MedPath

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)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Registration Number
NCT02293902
Lead Sponsor
Sanofi
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
243
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sarilumab 150 mg/150 mgSarilumab SAR153191 (REGN88)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 150 mg/150 mgFolic acidSarilumab 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.
Placebo/Sarilumab 150 mgPlacebo (for sarilumab)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.
Sarilumab 150 mg/150 mgMethotrexateSarilumab 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.
Placebo/Sarilumab 150 mgSarilumab SAR153191 (REGN88)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.
Sarilumab 200 mg/200 mgSarilumab SAR153191 (REGN88)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/Sarilumab 200 mgSarilumab SAR153191 (REGN88)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.
Placebo/Sarilumab 200 mgPlacebo (for sarilumab)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.
Sarilumab 200 mg/200 mgMethotrexateSarilumab 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.
Sarilumab 200 mg/200 mgFolic acidSarilumab 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/Sarilumab 150 mgMethotrexatePlacebo (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/Sarilumab 150 mgFolic acidPlacebo (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/Sarilumab 200 mgMethotrexatePlacebo (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.
Placebo/Sarilumab 200 mgFolic acidPlacebo (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.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24Week 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
NameTimeMethod
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic ParametersFor 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

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: Hematological ParametersFor 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

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: ElectrolytesFor 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

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 Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)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

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 AbnormalitiesFor 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

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) AbnormalitiesFor 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

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: Renal Function ParametersFor 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

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 ParametersFor 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

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

Trial Locations

Locations (96)

Investigational Site Number 392010

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Asahi-Shi, Japan

Investigational Site Number 392036

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Chiba-Shi, Japan

Investigational Site Number 392047

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Fuchu-Shi, Japan

Investigational Site Number 392083

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Chuo-Ku, Japan

Investigational Site Number 392007

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Fukuoka-Shi, Japan

Investigational Site Number 392039

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Fukuoka-Shi, Japan

Investigational Site Number 392091

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Hiroshima-Shi, Japan

Investigational Site Number 392078

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Fukushima-Shi, Japan

Investigational Site Number 392009

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Hitachinaka-Shi, Japan

Investigational Site Number 392085

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Hannan-Shi, Japan

Investigational Site Number 392015

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Hachioji-Shi, Japan

Investigational Site Number 392030

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Ichinomiya-Shi, Japan

Investigational Site Number 392002

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Iizuka-Shi, Japan

Investigational Site Number 392019

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Kagoshima-Shi, Japan

Investigational Site Number 392086

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Kamogawa-Shi, Japan

Investigational Site Number 392050

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Kato-Shi, Japan

Investigational Site Number 392037

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Kawachi-Nagano-Shi, Japan

Investigational Site Number 392093

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Kawagoe-Shi, Japan

Investigational Site Number 392099

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Kawasaki-Shi, Japan

Investigational Site Number 392016

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Kirishima-Shi, Japan

Investigational Site Number 392013

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Kitakyushu-Shi, Japan

Investigational Site Number 392024

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Kitakyushu-Shi, Japan

Investigational Site Number 392063

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Kiyose-Shi, Japan

Investigational Site Number 392097

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Kochi-Shi, Japan

Investigational Site Number 392051

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Kobe-Shi, Japan

Investigational Site Number 392040

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Koushi-Shi, Japan

Investigational Site Number 392065

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Kushiro-Shi, Japan

Investigational Site Number 392094

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Matsuyama-Shi, Japan

Investigational Site Number 392042

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Meguro-Ku, Japan

Investigational Site Number 392012

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Mito-Shi, Japan

Investigational Site Number 392034

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Miyagi-Gun, Japan

Investigational Site Number 392053

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Morioka-Shi, Japan

Investigational Site Number 392064

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Nagasaki-Shi, Japan

Investigational Site Number 392076

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Nagoya-Shi, Japan

Investigational Site Number 392031

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Nakano-Ku, Japan

Investigational Site Number 392046

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Narashino-Shi, Japan

Investigational Site Number 392067

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Narashino-Shi, Japan

Investigational Site Number 392044

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Nishinomiya-Shi, Japan

Investigational Site Number 392059

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Oita-Shi, Japan

Investigational Site Number 392062

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Okayama-Shi, Japan

Investigational Site Number 392060

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Osaka-Shi, Japan

Investigational Site Number 392057

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Osaka-Shi, Japan

Investigational Site Number 392061

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Osaka-Shi, Japan

Investigational Site Number 392027

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Osaki-Shi, Japan

Investigational Site Number 392096

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Osaka-Shi, Japan

Investigational Site Number 392072

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Saitama-Shi, Japan

Investigational Site Number 392006

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Sasebo-Shi, Japan

Investigational Site Number 392073

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Sapporo-Shi, Japan

Investigational Site Number 392022

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Sendai-Shi, Japan

Investigational Site Number 392021

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Sendai-Shi, Japan

Investigational Site Number 392033

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Sendai-Shi, Japan

Investigational Site Number 392100

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Sendai-Shi, Japan

Investigational Site Number 392029

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Shizuoka-Shi, Japan

Investigational Site Number 392023

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Takaoka-Shi, Japan

Investigational Site Number 392020

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Takasaki-Shi, Japan

Investigational Site Number 392088

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Takatsuki-Shi, Japan

Investigational Site Number 392003

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Tomakomai-Shi, Japan

Investigational Site Number 392018

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Tokorozawa-Shi, Japan

Investigational Site Number 392052

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Toshima-Ku, Japan

Investigational Site Number 392077

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Tonami-Shi, Japan

Investigational Site Number 392058

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Toyama-Shi, Japan

Investigational Site Number 392079

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Urayasu-Shi, Japan

Investigational Site Number 392055

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Toyonaka-Shi, Japan

Investigational Site Number 392074

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Urasoe-Shi, Japan

Investigational Site Number 392048

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Yokohama-Shi, Japan

Investigational Site Number 392090

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Yokohama-Shi, Japan

Investigational Site Number 392098

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Hiroshima-Shi, Japan

Investigational Site Number 392004

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Fukui-Shi, Japan

Investigational Site Number 392035

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Asahikawa-Shi, Japan

Investigational Site Number 392070

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Beppu-Shi, Japan

Investigational Site Number 392082

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Meguro-Ku, Japan

Investigational Site Number 392071

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Sendai-Shi, Japan

Investigational Site Number 392025

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Sumida-Ku, Japan

Investigational Site Number 392092

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Sumida-Ku, Japan

Investigational Site Number 392005

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Tomakomai-Shi, Japan

Investigational Site Number 392001

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Asahikawa-Shi, Japan

Investigational Site Number 392066

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Kamakura-Shi, Japan

Investigational Site Number 392089

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Kurashiki-Shi, Japan

Investigational Site Number 392026

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Matsuyama-Shi, Japan

Investigational Site Number 392081

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Matsuyama-Shi, Japan

Investigational Site Number 392056

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Nagoya-Shi, Japan

Investigational Site Number 392014

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Sapporo-Shi, Japan

Investigational Site Number 392095

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Takarazuka-Shi, Japan

Investigational Site Number 392038

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Fukuoka-Shi, Japan

Investigational Site Number 392054

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Funabashi-Shi, Japan

Investigational Site Number 392011

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Hitachinaka-Shi, Japan

Investigational Site Number 392032

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Nagano-Shi, Japan

Investigational Site Number 392043

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Nagoya-Shi, Japan

Investigational Site Number 392080

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Nagoya-Shi, Japan

Investigational Site Number 392075

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Sakai-Shi, Japan

Investigational Site Number 392068

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Sapporo-Shi, Japan

Investigational Site Number 392101

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Yokohama-Shi, Japan

Investigational Site Number 392045

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Kitakyushu-Shi, Japan

Investigational Site Number 392049

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Sagamihara-Shi, Japan

Investigational Site Number 392069

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Kumamoto-Shi, Japan

Investigational Site Number 392008

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Omura-Shi, Japan

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