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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sarilumab
Placebo (for sarilumab)
Methotrexate
Folic Acid
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840070
  • Investigational Site Number 840004
  • Investigational Site Number 840072
  • Investigational Site Number 840029
  • Investigational Site Number 840007
  • Investigational Site Number 840008
  • Investigational Site Number 840021
  • Investigational Site Number 840049
  • Investigational Site Number 840050
  • Investigational Site Number 840041
  • Investigational Site Number 840067
  • Investigational Site Number 840048
  • Investigational Site Number 840006
  • Investigational Site Number 840063
  • Investigational Site Number 840060
  • Investigational Site Number 840003
  • Investigational Site Number 840028
  • Investigational Site Number 840027
  • Investigational Site Number 840018
  • Investigational Site Number 840046
  • Investigational Site Number 840015
  • Investigational Site Number 840073
  • Investigational Site Number 840055
  • Investigational Site Number 840013
  • Investigational Site Number 840066
  • Investigational Site Number 840071
  • Investigational Site Number 840056
  • Investigational Site Number 840068
  • Investigational Site Number 840044
  • Investigational Site Number 840002
  • Investigational Site Number 840011
  • Investigational Site Number 840065
  • Investigational Site Number 840010
  • Investigational Site Number 840009
  • Investigational Site Number 840062
  • Investigational Site Number 840058
  • Investigational Site Number 840016
  • Investigational Site Number 840025
  • Investigational Site Number 840001
  • Investigational Site Number 840022
  • Investigational Site Number 840012
  • Investigational Site Number 840020
  • Investigational Site Number 840069
  • Investigational Site Number 840074
  • Investigational Site Number 840061
  • Investigational Site Number 032005
  • Investigational Site Number 032007
  • Investigational Site Number 032008
  • Investigational Site Number 032006
  • Investigational Site Number 032002
  • Investigational Site Number 032003
  • Investigational Site Number 032012
  • Investigational Site Number 032011
  • Investigational Site Number 032010
  • Investigational Site Number 032001
  • Investigational Site Number 032004
  • Investigational Site Number 032009
  • Investigational Site Number 036003
  • Investigational Site Number 036005
  • Investigational Site Number 036002
  • Investigational Site Number 036012
  • Investigational Site Number 036010
  • Investigational Site Number 036004
  • Investigational Site Number 036009
  • Investigational Site Number 036001
  • Investigational Site Number 036006
  • Investigational Site Number 036011
  • Investigational Site Number 036014
  • Investigational Site Number 036007
  • Investigational Site Number 040001
  • Investigational Site Number 040002
  • Investigational Site Number 112002
  • Investigational Site Number 112001
  • Investigational Site Number 056003
  • Investigational Site Number 056001
  • Investigational Site Number 076008
  • Investigational Site Number 076012
  • Investigational Site Number 076001
  • Investigational Site Number 076006
  • Investigational Site Number 076010
  • Investigational Site Number 076004
  • Investigational Site Number 076005
  • Investigational Site Number 076011
  • Investigational Site Number 076002
  • Investigational Site Number 076003
  • Investigational Site Number 076013
  • Investigational Site Number 124004
  • Investigational Site Number 124003
  • Investigational Site Number 124008
  • Investigational Site Number 124002
  • Investigational Site Number 124005
  • Investigational Site Number 124001
  • Investigational Site Number 124012
  • Investigational Site Number 152005
  • Investigational Site Number 152010
  • Investigational Site Number 152012
  • Investigational Site Number 152001
  • Investigational Site Number 152002
  • Investigational Site Number 152008
  • Investigational Site Number 152009
  • Investigational Site Number 152011
  • Investigational Site Number 152013
  • Investigational Site Number 152014
  • Investigational Site Number 152004
  • Investigational Site Number 152006
  • Investigational Site Number 152007
  • Investigational Site Number 170004
  • Investigational Site Number 170001
  • Investigational Site Number 170008
  • Investigational Site Number 170003
  • Investigational Site Number 170006
  • Investigational Site Number 170007
  • Investigational Site Number 170009
  • Investigational Site Number 170002
  • Investigational Site Number 203005
  • Investigational Site Number 203004
  • Investigational Site Number 203001
  • Investigational Site Number 203002
  • Investigational Site Number 818001
  • Investigational Site Number 818002
  • Investigational Site Number 233001
  • Investigational Site Number 233002
  • Investigational Site Number 246001
  • Investigational Site Number 246002
  • Investigational Site Number 246003
  • Investigational Site Number 276007
  • Investigational Site Number 276008
  • Investigational Site Number 276004
  • Investigational Site Number 276003
  • Investigational Site Number 276015
  • Investigational Site Number 276005
  • Investigational Site Number 276013
  • Investigational Site Number 276012
  • Investigational Site Number 276001
  • Investigational Site Number 276006
  • Investigational Site Number 300001
  • Investigational Site Number 300002
  • Investigational Site Number 300003
  • Investigational Site Number 348006
  • Investigational Site Number 348014
  • Investigational Site Number 348003
  • Investigational Site Number 348010
  • Investigational Site Number 348011
  • Investigational Site Number 348013
  • Investigational Site Number 348015
  • Investigational Site Number 348005
  • Investigational Site Number 348004
  • Investigational Site Number 356015
  • Investigational Site Number 356007
  • Investigational Site Number 356003
  • Investigational Site Number 356012
  • Investigational Site Number 356005
  • Investigational Site Number 356011
  • Investigational Site Number 356013
  • Investigational Site Number 356001
  • Investigational Site Number 356010
  • Investigational Site Number 356004
  • Investigational Site Number 356002
  • Investigational Site Number 356008
  • Investigational Site Number 410014
  • Investigational Site Number 410006
  • Investigational Site Number 410004
  • Investigational Site Number 410013
  • Investigational Site Number 410005
  • Investigational Site Number 410010
  • Investigational Site Number 410009
  • Investigational Site Number 410001
  • Investigational Site Number 410011
  • Investigational Site Number 410007
  • Investigational Site Number 410012
  • Investigational Site Number 410003
  • Investigational Site Number 410002
  • Investigational Site Number 410008
  • Investigational Site Number 440001
  • Investigational Site Number 440002
  • Investigational Site Number 458001
  • Investigational Site Number 458002
  • Investigational Site Number 458003
  • Investigational Site Number 484008
  • Investigational Site Number 484002
  • Investigational Site Number 484004
  • Investigational Site Number 484009
  • Investigational Site Number 484007
  • Investigational Site Number 484003
  • Investigational Site Number 484001
  • Investigational Site Number 484005
  • Investigational Site Number 528002
  • Investigational Site Number 554004
  • Investigational Site Number 554002
  • Investigational Site Number 554003
  • Investigational Site Number 554001
  • Investigational Site Number 578004
  • Investigational Site Number 578006
  • Investigational Site Number 608003
  • Investigational Site Number 608001
  • Investigational Site Number 608002
  • Investigational Site Number 616002
  • Investigational Site Number 616003
  • Investigational Site Number 616001
  • Investigational Site Number 616005
  • Investigational Site Number 616006
  • Investigational Site Number 616004
  • Investigational Site Number 616012
  • Investigational Site Number 620003
  • Investigational Site Number 620001
  • Investigational Site Number 620002
  • Investigational Site Number 642006
  • Investigational Site Number 642004
  • Investigational Site Number 642010
  • Investigational Site Number 642001
  • Investigational Site Number 642002
  • Investigational Site Number 642003
  • Investigational Site Number 642005
  • Investigational Site Number 642008
  • Investigational Site Number 643017
  • Investigational Site Number 643006
  • Investigational Site Number 643004
  • Investigational Site Number 643020
  • Investigational Site Number 643001
  • Investigational Site Number 643002
  • Investigational Site Number 643012
  • Investigational Site Number 643009
  • Investigational Site Number 643016
  • Investigational Site Number 643014
  • Investigational Site Number 643010
  • Investigational Site Number 643011
  • Investigational Site Number 643007
  • Investigational Site Number 643008
  • Investigational Site Number 643013
  • Investigational Site Number 710011
  • Investigational Site Number 710007
  • Investigational Site Number 710009
  • Investigational Site Number 710003
  • Investigational Site Number 710002
  • Investigational Site Number 710001
  • Investigational Site Number 710004
  • Investigational Site Number 710005
  • Investigational Site Number 710006
  • Investigational Site Number 710008
  • Investigational Site Number 710010
  • Investigational Site Number 724010
  • Investigational Site Number 724009
  • Investigational Site Number 724011
  • Investigational Site Number 724012
  • Investigational Site Number 724007
  • Investigational Site Number 158002
  • Investigational Site Number 158001
  • Investigational Site Number 764001
  • Investigational Site Number 764003
  • Investigational Site Number 792003
  • Investigational Site Number 792002
  • Investigational Site Number 792005
  • Investigational Site Number 792004
  • Investigational Site Number 792001
  • Investigational Site Number 804003
  • Investigational Site Number 804002
  • Investigational Site Number 804010
  • Investigational Site Number 804008
  • Investigational Site Number 804004
  • Investigational Site Number 804005
  • Investigational Site Number 804006
  • Investigational Site Number 804009

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: SAR 100 mg qw

Part A: SAR 150 mg qw

Part A: SAR 100 mg q2w

Part A: SAR 150 mg q2w

Part A: SAR 200 mg q2w

Part A: Placebo qw

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)

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

Arm Description

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

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

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

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

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

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

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).

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2010
Last Updated
June 27, 2017
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01061736
Brief Title
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Acronym
RA-MOBILITY
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: SAR 100 mg qw
Arm Type
Experimental
Arm Description
Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.
Arm Title
Part A: SAR 150 mg qw
Arm Type
Experimental
Arm Description
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
Arm Title
Part A: SAR 100 mg q2w
Arm Type
Experimental
Arm Description
Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
Arm Title
Part A: SAR 150 mg q2w
Arm Type
Experimental
Arm Description
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
Arm Title
Part A: SAR 200 mg q2w
Arm Type
Experimental
Arm Description
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
Arm Title
Part A: Placebo qw
Arm Type
Placebo Comparator
Arm Description
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
Arm Title
Part B Cohort 1: Non-selected Doses
Arm Type
Experimental
Arm Description
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).
Arm Title
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sarilumab
Other Intervention Name(s)
SAR153191, REGN88
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo (for sarilumab)
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Same weekly dose as received prior to enrollment
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
According to local standard
Primary Outcome Measure Information:
Title
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Description
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).
Time Frame
Baseline to Week 12
Title
Part B: Percentage of Participants Achieving ACR20 Response at Week 24
Description
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.
Time Frame
Baseline to Week 24
Title
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
Description
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.
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
Description
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.
Time Frame
Baseline up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Genovese, MD, Professor of Medicine
Organizational Affiliation
Division of Immunology and Rheumatology - Stanford University - USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
TWJ Huizinga, Prof Dr
Organizational Affiliation
Dpt of Rheumatology - Leiden University Medical Center - The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site Number 840070
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Investigational Site Number 840004
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigational Site Number 840072
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Investigational Site Number 840029
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Investigational Site Number 840007
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Investigational Site Number 840008
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Investigational Site Number 840021
City
Santa Maria
State/Province
California
ZIP/Postal Code
94354
Country
United States
Facility Name
Investigational Site Number 840049
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Investigational Site Number 840050
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
Investigational Site Number 840041
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Investigational Site Number 840067
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Investigational Site Number 840048
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Investigational Site Number 840006
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 840063
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840060
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigational Site Number 840003
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Site Number 840028
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Investigational Site Number 840027
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Investigational Site Number 840018
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840046
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number 840015
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Investigational Site Number 840073
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Investigational Site Number 840055
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Investigational Site Number 840013
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Investigational Site Number 840066
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Investigational Site Number 840071
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Investigational Site Number 840056
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Investigational Site Number 840068
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Investigational Site Number 840044
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Investigational Site Number 840002
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Investigational Site Number 840011
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigational Site Number 840065
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Investigational Site Number 840010
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Investigational Site Number 840009
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigational Site Number 840062
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Investigational Site Number 840058
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Investigational Site Number 840016
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigational Site Number 840025
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Investigational Site Number 840001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840022
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Investigational Site Number 840012
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Investigational Site Number 840020
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigational Site Number 840069
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Investigational Site Number 840074
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Investigational Site Number 840061
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Investigational Site Number 032005
City
Buenos Aires
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Investigational Site Number 032007
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site Number 032008
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site Number 032006
City
Caba
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Investigational Site Number 032002
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Investigational Site Number 032003
City
Córdoba
Country
Argentina
Facility Name
Investigational Site Number 032012
City
Mar Del Plata
ZIP/Postal Code
B7600
Country
Argentina
Facility Name
Investigational Site Number 032011
City
Quilmes
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Investigational Site Number 032010
City
Ramos Mejia
ZIP/Postal Code
1704
Country
Argentina
Facility Name
Investigational Site Number 032001
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigational Site Number 032004
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Investigational Site Number 032009
City
Zarate
ZIP/Postal Code
2800
Country
Argentina
Facility Name
Investigational Site Number 036003
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Investigational Site Number 036005
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Investigational Site Number 036002
City
East Malvern
ZIP/Postal Code
3145
Country
Australia
Facility Name
Investigational Site Number 036012
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Investigational Site Number 036010
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Investigational Site Number 036004
City
Heidelberg West
ZIP/Postal Code
3081
Country
Australia
Facility Name
Investigational Site Number 036009
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Investigational Site Number 036001
City
Maroochydore
ZIP/Postal Code
4558
Country
Australia
Facility Name
Investigational Site Number 036006
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Investigational Site Number 036011
City
Sydney
ZIP/Postal Code
2035
Country
Australia
Facility Name
Investigational Site Number 036014
City
Victoria Park
ZIP/Postal Code
6100
Country
Australia
Facility Name
Investigational Site Number 036007
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
Investigational Site Number 040001
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number 040002
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Investigational Site Number 112002
City
Minsk
ZIP/Postal Code
220037
Country
Belarus
Facility Name
Investigational Site Number 112001
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Investigational Site Number 056003
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number 076008
City
Campinas
ZIP/Postal Code
13015-001
Country
Brazil
Facility Name
Investigational Site Number 076012
City
Campinas
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Investigational Site Number 076001
City
Curitiba
ZIP/Postal Code
80060-240
Country
Brazil
Facility Name
Investigational Site Number 076006
City
Goiania
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Investigational Site Number 076010
City
Juiz De Fora
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Investigational Site Number 076004
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Investigational Site Number 076005
City
Rio De Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Investigational Site Number 076011
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Investigational Site Number 076002
City
Sao Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Investigational Site Number 076003
City
Sao Paulo
ZIP/Postal Code
04230 000
Country
Brazil
Facility Name
Investigational Site Number 076013
City
Vitoria
ZIP/Postal Code
29055 450
Country
Brazil
Facility Name
Investigational Site Number 124004
City
Burlington
ZIP/Postal Code
L7R 1E2
Country
Canada
Facility Name
Investigational Site Number 124003
City
Mississauga
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Investigational Site Number 124008
City
Newmarket
ZIP/Postal Code
L3Y 3R7
Country
Canada
Facility Name
Investigational Site Number 124002
City
St. Catharines
ZIP/Postal Code
L2N 7E4
Country
Canada
Facility Name
Investigational Site Number 124005
City
Toronto
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Investigational Site Number 124001
City
Toronto
ZIP/Postal Code
M9R 2Y8
Country
Canada
Facility Name
Investigational Site Number 124012
City
Winnipeg
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Investigational Site Number 152005
City
Osorno
Country
Chile
Facility Name
Investigational Site Number 152010
City
Puerto Montt
Country
Chile
Facility Name
Investigational Site Number 152012
City
Santiago
ZIP/Postal Code
7500922
Country
Chile
Facility Name
Investigational Site Number 152001
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152002
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152008
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152009
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152011
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152013
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152014
City
Talca
ZIP/Postal Code
3460000
Country
Chile
Facility Name
Investigational Site Number 152004
City
Valdivia
Country
Chile
Facility Name
Investigational Site Number 152006
City
Vina Del Mar
Country
Chile
Facility Name
Investigational Site Number 152007
City
Viña Del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
Investigational Site Number 170004
City
Barranquilla
Country
Colombia
Facility Name
Investigational Site Number 170001
City
Bogota
Country
Colombia
Facility Name
Investigational Site Number 170008
City
Bogota
Country
Colombia
Facility Name
Investigational Site Number 170003
City
Bogotá
Country
Colombia
Facility Name
Investigational Site Number 170006
City
Bogotá
Country
Colombia
Facility Name
Investigational Site Number 170007
City
Bucaramanga
Country
Colombia
Facility Name
Investigational Site Number 170009
City
Bucaramanga
Country
Colombia
Facility Name
Investigational Site Number 170002
City
Medellin
Country
Colombia
Facility Name
Investigational Site Number 203005
City
Brno
ZIP/Postal Code
63801
Country
Czechia
Facility Name
Investigational Site Number 203004
City
Hlucin
ZIP/Postal Code
74801
Country
Czechia
Facility Name
Investigational Site Number 203001
City
Praha 2
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Investigational Site Number 203002
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Facility Name
Investigational Site Number 818001
City
Cairo
Country
Egypt
Facility Name
Investigational Site Number 818002
City
Cairo
Country
Egypt
Facility Name
Investigational Site Number 233001
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Investigational Site Number 233002
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site Number 246001
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Investigational Site Number 246002
City
Hyvinkää
ZIP/Postal Code
05800
Country
Finland
Facility Name
Investigational Site Number 246003
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Investigational Site Number 276007
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Investigational Site Number 276008
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Investigational Site Number 276004
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Investigational Site Number 276003
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigational Site Number 276015
City
Halle/Saale
ZIP/Postal Code
06108
Country
Germany
Facility Name
Investigational Site Number 276005
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Investigational Site Number 276013
City
Hamburg
ZIP/Postal Code
22147
Country
Germany
Facility Name
Investigational Site Number 276012
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Investigational Site Number 276001
City
Herne
ZIP/Postal Code
44652
Country
Germany
Facility Name
Investigational Site Number 276006
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Investigational Site Number 300001
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Investigational Site Number 300002
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Investigational Site Number 300003
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Investigational Site Number 348006
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Investigational Site Number 348014
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 348010
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Investigational Site Number 348011
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Investigational Site Number 348013
City
Gy?r
ZIP/Postal Code
9025
Country
Hungary
Facility Name
Investigational Site Number 348015
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Investigational Site Number 348005
City
Sátoraljaújhely
ZIP/Postal Code
3980
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Investigational Site Number 356015
City
Ahmedabad
ZIP/Postal Code
380009
Country
India
Facility Name
Investigational Site Number 356007
City
Bangalore
ZIP/Postal Code
560079
Country
India
Facility Name
Investigational Site Number 356003
City
Chennai
ZIP/Postal Code
600004
Country
India
Facility Name
Investigational Site Number 356012
City
Hyderabad
ZIP/Postal Code
500003
Country
India
Facility Name
Investigational Site Number 356005
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Investigational Site Number 356011
City
Lucknow
ZIP/Postal Code
226003
Country
India
Facility Name
Investigational Site Number 356013
City
Lucknow
ZIP/Postal Code
226014
Country
India
Facility Name
Investigational Site Number 356001
City
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Investigational Site Number 356010
City
Mumbai
ZIP/Postal Code
400008
Country
India
Facility Name
Investigational Site Number 356004
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Investigational Site Number 356002
City
New Delhi
ZIP/Postal Code
122001
Country
India
Facility Name
Investigational Site Number 356008
City
New Delhi
ZIP/Postal Code
76
Country
India
Facility Name
Investigational Site Number 410014
City
Anyang
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Investigational Site Number 410004
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Investigational Site Number 410013
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Investigational Site Number 410005
City
Daejeon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Investigational Site Number 410010
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Investigational Site Number 410009
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Investigational Site Number 410001
City
Incheon
Country
Korea, Republic of
Facility Name
Investigational Site Number 410011
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Investigational Site Number 410007
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 410012
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Investigational Site Number 410003
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Investigational Site Number 410002
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 410008
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Investigational Site Number 440001
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Investigational Site Number 440002
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Investigational Site Number 458001
City
Ipoh
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Investigational Site Number 458002
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Investigational Site Number 458003
City
Putrajaya
Country
Malaysia
Facility Name
Investigational Site Number 484008
City
Durango
ZIP/Postal Code
34270
Country
Mexico
Facility Name
Investigational Site Number 484002
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Investigational Site Number 484004
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigational Site Number 484009
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigational Site Number 484007
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Mexico City
ZIP/Postal Code
6726
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Mexico, D.F.
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Investigational Site Number 484005
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Investigational Site Number 528002
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Investigational Site Number 554004
City
Christchurch
ZIP/Postal Code
8002
Country
New Zealand
Facility Name
Investigational Site Number 554002
City
Rotorua
Country
New Zealand
Facility Name
Investigational Site Number 554003
City
Tauranga
ZIP/Postal Code
3001
Country
New Zealand
Facility Name
Investigational Site Number 554001
City
Timaru
Country
New Zealand
Facility Name
Investigational Site Number 578004
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Investigational Site Number 578006
City
Tønsberg
ZIP/Postal Code
3105
Country
Norway
Facility Name
Investigational Site Number 608003
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Investigational Site Number 608001
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Investigational Site Number 608002
City
Manila
Country
Philippines
Facility Name
Investigational Site Number 616002
City
Bialystok
ZIP/Postal Code
15-354
Country
Poland
Facility Name
Investigational Site Number 616003
City
Bialystok
ZIP/Postal Code
15-461
Country
Poland
Facility Name
Investigational Site Number 616001
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Investigational Site Number 616005
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Investigational Site Number 616006
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Investigational Site Number 616004
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Investigational Site Number 616012
City
Wroclaw
ZIP/Postal Code
50-044
Country
Poland
Facility Name
Investigational Site Number 620003
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Investigational Site Number 620001
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number 620002
City
Lisboa
Country
Portugal
Facility Name
Investigational Site Number 642006
City
Braila
ZIP/Postal Code
810019
Country
Romania
Facility Name
Investigational Site Number 642004
City
Bucharest
Country
Romania
Facility Name
Investigational Site Number 642010
City
Bucharest
Country
Romania
Facility Name
Investigational Site Number 642001
City
Bucuresti
ZIP/Postal Code
010976
Country
Romania
Facility Name
Investigational Site Number 642002
City
Bucuresti
ZIP/Postal Code
020983
Country
Romania
Facility Name
Investigational Site Number 642003
City
Bucuresti
ZIP/Postal Code
400347
Country
Romania
Facility Name
Investigational Site Number 642005
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Investigational Site Number 642008
City
Ploiesti
Country
Romania
Facility Name
Investigational Site Number 643017
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
Moscow
ZIP/Postal Code
107014
Country
Russian Federation
Facility Name
Investigational Site Number 643020
City
Moscow
ZIP/Postal Code
115404
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Investigational Site Number 643012
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Investigational Site Number 643009
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Investigational Site Number 643016
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Investigational Site Number 643014
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Investigational Site Number 643010
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Investigational Site Number 643011
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
St-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
St-Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Investigational Site Number 643013
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Investigational Site Number 710011
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Investigational Site Number 710007
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Investigational Site Number 710009
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Investigational Site Number 710003
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Investigational Site Number 710002
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 710001
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Investigational Site Number 710004
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Investigational Site Number 710005
City
Pretoria
ZIP/Postal Code
0075
Country
South Africa
Facility Name
Investigational Site Number 710006
City
Pretoria
ZIP/Postal Code
0182
Country
South Africa
Facility Name
Investigational Site Number 710008
City
Pretoria
Country
South Africa
Facility Name
Investigational Site Number 710010
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Investigational Site Number 724010
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Investigational Site Number 724009
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number 724011
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number 724012
City
Santiago De Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Investigational Site Number 724007
City
Sevilla
ZIP/Postal Code
41008
Country
Spain
Facility Name
Investigational Site Number 158002
City
Linkou
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Investigational Site Number 158001
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigational Site Number 764001
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Investigational Site Number 764003
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Investigational Site Number 792003
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Investigational Site Number 792002
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Investigational Site Number 792005
City
Ankara
Country
Turkey
Facility Name
Investigational Site Number 792004
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Investigational Site Number 792001
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Investigational Site Number 804003
City
Dnipropetrovsk
ZIP/Postal Code
49008
Country
Ukraine
Facility Name
Investigational Site Number 804002
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Investigational Site Number 804010
City
Kharkov
ZIP/Postal Code
61022
Country
Ukraine
Facility Name
Investigational Site Number 804008
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Investigational Site Number 804004
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Investigational Site Number 804005
City
Lviv
ZIP/Postal Code
79005
Country
Ukraine
Facility Name
Investigational Site Number 804006
City
Simferopol
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
Investigational Site Number 804009
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Citations:
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Learn more about this trial

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

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