Trial · NCT02373202
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)
NCT02373202, Phase 3, Completed, Sanofi; results first posted 2018-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT02373202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02373202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT02373202
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Rheumatoid Arthritis
- Interventions
- Sarilumab, Sulfasalazine, Leflunomide, Bucillamine, Tacrolimus, Mizoribine
- First posted
- 2015-02-26
- Last updated
- 2018-01-30
- Results first posted
- 2018-01-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. |
| Primary | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities | 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 |
| Primary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | 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 |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | 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) |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters | 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 |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes | 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 |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters | 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 |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters | 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 |
| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52 | Week 52 | 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 Question-Disability Index \[HAQ-DI\], with scoring range of 0 \[better health\] - 3 \[worst health\]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively. |
| Secondary | Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP) | Baseline, Week 52 | DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant's assessment of general health on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52 | Week 52 | mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP) | Baseline, Week 52 | mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 | Baseline, Week 52 | mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters | Baseline up to Week 58 | Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group408
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 150 mg q2w + DMARDs | Any TEAE | 14 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 200 mg q2w + DMARDs | Any TEAE | 13 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 150 mg q2w | Any TEAE | 25 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 200 mg q2w | Any TEAE | 28 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 150 mg q2w + DMARDs | SAE | 0 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 200 mg q2w + DMARDs | SAE | 3 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 150 mg q2w | SAE | 1 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Sarilumab 200 mg q2w | SAE | 2 | participants | |
| Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities | Sarilumab 150 mg q2w + DMARDs | SBP (supine) <=95 mmHg and DFB >=20 mmHg | 0 | participants | |
| Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities | Sarilumab 200 mg q2w + DMARDs | SBP (supine) <=95 mmHg and DFB >=20 mmHg | 0 | participants |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sarilumab 150 mg q2w + DMARDs | 15 | |
| Overall Study | STARTED | Sarilumab 200 mg q2w + DMARDs | 15 | |
| Overall Study | STARTED | Sarilumab 150 mg q2w | 30 | |
| Overall Study | STARTED | Sarilumab 200 mg q2w | 31 | |
| Overall Study | COMPLETED | Sarilumab 150 mg q2w + DMARDs | 13 | |
| Overall Study | COMPLETED | Sarilumab 200 mg q2w + DMARDs | 9 | |
| Overall Study | COMPLETED | Sarilumab 150 mg q2w | 27 | |
| Overall Study | COMPLETED | Sarilumab 200 mg q2w | 30 | |
| Overall Study | NOT COMPLETED | Sarilumab 150 mg q2w + DMARDs | 2 | |
| Overall Study | NOT COMPLETED | Sarilumab 200 mg q2w + DMARDs | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events296
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 150 mg q2w + DMARDs | 5 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 200 mg q2w + DMARDs | 3 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 150 mg q2w Monotherapy | 1 | 30 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 200 mg q2w Monotherapy | 3 | 31 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sarilumab 150 mg q2w + DMARDs | 1 | 15 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sarilumab 200 mg q2w + DMARDs | 1 | 15 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sarilumab 150 mg q2w Monotherapy | 0 | 30 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sarilumab 200 mg q2w Monotherapy | 1 | 31 | |
| other | Conjunctivitis allergic | Eye disorders | Sarilumab 150 mg q2w + DMARDs | 0 | 15 | |
| other | Conjunctivitis allergic | Eye disorders | Sarilumab 200 mg q2w + DMARDs | 0 | 15 |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sarilumab 150 mg q2w + DMARDs | 0 | 15 |
| Total, all-cause mortality | Sarilumab 200 mg q2w + DMARDs | 0 | 15 |
| Total, all-cause mortality | Sarilumab 150 mg q2w Monotherapy | 0 | 30 |
| Total, all-cause mortality | Sarilumab 200 mg q2w Monotherapy | 0 | 31 |
| Total, other adverse events | Sarilumab 150 mg q2w + DMARDs | 14 | 15 |
| Total, other adverse events | Sarilumab 200 mg q2w + DMARDs | 13 | 15 |
| Total, other adverse events | Sarilumab 150 mg q2w Monotherapy | 22 | 30 |
| Total, other adverse events | Sarilumab 200 mg q2w Monotherapy | 23 | 31 |
| Total, serious adverse events | Sarilumab 150 mg q2w + DMARDs | 0 | 15 |
| Total, serious adverse events | Sarilumab 200 mg q2w + DMARDs | 3 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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