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

NCT01061736 | Completed Phase 2 Results DMC

• 2 other identifiers: EFC110722009-016266-90
• Study Type: interventional
• Target: 1,675
• Locations: 33 countries
• Sites: 246

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

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

  Baseline up to Week 52

Study Arms (10)

Part A: SAR 100 mg qw

EXPERIMENTAL

Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.

Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid

Part A: SAR 150 mg qw

EXPERIMENTAL

Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.

Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid

Part A: SAR 100 mg q2w

EXPERIMENTAL

Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.

Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

Part A: SAR 150 mg q2w

EXPERIMENTAL

Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

Part A: SAR 200 mg q2w

EXPERIMENTAL

Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

Part A: Placebo qw

PLACEBO COMPARATOR

Placebo (for sarilumab) qw on top of MTX for 12 weeks.

Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

Part B Cohort 1: Non-selected Doses

EXPERIMENTAL

Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).

Drug: Sarilumab; Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

EXPERIMENTAL

Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid

Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

EXPERIMENTAL

Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

Drug: Sarilumab; Drug: Methotrexate; Drug: Folic Acid

Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)

EXPERIMENTAL

Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

Drug: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic Acid

Interventions

Sarilumab DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: SAR153191, REGN88

Part A: SAR 100 mg q2w; Part A: SAR 100 mg qw; Part A: SAR 150 mg q2w; Part A: SAR 150 mg qw; Part A: SAR 200 mg q2w; Part B Cohort 1: Non-selected Doses; Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2); Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

Placebo (for sarilumab) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Part A: Placebo qw; Part A: SAR 100 mg q2w; Part A: SAR 150 mg q2w; Part A: SAR 200 mg q2w; Part B Cohort 1: Non-selected Doses; Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)

Methotrexate DRUG

Same weekly dose as received prior to enrollment

Part A: Placebo qw; Part A: SAR 100 mg q2w; Part A: SAR 100 mg qw; Part A: SAR 150 mg q2w; Part A: SAR 150 mg qw; Part A: SAR 200 mg q2w; Part B Cohort 1: Non-selected Doses; Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2); Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2); Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

Folic Acid DRUG

According to local standard

Part A: Placebo qw; Part A: SAR 100 mg q2w; Part A: SAR 100 mg qw; Part A: SAR 150 mg q2w; Part A: SAR 150 mg qw; Part A: SAR 200 mg q2w; Part B Cohort 1: Non-selected Doses; Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2); Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2); Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (262)

Investigational Site Number 840070

Anniston, Alabama, 36207, United States

Location

Investigational Site Number 840004

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 840072

Gilbert, Arizona, 85234, United States

Location

Investigational Site Number 840029

Beverly Hills, California, 90211, United States

Location

Investigational Site Number 840007

Palm Desert, California, 92260, United States

Location

Investigational Site Number 840008

San Francisco, California, 94143, United States

Location

Investigational Site Number 840021

Santa Maria, California, 94354, United States

Location

Investigational Site Number 840049

Upland, California, 91786, United States

Location

Investigational Site Number 840050

Dunedin, Florida, 34698, United States

Location

Investigational Site Number 840041

Jacksonville, Florida, 32209, United States

Location

Investigational Site Number 840067

Jupiter, Florida, 33458, United States

Location

Investigational Site Number 840048

Miami, Florida, 33155, United States

Location

Investigational Site Number 840006

Orlando, Florida, 32806, 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 840003

Atlanta, Georgia, 30322, United States

Location

Investigational Site Number 840028

Decatur, Georgia, 30033, United States

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Investigational Site Number 840027

Marietta, Georgia, 30060, United States

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Investigational Site Number 840018

Idaho Falls, Idaho, 83404, United States

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Investigational Site Number 840046

Chicago, Illinois, 60612, United States

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Investigational Site Number 840015

Lexington, Kentucky, 40504, United States

Location

Investigational Site Number 840073

Cumberland, Maryland, 21502, United States

Location

Investigational Site Number 840055

Frederick, Maryland, 21702, United States

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Investigational Site Number 840013

Wheaton, Maryland, 20902, United States

Location

Investigational Site Number 840066

St Louis, Missouri, 63117, United States

Location

Investigational Site Number 840071

Omaha, Nebraska, 68114, United States

Location

Investigational Site Number 840056

New York, New York, 10016, United States

Location

Investigational Site Number 840068

Hickory, North Carolina, 28601, United States

Location

Investigational Site Number 840044

Toledo, Ohio, 43606, United States

Location

Investigational Site Number 840002

Oklahoma City, Oklahoma, 73103, United States

Location

Investigational Site Number 840011

Tulsa, Oklahoma, 74104, United States

Location

Investigational Site Number 840065

Tulsa, Oklahoma, 74135, United States

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Investigational Site Number 840010

Bethlehem, Pennsylvania, 18015, United States

Location

Investigational Site Number 840009

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site Number 840062

Reading, Pennsylvania, 19611, United States

Location

Investigational Site Number 840058

Columbia, South Carolina, 29204, 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 840001

Dallas, Texas, 75231, United States

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Investigational Site Number 840022

Dallas, Texas, 75235, United States

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Investigational Site Number 840012

Dallas, Texas, 75390, United States

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Investigational Site Number 840020

Houston, Texas, 77034, United States

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Investigational Site Number 840069

Lubbock, Texas, 79424, United States

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Investigational Site Number 840074

Mesquite, Texas, 75150, United States

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Investigational Site Number 840061

Tacoma, Washington, 98405, United States

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Investigational Site Number 032005

Buenos Aires, 4000, Argentina

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Investigational Site Number 032007

Buenos Aires, Argentina

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Investigational Site Number 032008

Buenos Aires, Argentina

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Investigational Site Number 032006

Caba, C1015ABO, Argentina

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Investigational Site Number 032002

Córdoba, X5004BAL, Argentina

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Investigational Site Number 032003

Córdoba, Argentina

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Investigational Site Number 032012

Mar del Plata, B7600, Argentina

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Investigational Site Number 032011

Quilmes, B1878DVB, Argentina

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Investigational Site Number 032010

Ramos Mejía, 1704, Argentina

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Investigational Site Number 032001

Rosario, 2000, Argentina

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Investigational Site Number 032004

San Miguel de Tucumán, 4000, Argentina

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Investigational Site Number 032009

Zárate, 2800, Argentina

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Investigational Site Number 036003

Camperdown, 2050, Australia

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Investigational Site Number 036005

Clayton, 3168, Australia

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Investigational Site Number 036012

Fitzroy, 3065, Australia

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Investigational Site Number 036010

Garran, 2605, Australia

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Investigational Site Number 036004

Heidelberg West, 3081, Australia

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Investigational Site Number 036009

Herston, 4029, Australia

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Investigational Site Number 036002

Malvern East, 3145, Australia

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Investigational Site Number 036001

Maroochydore, 4558, Australia

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Investigational Site Number 036006

St Leonards, 2065, Australia

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Investigational Site Number 036011

Sydney, 2035, Australia

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Investigational Site Number 036014

Victoria Park, 6100, Australia

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Investigational Site Number 036007

Woodville, 5011, Australia

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Investigational Site Number 040001

Graz, 8036, Austria

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Investigational Site Number 040002

Vienna, 1100, Austria

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Investigational Site Number 112002

Minsk, 220037, Belarus

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Investigational Site Number 112001

Minsk, 220116, Belarus

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Investigational Site Number 056003

Genk, 3600, Belgium

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Investigational Site Number 056001

Liège, 4000, Belgium

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Investigational Site Number 076008

Campinas, 13015-001, Brazil

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Investigational Site Number 076012

Campinas, 13083-970, Brazil

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Investigational Site Number 076001

Curitiba, 80060-240, Brazil

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Investigational Site Number 076006

Goiânia, 74110-120, Brazil

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Investigational Site Number 076010

Juiz de Fora, 36010-570, Brazil

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Investigational Site Number 076004

Porto Alegre, 90610-000, Brazil

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Investigational Site Number 076005

Rio de Janeiro, 20551-030, Brazil

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Investigational Site Number 076011

Salvador, 40050-410, Brazil

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Investigational Site Number 076002

São Paulo, 04039-901, Brazil

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Investigational Site Number 076003

São Paulo, 04230 000, Brazil

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Investigational Site Number 076013

Vitória, 29055 450, Brazil

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Investigational Site Number 124004

Burlington, L7R 1E2, Canada

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Investigational Site Number 124003

Mississauga, L5M 2V8, Canada

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Investigational Site Number 124008

Newmarket, L3Y 3R7, Canada

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Investigational Site Number 124002

St. Catharines, L2N 7E4, Canada

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Investigational Site Number 124005

Toronto, M5T 2S8, Canada

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Investigational Site Number 124001

Toronto, M9R 2Y8, Canada

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Investigational Site Number 124012

Winnipeg, R3A 1M3, Canada

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Investigational Site Number 152005

Osorno, Chile

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Investigational Site Number 152010

Port Montt, Chile

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Investigational Site Number 152012

Santiago, 7500922, Chile

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Investigational Site Number 152001

Santiago, Chile

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Investigational Site Number 152002

Santiago, Chile

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Investigational Site Number 152008

Santiago, Chile

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Investigational Site Number 152009

Santiago, Chile

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Investigational Site Number 152011

Santiago, Chile

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Investigational Site Number 152013

Santiago, Chile

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Investigational Site Number 152014

Talca, 3460000, Chile

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Investigational Site Number 152004

Valdivia, Chile

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Investigational Site Number 152007

Viña del Mar, 2570017, Chile

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Investigational Site Number 152006

Viña del Mar, Chile

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Investigational Site Number 170004

Barranquilla, Colombia

Location

Investigational Site Number 170001

Bogotá, Colombia

Location

Investigational Site Number 170003

Bogotá, Colombia

Location

Investigational Site Number 170006

Bogotá, Colombia

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Investigational Site Number 170008

Bogotá, Colombia

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Investigational Site Number 170007

Bucaramanga, Colombia

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Investigational Site Number 170009

Bucaramanga, Colombia

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Investigational Site Number 170002

Medellín, Colombia

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Investigational Site Number 203005

Brno, 63801, Czechia

Location

Investigational Site Number 203004

Hlučín, 74801, Czechia

Location

Investigational Site Number 203001

Prague, 12850, Czechia

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Investigational Site Number 203002

Uherské Hradiště, 68601, Czechia

Location

Investigational Site Number 818001

Cairo, Egypt

Location

Investigational Site Number 818002

Cairo, Egypt

Location

Investigational Site Number 233001

Tallinn, 10128, Estonia

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Investigational Site Number 233002

Tallinn, 13419, Estonia

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Investigational Site Number 246001

Helsinki, 00290, Finland

Location

Investigational Site Number 246002

Hyvinkää, 05800, Finland

Location

Investigational Site Number 246003

Pori, 28100, Finland

Location

Investigational Site Number 276007

Berlin, 12161, Germany

Location

Investigational Site Number 276008

Berlin, 12161, Germany

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Investigational Site Number 276004

Erlangen, 91054, Germany

Location

Investigational Site Number 276003

Frankfurt am Main, 60590, Germany

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Investigational Site Number 276015

Halle, 06108, Germany

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Investigational Site Number 276005

Hamburg, 22081, Germany

Location

Investigational Site Number 276013

Hamburg, 22147, Germany

Location

Investigational Site Number 276012

Heidelberg, 69120, Germany

Location

Investigational Site Number 276001

Herne, 44652, Germany

Location

Investigational Site Number 276006

Hildesheim, 31134, Germany

Location

Investigational Site Number 300001

Athens, 11527, Greece

Location

Investigational Site Number 300002

Heraklion, 71110, Greece

Location

Investigational Site Number 300003

Thessaloniki, 546 36, Greece

Location

Investigational Site Number 348006

Budapest, 1023, Hungary

Location

Investigational Site Number 348014

Budapest, 1027, Hungary

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Investigational Site Number 348003

Debrecen, 4032, Hungary

Location

Investigational Site Number 348010

Debrecen, 4043, Hungary

Location

Investigational Site Number 348011

Eger, 3300, Hungary

Location

Investigational Site Number 348013

Gy?r, 9025, Hungary

Location

Investigational Site Number 348005

Sátoraljaújhely, 3980, Hungary

Location

Investigational Site Number 348015

Szombathely, H-9700, Hungary

Location

Investigational Site Number 348004

Veszprém, 8200, Hungary

Location

Investigational Site Number 356015

Ahmedabad, 380009, India

Location

Investigational Site Number 356007

Bangalore, 560079, India

Location

Investigational Site Number 356003

Chennai, 600004, India

Location

Investigational Site Number 356012

Hyderabad, 500003, India

Location

Investigational Site Number 356005

Hyderabad, 500004, India

Location

Investigational Site Number 356011

Lucknow, 226003, India

Location

Investigational Site Number 356013

Lucknow, 226014, India

Location

Investigational Site Number 356001

Maharashtra, 411 001, India

Location

Investigational Site Number 356010

Mumbai, 400008, India

Location

Investigational Site Number 356004

Mumbai, 400012, India

Location

Investigational Site Number 356002

New Delhi, 122001, India

Location

Investigational Site Number 356008

New Delhi, 76, India

Location

Investigational Site Number 440001

Kaunas, LT-50009, Lithuania

Location

Investigational Site Number 440002

Vilnius, LT-08661, Lithuania

Location

Investigational Site Number 458001

Ipoh, 30990, Malaysia

Location

Investigational Site Number 458002

Kuching, 93586, Malaysia

Location

Investigational Site Number 458003

Putrajaya, Malaysia

Location

Investigational Site Number 484008

Durango, 34270, Mexico

Location

Investigational Site Number 484002

Guadalajara, 44690, Mexico

Location

Investigational Site Number 484007

Metepec, 52140, Mexico

Location

Investigational Site Number 484001

Mexico City, 11850, Mexico

Location

Investigational Site Number 484003

Mexico City, 6726, Mexico

Location

Investigational Site Number 484004

Mérida, 97000, Mexico

Location

Investigational Site Number 484009

Mérida, 97000, Mexico

Location

Investigational Site Number 484005

Monterrey, 64000, Mexico

Location

Investigational Site Number 528002

Heerlen, 6419 PC, Netherlands

Location

Investigational Site Number 554004

Christchurch, 8002, New Zealand

Location

Investigational Site Number 554002

Rotorua, New Zealand

Location

Investigational Site Number 554003

Tauranga, 3001, New Zealand

Location

Investigational Site Number 554001

Timaru, New Zealand

Location

Investigational Site Number 578004

Kristiansand, 4604, Norway

Location

Investigational Site Number 578006

Tønsberg, 3105, Norway

Location

Investigational Site Number 608003

Cebu City, 6000, Philippines

Location

Investigational Site Number 608001

Manila, 1008, Philippines

Location

Investigational Site Number 608002

Manila, Philippines

Location

Investigational Site Number 616002

Bialystok, 15-354, Poland

Location

Investigational Site Number 616003

Bialystok, 15-461, Poland

Location

Investigational Site Number 616001

Krakow, 30-510, Poland

Location

Investigational Site Number 616005

Lublin, 20-607, Poland

Location

Investigational Site Number 616006

Torun, 87-100, Poland

Location

Investigational Site Number 616004

Warsaw, 02-118, Poland

Location

Investigational Site Number 616012

Wroclaw, 50-044, Poland

Location

Investigational Site Number 620003

Aveiro, 3814-501, Portugal

Location

Investigational Site Number 620001

Lisbon, 1649-035, Portugal

Location

Investigational Site Number 620002

Lisbon, Portugal

Location

Investigational Site Number 642006

Brăila, 810019, Romania

Location

Investigational Site Number 642001

Bucharest, 010976, Romania

Location

Investigational Site Number 642002

Bucharest, 020983, Romania

Location

Investigational Site Number 642003

Bucharest, 400347, Romania

Location

Investigational Site Number 642004

Bucharest, Romania

Location

Investigational Site Number 642010

Bucharest, Romania

Location

Investigational Site Number 642005

Galati, 800578, Romania

Location

Investigational Site Number 642008

Ploieşti, Romania

Location

Investigational Site Number 643017

Kemerovo, 650066, Russia

Location

Investigational Site Number 643006

Kemerovo, 650099, Russia

Location

Investigational Site Number 643004

Moscow, 107014, Russia

Location

Investigational Site Number 643020

Moscow, 115404, Russia

Location

Investigational Site Number 643001

Moscow, 115522, Russia

Location

Investigational Site Number 643002

Moscow, 117997, Russia

Location

Investigational Site Number 643012

Moscow, 121359, Russia

Location

Investigational Site Number 643009

Novosibirsk, 630099, Russia

Location

Investigational Site Number 643016

Ryazan, 390026, Russia

Location

Investigational Site Number 643007

Saint Petersburg, 190068, Russia

Location

Investigational Site Number 643008

Saint Petersburg, 192242, Russia

Location

Investigational Site Number 643014

Saint Petersburg, 196247, Russia

Location

Investigational Site Number 643010

Samara, 443095, Russia

Location

Investigational Site Number 643011

Saratov, 410053, Russia

Location

Investigational Site Number 643013

Ufa, 450005, Russia

Location

Investigational Site Number 710011

Cape Town, 7405, South Africa

Location

Investigational Site Number 710007

Cape Town, 7530, South Africa

Location

Investigational Site Number 710009

Cape Town, 8001, South Africa

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Investigational Site Number 710003

Durban, 4001, South Africa

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Investigational Site Number 710002

Durban, 4091, South Africa

Location

Investigational Site Number 710001

Johannesburg, 2013, South Africa

Location

Investigational Site Number 710004

Kempton Park, 1619, South Africa

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Investigational Site Number 710005

Pretoria, 0075, South Africa

Location

Investigational Site Number 710006

Pretoria, 0182, South Africa

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Investigational Site Number 710008

Pretoria, South Africa

Location

Investigational Site Number 710010

Stellenbosch, 7600, South Africa

Location

Investigational Site Number 410014

Anyang, 431-070, South Korea

Location

Investigational Site Number 410006

Busan, 602-739, South Korea

Location

Investigational Site Number 410004

Daegu, 700-721, South Korea

Location

Investigational Site Number 410013

Daegu, 705-718, South Korea

Location

Investigational Site Number 410005

Daejeon, 302-799, South Korea

Location

Investigational Site Number 410010

Gwangju, 501-757, South Korea

Location

Investigational Site Number 410009

Incheon, 400-711, South Korea

Location

Investigational Site Number 410001

Incheon, South Korea

Location

Investigational Site Number 410011

Jeonju, 561-712, South Korea

Location

Investigational Site Number 410007

Seoul, 110-744, South Korea

Location

Investigational Site Number 410012

Seoul, 133-792, South Korea

Location

Investigational Site Number 410003

Seoul, 150-713, South Korea

Location

Investigational Site Number 410002

Seoul, 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 724010

Barcelona, 08025, Spain

Location

Investigational Site Number 724011

Sabadell, 08208, Spain

Location

Investigational Site Number 724012

Santiago de Compostela, 15705, Spain

Location

Investigational Site Number 724007

Seville, 41008, Spain

Location

Investigational Site Number 158002

Linkou District, 333, Taiwan

Location

Investigational Site Number 158001

Taipei, 100, Taiwan

Location

Investigational Site Number 764001

Bangkok, 10400, Thailand

Location

Investigational Site Number 764003

Bangkok, 10700, Thailand

Location

Investigational Site Number 792003

Adana, 01330, Turkey (Türkiye)

Location

Investigational Site Number 792002

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 792005

Ankara, Turkey (Türkiye)

Location

Investigational Site Number 792004

Antalya, 07059, Turkey (Türkiye)

Location

Investigational Site Number 792001

Izmir, 35340, Turkey (Türkiye)

Location

Investigational Site Number 804003

Dnipropetrovsk, 49008, Ukraine

Location

Investigational Site Number 804002

Donetsk, 83114, Ukraine

Location

Investigational Site Number 804010

Kharkiv, 61022, Ukraine

Location

Investigational Site Number 804008

Kyiv, 01023, Ukraine

Location

Investigational Site Number 804004

Kyiv, 03151, Ukraine

Location

Investigational Site Number 804005

Lviv, 79005, Ukraine

Location

Investigational Site Number 804006

Simferopol, 95017, Ukraine

Location

Investigational Site Number 804009

Zaporizhzhia, 69600, Ukraine

Location

Related Publications (12)

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

  PMID: 27600829 BACKGROUND

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

  PMID: 24297381 RESULT

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

  PMID: 25733246 RESULT

• Choy E, Bykerk V, Lee YC, van Hoogstraten H, Ford K, Praestgaard A, Perrot S, Pope J, Sebba A. Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab. Rheumatology (Oxford). 2023 Jul 5;62(7):2386-2393. doi: 10.1093/rheumatology/keac659.

  PMID: 36413080 DERIVED

• Rubbert-Roth A, Furst DE, Fiore S, Praestgaard A, Bykerk V, Bingham CO, Charles-Schoeman C, Burmester G. Association between low hemoglobin, clinical measures, and patient-reported outcomes in patients with rheumatoid arthritis: results from post hoc analyses of three phase III trials of sarilumab. Arthritis Res Ther. 2022 Aug 25;24(1):207. doi: 10.1186/s13075-022-02891-x.

  PMID: 36008838 DERIVED

• Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14.

  PMID: 34519964 DERIVED

• Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, John GS, Gonzalez-Gay MA, Mandrup-Poulsen T, Fleischmann R. Interleukin-6 receptor blockade or TNFalpha inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020 Sep 9;22(1):206. doi: 10.1186/s13075-020-02229-5.

  PMID: 32907617 DERIVED

• Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z.

  PMID: 32522251 DERIVED

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

  PMID: 32343882 DERIVED

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

  PMID: 31452928 DERIVED

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

  PMID: 31004324 DERIVED

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

  PMID: 27716324 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab; Methotrexate; Folic Acid

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)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Mark C Genovese, MD, Professor of Medicine

  Division of Immunology and Rheumatology - Stanford University - USA

  PRINCIPAL INVESTIGATOR

• TWJ Huizinga, Prof Dr

  Dpt of Rheumatology - Leiden University Medical Center - The Netherlands

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-06

Locations

IN (12); MY (3); GR (3); AR (12); BE (2); LI (2); KR (14); ZA (11); CL (13); CO (8); US (45); TH (2); ME (8); PT (3); CZ (4); FI (3); PL (7); AU (2); EG (2); ES (5); NL (1); RO (8); UA (8); RU (15); HU (9); BR (11); TW (2); CA (7); NZ (4); DE (10); PH (3); TU (5); NO (2)