investigational Site Number 484008 Durango
Mexico Investigational Site Number 484002 Guadalajara
Mexico Investigational Site Number 484004 Merida
Mexico Investigational Site Number 484009 Merida
Mexico Investigational Site Number 484007 Metepec
Mexico Investigational Site Number 484003 Mexico City
Mexico Investigational Site Number 484001 Mexico, D.F.
Mexico Investigational Site Number 484005 Monterrey
Netherlands Investigational Site Number 528002 Heerlen
New Zealand Investigational Site Number 554004 Christchurch
New Zealand Investigational Site Number 554002 Rotorua
New Zealand Investigational Site Number 554003 Tauranga
New Zealand Investigational Site Number 554001 Timaru
Norway Investigational Site Number 578004 Kristiansand
Norway Investigational Site Number 578006 Tønsberg
Philippines Investigational Site Number 608003 Cebu City
Philippines Investigational Site Number 608001 Manila
Philippines Investigational Site Number 608002 Manila
Poland Investigational Site Number 616002 Bialystok
Poland Investigational Site Number 616003 Bialystok
Poland Investigational Site Number 616001 Krakow
Poland Investigational Site Number 616005 Lublin
Poland Investigational Site Number 616006 Torun
Poland Investigational Site Number 616004 Warszawa
Poland Investigational Site Number 616012 Wroclaw
Portugal Investigational Site Number 620003 Aveiro
Portugal Investigational Site Number 620001 Lisboa
Portugal Investigational Site Number 620002 Lisboa
Romania Investigational Site Number 642006 Braila
Romania Investigational Site Number 642004 Bucharest
Romania Investigational Site Number 642010 Bucharest
Romania Investigational Site Number 642001 Bucuresti
Romania Investigational Site Number 642002 Bucuresti
Romania Investigational Site Number 642003 Bucuresti
Romania Investigational Site Number 642005 Galati
Romania Investigational Site Number 642008 Ploiesti
Russian Federation Investigational Site Number 643006 Kemerovo
Russian Federation Investigational Site Number 643017 Kemerovo
Russian Federation Investigational Site Number 643001 Moscow
Russian Federation Investigational Site Number 643002 Moscow
Russian Federation Investigational Site Number 643004 Moscow
Russian Federation Investigational Site Number 643012 Moscow
Russian Federation Investigational Site Number 643020 Moscow
Russian Federation Investigational Site Number 643009 Novosibirsk
Russian Federation Investigational Site Number 643016 Ryazan
Russian Federation Investigational Site Number 643014 Saint-Petersburg
Russian Federation Investigational Site Number 643010 Samara
Russian Federation Investigational Site Number 643011 Saratov
Russian Federation Investigational Site Number 643007 St-Petersburg
Russian Federation Investigational Site Number 643008 St-Petersburg
Russian Federation Investigational Site Number 643013 Ufa
South Africa Investigational Site Number 710007 Cape Town
South Africa Investigational Site Number 710009 Cape Town
South Africa Investigational Site Number 710011 Cape Town
South Africa Investigational Site Number 710002 Durban
South Africa Investigational Site Number 710003 Durban
South Africa Investigational Site Number 710001 Johannesburg
South Africa Investigational Site Number 710004 Kempton Park
South Africa Investigational Site Number 710005 Pretoria
South Africa Investigational Site Number 710006 Pretoria
South Africa Investigational Site Number 710008 Pretoria
South Africa Investigational Site Number 710010 Stellenbosch
Spain Investigational Site Number 724010 Barcelona
Spain Investigational Site Number 724009 La Coruña
Spain Investigational Site Number 724011 Sabadell
Spain Investigational Site Number 724012 Santiago De Compostela
Spain Investigational Site Number 724007 Sevilla
Taiwan Investigational Site Number 158002 Linkou
Taiwan Investigational Site Number 158001 Taipei
Thailand Investigational Site Number 764001 Bangkok
Thailand Investigational Site Number 764003 Bangkok
Turkey Investigational Site Number 792003 Adana
Turkey Investigational Site Number 792002 Ankara
Turkey Investigational Site Number 792005 Ankara
Turkey Investigational Site Number 792004 Antalya
Turkey Investigational Site Number 792001 Izmir
Ukraine Investigational Site Number 804003 Dnipropetrovsk
Ukraine Investigational Site Number 804002 Donetsk
Ukraine Investigational Site Number 804010 Kharkov
Ukraine Investigational Site Number 804004 Kyiv
Ukraine Investigational Site Number 804008 Kyiv
Ukraine Investigational Site Number 804005 Lviv
Ukraine Investigational Site Number 804006 Simferopol
Ukraine Investigational Site Number 804009 Zaporizhzhia
United States Investigational Site Number 840070 Anniston Alabama
United States Investigational Site Number 840003 Atlanta Georgia
United States Investigational Site Number 840010 Bethlehem Pennsylvania
United States Investigational Site Number 840029 Beverly Hills California
United States Investigational Site Number 840004 Birmingham Alabama
United States Investigational Site Number 840046 Chicago Illinois
United States Investigational Site Number 840058 Columbia South Carolina
United States Investigational Site Number 840073 Cumberland Maryland
United States Investigational Site Number 840001 Dallas Texas
United States Investigational Site Number 840012 Dallas Texas
United States Investigational Site Number 840022 Dallas Texas
United States Investigational Site Number 840028 Decatur Georgia
United States Investigational Site Number 840009 Duncansville Pennsylvania
United States Investigational Site Number 840050 Dunedin Florida
United States Investigational Site Number 840055 Frederick Maryland
United States Investigational Site Number 840072 Gilbert Arizona
United States Investigational Site Number 840068 Hickory North Carolina
United States Investigational Site Number 840020 Houston Texas
United States Investigational Site Number 840018 Idaho Falls Idaho
United States Investigational Site Number 840025 Jackson Tennessee
United States Investigational Site Number 840041 Jacksonville Florida
United States Investigational Site Number 840067 Jupiter Florida
United States Investigational Site Number 840015 Lexington Kentucky
United States Investigational Site Number 840069 Lubbock Texas
United States Investigational Site Number 840027 Marietta Georgia
United States Investigational Site Number 840074 Mesquite Texas
United States Investigational Site Number 840048 Miami Florida
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 840002 Oklahoma City Oklahoma
United States Investigational Site Number 840071 Omaha Nebraska
United States Investigational Site Number 840006 Orlando Florida
United States Investigational Site Number 840007 Palm Desert California
United States Investigational Site Number 840063 Palm Harbor Florida
United States Investigational Site Number 840062 Reading Pennsylvania
United States Investigational Site Number 840066 Saint Louis Missouri
United States Investigational Site Number 840008 San Francisco California
United States Investigational Site Number 840021 Santa Maria California
United States Investigational Site Number 840060 Sarasota Florida
United States Investigational Site Number 840061 Tacoma Washington
United States Investigational Site Number 840044 Toledo Ohio
United States Investigational Site Number 840011 Tulsa Oklahoma
United States Investigational Site Number 840065 Tulsa Oklahoma
United States Investigational Site Number 840049 Upland California
United States Investigational Site Number 840013 Wheaton Maryland

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czechia,  Egypt,  Estonia,  Finland,  Germany,  Greece,  Hungary,  India,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine, 

References & Publications (3)

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 P — View Citation

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-6Ra in patients with rheumatoid arthritis and an inadequate response to metho — View Citation

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;18:198. doi: 10.1186/s13075-016-1096-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline to Week 12
Primary 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. Baseline to Week 24
Primary 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. Baseline, Week 16
Primary 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. Baseline, Week 52
Secondary 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. Baseline up to Week 52
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