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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1160-6525 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Sarilumab 150 mg q2w | Experimental | Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
|
| Sarilumab 200 mg q2w | Experimental | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarilumab | Drug | Pharmaceutical form:solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline up to Week 58 |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for potentially clinically significant ECG abnormalities:
| Baseline up to Week 58 |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at 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. |
Not provided
Inclusion criteria:
Diagnosis of rheumatoid arthritis (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:
For the combination stratum:
Participants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.
For the monotherapy stratum:
Participants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.
Exclusion criteria:
Participants <20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents 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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392010 | Asahi-Shi | Japan | ||||
| Investigational Site Number 392001 |
A total of 91 participants were randomized to receive monotherapy stratum (in a ratio of 1:1 to sarilumab 150 mg, once in every two weeks [q2w] or sarilumab 200 mg, q2w) or combination stratum (background non-methotrexate disease modifying anti-rheumatic drugs [Non-MTX DMARDs] along with sarilumab 150/ 200 mg q2w in 1:1 ratio).
This study was conducted at 40 centers in Japan. A total of 117 participants were screened between 23 February 2015 and 9 September 2015, 26 of whom were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sarilumab 150 mg q2w + DMARDs | Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks. |
| FG001 | Sarilumab 200 mg q2w + DMARDs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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|
| Sulfasalazine | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Leflunomide | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Bucillamine | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Tacrolimus | Drug | Pharmaceutical form: Capsule Route of administration: Oral |
|
| Mizoribine | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
Criteria for potentially clinically significant abnormalities:
|
| Baseline up to Week 58 |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters | Criteria for potentially clinically significant abnormalities:
| Baseline up to Week 58 |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes | Criteria for potentially clinically significant abnormalities:
| Baseline up to Week 58 |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters | Criteria for potentially clinically significant abnormalities:
| Baseline up to Week 58 |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters | Criteria for potentially clinically significant abnormalities:
| Baseline up to Week 58 |
| Week 52 |
| Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP) | 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. | Baseline, Week 52 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. | Baseline, Week 52 |
| Asahikawa-Shi |
| Japan |
| Investigational Site Number 392070 | Beppu-Shi | Japan |
| Investigational Site Number 392036 | Chiba | Japan |
| Investigational Site Number 392083 | Chūōku | Japan |
| Investigational Site Number 392004 | Fukui-shi | Japan |
| Investigational Site Number 392039 | Fukuoka | Japan |
| Investigational Site Number 392030 | Ichinomiya-Shi | Japan |
| Investigational Site Number 392002 | Iizuka-Shi | Japan |
| Investigational Site Number 392019 | Kagoshima | Japan |
| Investigational Site Number 392066 | Kamakura-Shi | Japan |
| Investigational Site Number 392050 | Kato-Shi | Japan |
| Investigational Site Number 392037 | Kawachi-Nagano-Shi | Japan |
| Investigational Site Number 392099 | Kawasaki-Shi | Japan |
| Investigational Site Number 392013 | Kitakyushu-Shi | Japan |
| Investigational Site Number 392097 | Kochi | Japan |
| Investigational Site Number 392065 | Kushiro | Japan |
| Investigational Site Number 392026 | Matsuyama | Japan |
| Investigational Site Number 392034 | Miyagi-Gun | Japan |
| Investigational Site Number 392076 | Nagoya | Japan |
| Investigational Site Number 392080 | Nagoya | Japan |
| Investigational Site Number 392046 | Narashino-Shi | Japan |
| Investigational Site Number 392062 | Okayama | Japan |
| Investigational Site Number 392027 | Osaki-Shi | Japan |
| Investigational Site Number 392059 | Ōita | Japan |
| Investigational Site Number 392049 | Sagamihara-Shi | Japan |
| Investigational Site Number 392014 | Sapporo | Japan |
| Investigational Site Number 392041 | Sapporo | Japan |
| Investigational Site Number 392073 | Sapporo | Japan |
| Investigational Site Number 392006 | Sasebo-Shi | Japan |
| Investigational Site Number 392021 | Sendai | Japan |
| Investigational Site Number 392022 | Sendai | Japan |
| Investigational Site Number 392033 | Sendai | Japan |
| Investigational Site Number 392071 | Sendai | Japan |
| Investigational Site Number 392029 | Shizuoka | Japan |
| Investigational Site Number 392023 | Takaoka-Shi | Japan |
| Investigational Site Number 392003 | Tomakomai-Shi | Japan |
| Investigational Site Number 392074 | Urasoe-Shi | Japan |
| Investigational Site Number 392079 | Urayasu-Shi | Japan |
| Investigational Site Number 392048 | Yokohama | Japan |
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
| FG002 | Sarilumab 150 mg q2w | Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
| FG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of investigational medicinal product (IMP), irrespective of compliance with the study protocol and procedures.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sarilumab 150 mg q2w + DMARDs | Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. |
| BG001 | Sarilumab 200 mg q2w + DMARDs | Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. |
| BG002 | Sarilumab 150 mg q2w | Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
| BG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | participants | Baseline up to Week 58 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities | Criteria for potentially clinically significant vital sign abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for potentially clinically significant ECG abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Criteria for potentially clinically significant abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at 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. | mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters | Criteria for potentially clinically significant abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes | Criteria for potentially clinically significant abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters | Criteria for potentially clinically significant abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters | Criteria for potentially clinically significant abnormalities:
| 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. | Posted | Number | participants | Baseline up to Week 58 |
|
All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration [up to Week 58]).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sarilumab 150 mg q2w + DMARDs | Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. | 0 | 15 | 0 | 15 | 14 | 15 |
| EG001 | Sarilumab 200 mg q2w + DMARDs | Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks. | 0 | 15 | 3 | 15 | 13 | 15 |
| EG002 | Sarilumab 150 mg q2w Monotherapy | Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. | 0 | 30 | 1 | 30 | 22 | 30 |
| EG003 | Sarilumab 200 mg q2w Monotherapy | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. | 0 | 31 | 2 | 31 | 23 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Periorbital abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Protein urine | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592401 | sarilumab |
| D012460 | Sulfasalazine |
| D000077339 | Leflunomide |
| C026535 | bucillamine |
| D016559 | Tacrolimus |
| C010052 | mizoribine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
| Male |
|
| SAE |
|
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
| OG002 | Sarilumab 150 mg q2w | Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
| OG002 | Sarilumab 150 mg q2w | Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
| Sarilumab 150 mg q2w |
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
| Sarilumab 200 mg q2w |
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|
| OG003 |
| Sarilumab 200 mg q2w |
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
|
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. |
| OG003 | Sarilumab 200 mg q2w | Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks. |
|
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