Back to results

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Sarilumab SAR153191 (REGN88)

Placebo (for sarilumab)

Methotrexate

Folic acid

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion criteria:

Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with >=3 months disease duration.
Moderately to severely active RA defined as:
At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit.

Exclusion criteria:

Participants <20 or >75 years of age.
Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Sarilumab 150 mg/150 mg

Sarilumab 200 mg/200 mg

Placebo/Sarilumab 150 mg

Placebo/Sarilumab 200 mg

Arm Description

Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either tender joint count [TJC] or swollen joint count [SJC], or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24

American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent.

Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg Orthostatic systolic blood pressure (SBP[O]): <=-20 mmHg Orthostatic diastolic blood pressure (DBP[O]): <=-10 mmHg Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm Weight: >=5% DFB; >=5% IFB

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

Criteria for potentially clinically significant ECG abnormalities: PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25% QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25% QT Interval: >500 ms QTc Bazett (QTc B): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms QTc Fridericia (QTc F): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters

Criteria for potentially clinically significant abnormalities: Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F) Red blood cells (RBC): >=6 Tera/L Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L White blood cells (WBC): <3.0 Giga/L (Non-Black[NB]) or <2.0 Giga/L (Black[B]); >=16.0 Giga/L Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and < lower limit of normal (LLN); >4.0 Giga/L Monocytes: >0.7 Giga/L Basophils: >0.1 Giga/L Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters

Criteria for potentially clinically significant abnormalities: Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L unfasted or >=7 mmol/L fasted Hemoglobin A1c (HbA1c): >8% Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes

Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L Potassium: <3 mmol/L; >=5.5 mmol/L Chloride: <80 mmol/L; >115 mmol/L

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters

Criteria for potentially clinically significant abnormalities: Creatinine: >=150 micromol/L; >=30% change from baseline; >=100% change from baseline Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to < 60 mL/min; >=60 to <90 mL/min Blood urea nitrogen: >=17 mmol/L Uric acid: <120 micromol/L; >408 micromol/L

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters

Criteria for potentially clinically significant abnormalities: Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN Alkaline phosphatase: >1.5 ULN Total bilirubin (TBILI): >1.5 ULN; >2 ULN Conjugated bilirubin (CBILI): >1.5 ULN; >2 ULN Unconjugated bilirubin: >1.5 ULN; >2 ULN ALT and TBILI: ALT >3 ULN and TBILI >2 ULN CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN Albumin: <=25 g/L

Full Information

NCT ID

NCT02293902

First Posted

November 13, 2014

Last Updated

January 5, 2018

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02293902

Brief Title

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Official Title

A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. Secondary Objective: -To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

Detailed Description

The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

243 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sarilumab 150 mg/150 mg

Arm Type

Experimental

Arm Description

Arm Title

Sarilumab 200 mg/200 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo/Sarilumab 150 mg

Arm Type

Placebo Comparator

Arm Description

Arm Title

Placebo/Sarilumab 200 mg

Arm Type

Placebo Comparator

Arm Description

Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Intervention Type

Drug

Intervention Name(s)

Sarilumab SAR153191 (REGN88)

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type

Other

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

Dispensed according to local practice.

Intervention Type

Drug

Intervention Name(s)

Folic acid

Intervention Description

Dispensed according to local practice.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

Title

Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

Description

Time Frame

Title

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

Description

Time Frame

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters

Description

Time Frame

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters

Description

Time Frame

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes

Description

Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L Potassium: <3 mmol/L; >=5.5 mmol/L Chloride: <80 mmol/L; >115 mmol/L

Time Frame

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters

Description

Time Frame

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters

Description

Time Frame

For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with >=3 months disease duration. Moderately to severely active RA defined as: At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit. High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit. Exclusion criteria: Participants <20 or >75 years of age. Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening. Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab. The above information was 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

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 392010

City

Asahi-Shi

Country

Japan

Facility Name

Investigational Site Number 392001

City

Asahikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392035

City

Asahikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392070

City

Beppu-Shi

Country

Japan

Facility Name

Investigational Site Number 392036

City

Chiba-Shi

Country

Japan

Facility Name

Investigational Site Number 392083

City

Chuo-Ku

Country

Japan

Facility Name

Investigational Site Number 392047

City

Fuchu-Shi

Country

Japan

Facility Name

Investigational Site Number 392004

City

Fukui-Shi

Country

Japan

Facility Name

Investigational Site Number 392007

City

Fukuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392038

City

Fukuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392039

City

Fukuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392078

City

Fukushima-Shi

Country

Japan

Facility Name

Investigational Site Number 392054

City

Funabashi-Shi

Country

Japan

Facility Name

Investigational Site Number 392015

City

Hachioji-Shi

Country

Japan

Facility Name

Investigational Site Number 392085

City

Hannan-Shi

Country

Japan

Facility Name

Investigational Site Number 392091

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392098

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392009

City

Hitachinaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392011

City

Hitachinaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392030

City

Ichinomiya-Shi

Country

Japan

Facility Name

Investigational Site Number 392002

City

Iizuka-Shi

Country

Japan

Facility Name

Investigational Site Number 392019

City

Kagoshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392066

City

Kamakura-Shi

Country

Japan

Facility Name

Investigational Site Number 392086

City

Kamogawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392050

City

Kato-Shi

Country

Japan

Facility Name

Investigational Site Number 392037

City

Kawachi-Nagano-Shi

Country

Japan

Facility Name

Investigational Site Number 392093

City

Kawagoe-Shi

Country

Japan

Facility Name

Investigational Site Number 392099

City

Kawasaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392016

City

Kirishima-Shi

Country

Japan

Facility Name

Investigational Site Number 392013

City

Kitakyushu-Shi

Country

Japan

Facility Name

Investigational Site Number 392024

City

Kitakyushu-Shi

Country

Japan

Facility Name

Investigational Site Number 392045

City

Kitakyushu-Shi

Country

Japan

Facility Name

Investigational Site Number 392063

City

Kiyose-Shi

Country

Japan

Facility Name

Investigational Site Number 392051

City

Kobe-Shi

Country

Japan

Facility Name

Investigational Site Number 392097

City

Kochi-Shi

Country

Japan

Facility Name

Investigational Site Number 392040

City

Koushi-Shi

Country

Japan

Facility Name

Investigational Site Number 392069

City

Kumamoto-Shi

Country

Japan

Facility Name

Investigational Site Number 392089

City

Kurashiki-Shi

Country

Japan

Facility Name

Investigational Site Number 392065

City

Kushiro-Shi

Country

Japan

Facility Name

Investigational Site Number 392026

City

Matsuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392081

City

Matsuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392094

City

Matsuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392042

City

Meguro-Ku

Country

Japan

Facility Name

Investigational Site Number 392082

City

Meguro-Ku

Country

Japan

Facility Name

Investigational Site Number 392012

City

Mito-Shi

Country

Japan

Facility Name

Investigational Site Number 392034

City

Miyagi-Gun

Country

Japan

Facility Name

Investigational Site Number 392053

City

Morioka-Shi

Country

Japan

Facility Name

Investigational Site Number 392032

City

Nagano-Shi

Country

Japan

Facility Name

Investigational Site Number 392064

City

Nagasaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392043

City

Nagoya-Shi

Country

Japan

Facility Name

Investigational Site Number 392056

City

Nagoya-Shi

Country

Japan

Facility Name

Investigational Site Number 392076

City

Nagoya-Shi

Country

Japan

Facility Name

Investigational Site Number 392080

City

Nagoya-Shi

Country

Japan

Facility Name

Investigational Site Number 392031

City

Nakano-Ku

Country

Japan

Facility Name

Investigational Site Number 392046

City

Narashino-Shi

Country

Japan

Facility Name

Investigational Site Number 392067

City

Narashino-Shi

Country

Japan

Facility Name

Investigational Site Number 392044

City

Nishinomiya-Shi

Country

Japan

Facility Name

Investigational Site Number 392059

City

Oita-Shi

Country

Japan

Facility Name

Investigational Site Number 392062

City

Okayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392008

City

Omura-Shi

Country

Japan

Facility Name

Investigational Site Number 392057

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392060

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392061

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392096

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392027

City

Osaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392049

City

Sagamihara-Shi

Country

Japan

Facility Name

Investigational Site Number 392072

City

Saitama-Shi

Country

Japan

Facility Name

Investigational Site Number 392075

City

Sakai-Shi

Country

Japan

Facility Name

Investigational Site Number 392014

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392068

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392073

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392006

City

Sasebo-Shi

Country

Japan

Facility Name

Investigational Site Number 392021

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 392022

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 392033

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 392071

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 392100

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 392029

City

Shizuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392025

City

Sumida-Ku

Country

Japan

Facility Name

Investigational Site Number 392092

City

Sumida-Ku

Country

Japan

Facility Name

Investigational Site Number 392023

City

Takaoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392095

City

Takarazuka-Shi

Country

Japan

Facility Name

Investigational Site Number 392020

City

Takasaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392088

City

Takatsuki-Shi

Country

Japan

Facility Name

Investigational Site Number 392018

City

Tokorozawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392003

City

Tomakomai-Shi

Country

Japan

Facility Name

Investigational Site Number 392005

City

Tomakomai-Shi

Country

Japan

Facility Name

Investigational Site Number 392077

City

Tonami-Shi

Country

Japan

Facility Name

Investigational Site Number 392052

City

Toshima-Ku

Country

Japan

Facility Name

Investigational Site Number 392058

City

Toyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392055

City

Toyonaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392074

City

Urasoe-Shi

Country

Japan

Facility Name

Investigational Site Number 392079

City

Urayasu-Shi

Country

Japan

Facility Name

Investigational Site Number 392048

City

Yokohama-Shi

Country

Japan

Facility Name

Investigational Site Number 392090

City

Yokohama-Shi

Country

Japan

Facility Name

Investigational Site Number 392101

City

Yokohama-Shi

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

36305354

Citation

Tanaka Y, Takahashi T, Van Hoogstraten H, Praestgaard A, Kato N, Kameda H. Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab. Clin Exp Rheumatol. 2023 May;41(5):1129-1139. doi: 10.55563/clinexprheumatol/jq9u8f. Epub 2022 Oct 28.

Results Reference

derived

PubMed Identifier

30894208

Citation

Tanaka Y, Wada K, Takahashi Y, Hagino O, van Hoogstraten H, Graham NMH, Kameda H. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan. Arthritis Res Ther. 2019 Mar 20;21(1):79. doi: 10.1186/s13075-019-1856-4. Erratum In: Arthritis Res Ther. 2019 Apr 16;21(1):99.

Results Reference

derived

Learn more about this trial

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

We'll reach out to this number within 24 hrs

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial