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)

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT02373202

Acronym / sponsor ID

LTS13618

Conditions

Rheumatoid Arthritis

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

91 participants (actual)

Lead sponsor

SanofiIndustry (pharma, biotech, devices)

Collaborators

Regeneron Pharmaceuticals

Study start

Feb 2015

Primary completion

Nov 2016 (actual)

Study completion

Nov 2016 (actual)

First posted

26 Feb 2015 (estimated)

Results

Posted 30 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

4

Who may qualify

Ages

20 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

   Time frame: Baseline up to Week 58

   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.

2. Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

   Time frame: Baseline up to Week 58

   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

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

   Time frame: Baseline up to Week 58

   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

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

   Time frame: Baseline 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)

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

   Time frame: Baseline up to Week 58

   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

6. Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes

   Time frame: Baseline 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

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

   Time frame: Baseline up to Week 58

   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

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

   Time frame: Baseline 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 * Unconjugated bilirubin: >1.5 ULN * ALT >3 ULN and TBILI >2 ULN * CBILI >35% TBILI and TBILI >1.5 ULN * Albumin: <=25 g/L

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

40 sites in 1 country: see every site and its status.