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

NCT ID: NCT01061736

Last Updated: 2017-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Related Clinical Trials

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Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

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Rheumatoid Arthritis
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A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

NCT06073093

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COMPLETED PHASE2

To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

NCT02121210

Rheumatoid Arthritis
COMPLETED PHASE3

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

NCT01764997

Rheumatoid Arthritis
TERMINATED PHASE3

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

NCT01709578

Rheumatoid Arthritis
COMPLETED PHASE3

Detailed Description

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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).

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Part A: SAR 100 mg qw

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

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Part A: SAR 150 mg qw

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

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Part A: SAR 100 mg q2w

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

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Placebo (for sarilumab)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Part A: SAR 150 mg q2w

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

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Placebo (for sarilumab)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Part A: SAR 200 mg q2w

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

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Placebo (for sarilumab)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Part A: Placebo qw

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

Group Type PLACEBO_COMPARATOR

Placebo (for sarilumab)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Part B Cohort 1: Non-selected Doses

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).

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Placebo (for sarilumab)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

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

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.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

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

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.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

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

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.

Group Type EXPERIMENTAL

Placebo (for sarilumab)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Methotrexate

Intervention Type DRUG

Same weekly dose as received prior to enrollment

Folic Acid

Intervention Type DRUG

According to local standard

Interventions

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Sarilumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type DRUG

Placebo (for sarilumab)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type DRUG

Methotrexate

Same weekly dose as received prior to enrollment

Intervention Type DRUG

Folic Acid

According to local standard

Intervention Type DRUG

Other Intervention Names

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SAR153191 REGN88

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark C Genovese, MD, Professor of Medicine

Role: PRINCIPAL_INVESTIGATOR

Division of Immunology and Rheumatology - Stanford University - USA

TWJ Huizinga, Prof Dr

Role: STUDY_CHAIR

Dpt of Rheumatology - Leiden University Medical Center - The Netherlands

Locations

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Investigational Site Number 233002

Tallinn, , Estonia

Site Status

Investigational Site Number 246001

Helsinki, , Finland

Site Status

Investigational Site Number 246002

Hyvinkää, , Finland

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Investigational Site Number 246003

Pori, , Finland

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Investigational Site Number 276007

Berlin, , Germany

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Investigational Site Number 276008

Berlin, , Germany

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Investigational Site Number 276004

Erlangen, , Germany

Site Status

Investigational Site Number 818001

Cairo, , Egypt

Site Status

Investigational Site Number 818002

Cairo, , Egypt

Site Status

Investigational Site Number 233001

Tallinn, , Estonia

Site Status

Investigational Site Number 840070

Anniston, Alabama, United States

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Investigational Site Number 840004

Birmingham, Alabama, United States

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Investigational Site Number 840072

Gilbert, Arizona, United States

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Investigational Site Number 840029

Beverly Hills, California, United States

Site Status

Investigational Site Number 840007

Palm Desert, California, United States

Site Status

Investigational Site Number 840008

San Francisco, California, United States

Site Status

Investigational Site Number 840021

Santa Maria, California, United States

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Investigational Site Number 840049

Upland, California, United States

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Investigational Site Number 840050

Dunedin, Florida, United States

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Investigational Site Number 840041

Jacksonville, Florida, United States

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Investigational Site Number 840067

Jupiter, Florida, United States

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Investigational Site Number 840048

Miami, Florida, United States

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Investigational Site Number 840006

Orlando, Florida, United States

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Investigational Site Number 840063

Palm Harbor, Florida, United States

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Investigational Site Number 840060

Sarasota, Florida, United States

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Investigational Site Number 840003

Atlanta, Georgia, United States

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Investigational Site Number 840028

Decatur, Georgia, United States

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Investigational Site Number 840027

Marietta, Georgia, United States

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Investigational Site Number 840018

Idaho Falls, Idaho, United States

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Investigational Site Number 840046

Chicago, Illinois, United States

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Investigational Site Number 840015

Lexington, Kentucky, United States

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Investigational Site Number 840073

Cumberland, Maryland, United States

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Investigational Site Number 840055

Frederick, Maryland, United States

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Investigational Site Number 840013

Wheaton, Maryland, United States

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Investigational Site Number 840066

St Louis, Missouri, United States

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Investigational Site Number 840071

Omaha, Nebraska, United States

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Investigational Site Number 840056

New York, New York, United States

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Investigational Site Number 840068

Hickory, North Carolina, United States

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Investigational Site Number 840044

Toledo, Ohio, United States

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Investigational Site Number 840002

Oklahoma City, Oklahoma, United States

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Investigational Site Number 840011

Tulsa, Oklahoma, United States

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Investigational Site Number 840065

Tulsa, Oklahoma, United States

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Investigational Site Number 840010

Bethlehem, Pennsylvania, United States

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Investigational Site Number 840009

Duncansville, Pennsylvania, United States

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Investigational Site Number 840062

Reading, Pennsylvania, United States

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Investigational Site Number 840058

Columbia, South Carolina, United States

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Investigational Site Number 840016

North Charleston, South Carolina, United States

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Investigational Site Number 840025

Jackson, Tennessee, United States

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Investigational Site Number 840001

Dallas, Texas, United States

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Investigational Site Number 840022

Dallas, Texas, United States

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Investigational Site Number 840012

Dallas, Texas, United States

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Investigational Site Number 840020

Houston, Texas, United States

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Investigational Site Number 840069

Lubbock, Texas, United States

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Investigational Site Number 840074

Mesquite, Texas, United States

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Investigational Site Number 840061

Tacoma, Washington, United States

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Investigational Site Number 032005

Buenos Aires, , 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, , Argentina

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Investigational Site Number 032002

Córdoba, , Argentina

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Investigational Site Number 032003

Córdoba, , Argentina

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Investigational Site Number 032012

Mar del Plata, , Argentina

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Investigational Site Number 032011

Quilmes, , Argentina

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Investigational Site Number 032010

Ramos Mejía, , Argentina

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Investigational Site Number 032001

Rosario, , Argentina

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Investigational Site Number 032004

San Miguel de Tucumán, , Argentina

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Investigational Site Number 032009

Zárate, , Argentina

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Investigational Site Number 036003

Camperdown, , Australia

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Investigational Site Number 036005

Clayton, , Australia

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Investigational Site Number 036012

Fitzroy, , Australia

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Investigational Site Number 036010

Garran, , Australia

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Investigational Site Number 036004

Heidelberg West, , Australia

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Investigational Site Number 036009

Herston, , Australia

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Investigational Site Number 036002

Malvern East, , Australia

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Investigational Site Number 036001

Maroochydore, , Australia

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Investigational Site Number 036006

St Leonards, , Australia

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Investigational Site Number 036011

Sydney, , Australia

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Investigational Site Number 036014

Victoria Park, , Australia

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Investigational Site Number 036007

Woodville, , Australia

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Investigational Site Number 040001

Graz, , Austria

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Investigational Site Number 040002

Vienna, , Austria

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Investigational Site Number 112002

Minsk, , Belarus

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Investigational Site Number 112001

Minsk, , Belarus

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Investigational Site Number 056003

Genk, , Belgium

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Investigational Site Number 056001

Liège, , Belgium

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Investigational Site Number 076008

Campinas, , Brazil

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Investigational Site Number 076012

Campinas, , Brazil

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Investigational Site Number 076001

Curitiba, , Brazil

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Investigational Site Number 076006

Goiânia, , Brazil

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Investigational Site Number 076010

Juiz de Fora, , Brazil

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Investigational Site Number 076004

Porto Alegre, , Brazil

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Investigational Site Number 076005

Rio de Janeiro, , Brazil

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Salvador, , Brazil

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Investigational Site Number 076002

São Paulo, , Brazil

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Investigational Site Number 076003

São Paulo, , Brazil

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Investigational Site Number 076013

Vitória, , Brazil

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Investigational Site Number 124004

Burlington, , Canada

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Investigational Site Number 124003

Mississauga, , Canada

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Investigational Site Number 124008

Newmarket, , Canada

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Investigational Site Number 124002

St. Catharines, , Canada

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Investigational Site Number 124005

Toronto, , Canada

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Investigational Site Number 124001

Toronto, , Canada

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Winnipeg, , Canada

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Osorno, , Chile

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Port Montt, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Investigational Site Number 152014

Talca, , Chile

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Investigational Site Number 152004

Valdivia, , Chile

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Investigational Site Number 152007

Viña del Mar, , Chile

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Investigational Site Number 152006

Viña del Mar, , Chile

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Investigational Site Number 170004

Barranquilla, , Colombia

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Investigational Site Number 170001

Bogotá, , Colombia

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Investigational Site Number 170003

Bogotá, , Colombia

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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, , Czechia

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Investigational Site Number 203004

Hlučín, , Czechia

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Investigational Site Number 203001

Prague, , Czechia

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Investigational Site Number 203002

Uherské Hradiště, , Czechia

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Investigational Site Number 276003

Frankfurt am Main, , Germany

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Investigational Site Number 276015

Halle, , Germany

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Investigational Site Number 276005

Hamburg, , Germany

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Investigational Site Number 276013

Hamburg, , Germany

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Investigational Site Number 276012

Heidelberg, , Germany

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Investigational Site Number 276001

Herne, , Germany

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Investigational Site Number 276006

Hildesheim, , Germany

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Investigational Site Number 300001

Athens, , Greece

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Investigational Site Number 300002

Heraklion, , Greece

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Investigational Site Number 300003

Thessaloniki, , Greece

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Investigational Site Number 348006

Budapest, , Hungary

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Investigational Site Number 348014

Budapest, , Hungary

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Investigational Site Number 348003

Debrecen, , Hungary

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Investigational Site Number 348010

Debrecen, , Hungary

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Investigational Site Number 348011

Eger, , Hungary

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Investigational Site Number 348013

Gy?r, , Hungary

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Investigational Site Number 348005

Sátoraljaújhely, , Hungary

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Investigational Site Number 348015

Szombathely, , Hungary

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Investigational Site Number 348004

Veszprém, , Hungary

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Investigational Site Number 356015

Ahmedabad, , India

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Investigational Site Number 356007

Bangalore, , India

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Investigational Site Number 356003

Chennai, , India

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Investigational Site Number 356012

Hyderabad, , India

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Investigational Site Number 356005

Hyderabad, , India

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Investigational Site Number 356011

Lucknow, , India

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Investigational Site Number 356013

Lucknow, , India

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Investigational Site Number 356001

Maharashtra, , India

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Investigational Site Number 356010

Mumbai, , India

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Investigational Site Number 356004

Mumbai, , India

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Investigational Site Number 356002

New Delhi, , India

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Investigational Site Number 356008

New Delhi, , India

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Investigational Site Number 440001

Kaunas, , Lithuania

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Investigational Site Number 440002

Vilnius, , Lithuania

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Investigational Site Number 458001

Ipoh, , Malaysia

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Investigational Site Number 458002

Kuching, , Malaysia

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Investigational Site Number 458003

Putrajaya, , Malaysia

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Investigational Site Number 484008

Durango, , Mexico

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Investigational Site Number 484002

Guadalajara, , Mexico

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Investigational Site Number 484007

Metepec, , Mexico

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Investigational Site Number 484001

Mexico City, , Mexico

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Investigational Site Number 484003

Mexico City, , Mexico

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Investigational Site Number 484004

Mérida, , Mexico

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Investigational Site Number 484009

Mérida, , Mexico

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Investigational Site Number 484005

Monterrey, , Mexico

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Investigational Site Number 528002

Heerlen, , Netherlands

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Investigational Site Number 554004

Christchurch, , New Zealand

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Investigational Site Number 554002

Rotorua, , New Zealand

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Investigational Site Number 554003

Tauranga, , New Zealand

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Investigational Site Number 554001

Timaru, , New Zealand

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Investigational Site Number 578004

Kristiansand, , Norway

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Investigational Site Number 578006

Tønsberg, , Norway

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Investigational Site Number 608003

Cebu City, , Philippines

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Investigational Site Number 608001

Manila, , Philippines

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Investigational Site Number 608002

Manila, , Philippines

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Investigational Site Number 616002

Bialystok, , Poland

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Investigational Site Number 616003

Bialystok, , Poland

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Investigational Site Number 616001

Krakow, , Poland

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Investigational Site Number 616005

Lublin, , Poland

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Investigational Site Number 616006

Torun, , Poland

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Investigational Site Number 616004

Warsaw, , Poland

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Investigational Site Number 616012

Wroclaw, , Poland

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Investigational Site Number 620003

Aveiro, , Portugal

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Investigational Site Number 620001

Lisbon, , Portugal

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Investigational Site Number 620002

Lisbon, , Portugal

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Investigational Site Number 642006

Brăila, , Romania

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Investigational Site Number 642001

Bucharest, , Romania

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Investigational Site Number 642002

Bucharest, , Romania

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Investigational Site Number 642003

Bucharest, , Romania

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Investigational Site Number 642004

Bucharest, , Romania

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Investigational Site Number 642010

Bucharest, , Romania

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Investigational Site Number 642005

Galati, , Romania

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Investigational Site Number 642008

Ploieşti, , Romania

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Investigational Site Number 643017

Kemerovo, , Russia

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Investigational Site Number 643006

Kemerovo, , Russia

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Investigational Site Number 643004

Moscow, , Russia

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Investigational Site Number 643020

Moscow, , Russia

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Investigational Site Number 643001

Moscow, , Russia

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Investigational Site Number 643002

Moscow, , Russia

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Investigational Site Number 643012

Moscow, , Russia

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Investigational Site Number 643009

Novosibirsk, , Russia

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Investigational Site Number 643016

Ryazan, , Russia

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Investigational Site Number 643007

Saint Petersburg, , Russia

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Investigational Site Number 643008

Saint Petersburg, , Russia

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Investigational Site Number 643014

Saint Petersburg, , Russia

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Investigational Site Number 643010

Samara, , Russia

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Investigational Site Number 643011

Saratov, , Russia

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Investigational Site Number 643013

Ufa, , Russia

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Investigational Site Number 710011

Cape Town, , South Africa

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Investigational Site Number 710007

Cape Town, , South Africa

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Investigational Site Number 710009

Cape Town, , South Africa

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Investigational Site Number 710003

Durban, , South Africa

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Investigational Site Number 710002

Durban, , South Africa

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Investigational Site Number 710001

Johannesburg, , South Africa

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Investigational Site Number 710004

Kempton Park, , South Africa

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Investigational Site Number 710005

Pretoria, , South Africa

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Investigational Site Number 710006

Pretoria, , South Africa

Site Status

Investigational Site Number 710008

Pretoria, , South Africa

Site Status

Investigational Site Number 710010

Stellenbosch, , South Africa

Site Status

Investigational Site Number 410014

Anyang, , South Korea

Site Status

Investigational Site Number 410006

Busan, , South Korea

Site Status

Investigational Site Number 410004

Daegu, , South Korea

Site Status

Investigational Site Number 410013

Daegu, , South Korea

Site Status

Investigational Site Number 410005

Daejeon, , South Korea

Site Status

Investigational Site Number 410010

Gwangju, , South Korea

Site Status

Investigational Site Number 410009

Incheon, , South Korea

Site Status

Investigational Site Number 410001

Incheon, , South Korea

Site Status

Investigational Site Number 410011

Jeonju, , South Korea

Site Status

Investigational Site Number 410007

Seoul, , South Korea

Site Status

Investigational Site Number 410012

Seoul, , South Korea

Site Status

Investigational Site Number 410003

Seoul, , South Korea

Site Status

Investigational Site Number 410002

Seoul, , South Korea

Site Status

Investigational Site Number 410008

Suwon, , South Korea

Site Status

Investigational Site Number 724009

A Coruña, , Spain

Site Status

Investigational Site Number 724010

Barcelona, , Spain

Site Status

Investigational Site Number 724011

Sabadell, , Spain

Site Status

Investigational Site Number 724012

Santiago de Compostela, , Spain

Site Status

Investigational Site Number 724007

Seville, , Spain

Site Status

Investigational Site Number 158002

Linkou District, , Taiwan

Site Status

Investigational Site Number 158001

Taipei, , Taiwan

Site Status

Investigational Site Number 764001

Bangkok, , Thailand

Site Status

Investigational Site Number 764003

Bangkok, , Thailand

Site Status

Investigational Site Number 792003

Adana, , Turkey (Türkiye)

Site Status

Investigational Site Number 792002

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number 792005

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number 792004

Antalya, , Turkey (Türkiye)

Site Status

Investigational Site Number 792001

Izmir, , Turkey (Türkiye)

Site Status

Investigational Site Number 804003

Dnipropetrovsk, , Ukraine

Site Status

Investigational Site Number 804002

Donetsk, , Ukraine

Site Status

Investigational Site Number 804010

Kharkiv, , Ukraine

Site Status

Investigational Site Number 804008

Kyiv, , Ukraine

Site Status

Investigational Site Number 804004

Kyiv, , Ukraine

Site Status

Investigational Site Number 804005

Lviv, , Ukraine

Site Status

Investigational Site Number 804006

Simferopol, , Ukraine

Site Status

Investigational Site Number 804009

Zaporizhzhia, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27600829 (View on PubMed)

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.

Reference Type RESULT
PMID: 24297381 (View on PubMed)

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.

Reference Type RESULT
PMID: 25733246 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36413080 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36008838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34519964 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32907617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32522251 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32343882 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31452928 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31004324 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27716324 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-016266-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC11072

Identifier Type: -

Identifier Source: org_study_id

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