NCT02373202|CompletedPhase 3ResultsFDA Drug

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis

Sanofi ClinicalTrials.gov

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2 other identifiers

LTS13618U1111-1160-6525

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2015

StartedFeb 2015

CompletionNov 2016

Brief Summary

Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline

Completed

Started Feb 2015

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach

1 country

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

February 1, 2015

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed

14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2018

Completed

Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

February 12, 2015

Results QC Date

November 2, 2017

Last Update Submit

January 5, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (8)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.
Baseline up to Week 58
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
Criteria for potentially clinically significant vital sign abnormalities: * Systolic blood pressure (SBP) supine: \<=95 mmHg and decrease from baseline (DFB) \>=20 mmHg; \>=160 mmHg and increase from baseline (IFB) \>=20 mmHg * Diastolic blood pressure (DBP) supine: \<=45 mmHg and DFB \>=10 mmHg; \>=110 mmHg and IFB ≥10 mmHg * SBP (Orthostatic): \<=-20 mmHg * DBP (Orthostatic): \<=-10 mmHg * Heart rate (HR) supine: \<=50 beats per minute (bpm) and DFB \>=20 bpm; \>=120 bpm and IFB \>=20 bpm * Weight: \>=5% DFB; \>=5% IFB
Baseline up to Week 58
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Criteria for potentially clinically significant ECG abnormalities: * PR Interval: \>200 milliseconds (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
Baseline up to Week 58
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)
Baseline up to Week 58
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 \[unfas\]) or \>=7 mmol/L (fasted \[fas\]) * 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
Baseline up to Week 58
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
Baseline up to Week 58
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Criteria for potentially clinically significant abnormalities: * Creatinine: \>=150 micromol/L (adults); \>=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
Baseline up to Week 58
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 * Unconjugated bilirubin: \>1.5 ULN * ALT \>3 ULN and TBILI \>2 ULN * CBILI \>35% TBILI and TBILI \>1.5 ULN * Albumin: \<=25 g/L
Baseline up to Week 58

Secondary Outcomes (3)

Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52
Week 52
Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)
Baseline, Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
Baseline, Week 52

Study Arms (4)

Sarilumab 150 mg q2w + DMARDs

EXPERIMENTAL

Participants received sarilumab 150 mg, subcutaneous (SC) injection, once every two weeks (q2w) along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks.

Drug: SarilumabDrug: SulfasalazineDrug: LeflunomideDrug: BucillamineDrug: TacrolimusDrug: Mizoribine

Sarilumab 200 mg q2w + DMARDs

EXPERIMENTAL

Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks.

Drug: SarilumabDrug: SulfasalazineDrug: LeflunomideDrug: BucillamineDrug: TacrolimusDrug: Mizoribine

Sarilumab 150 mg q2w

EXPERIMENTAL

Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.

Drug: Sarilumab

Sarilumab 200 mg q2w

EXPERIMENTAL

Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.

Drug: Sarilumab

Interventions

SarilumabDRUG

Pharmaceutical form:solution

Also known as: SAR153191 (REGN88)

Sarilumab 150 mg q2wSarilumab 150 mg q2w + DMARDsSarilumab 200 mg q2wSarilumab 200 mg q2w + DMARDs

SulfasalazineDRUG

Pharmaceutical form: Tablet Route of administration: Oral