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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002790-22 | |||
| U1111-1143-4344 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarilumab 150 mg q2w | Experimental | Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks. |
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| Sarilumab 200 mg q2w | Experimental | Sarilumab 200 mg SC injection q2w for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sarilumab SAR153191 (REGN88) | Drug | Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Incidence of Antidrug Antibodies (ADA) | ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30. | From Baseline to Week 30 [End of study (EOS)] |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Sarilumab Concentration | Trough Concentration (Ctrough). | Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30 |
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Inclusion criteria:
Exclusion criteria:
The above information is 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 840072 | Gilbert | Arizona | 85234 | United States | ||
| Investigational Site Number 840049 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31090044 | Derived | Wells AF, Parrino J, Mangan EK, Paccaly A, Lin Y, Xu C, Fan C, Graham NMH, van Hoogstraten H, Torri A. Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs. Rheumatol Ther. 2019 Sep;6(3):339-352. doi: 10.1007/s40744-019-0157-3. Epub 2019 May 14. |
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Of 201 participants, 69 participants were screen failures due to exclusion criteria met and inclusion criteria not met. 132 participants were randomized in 1:1 ratio to either sarilumab 150 mg every two weeks (q2w) or sarilumab 200 mg q2w.
The study was conducted at 27 centers in 7 countries. A total of 201 participants were screened between 03 June 2014 and 20 October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sarilumab 150 mg q2w | Sarilumab 150 mg subcutaneous (SC) injection q2w for 24 weeks |
| FG001 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection q2w for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Upland |
| California |
| 91786 |
| United States |
| Investigational Site Number 840220 | South Miami | Florida | 33143 | United States |
| Investigational Site Number 840230 | Elizabethtown | Kentucky | 42701 | United States |
| Investigational Site Number 840233 | Minot | North Dakota | 58701 | United States |
| Investigational Site Number 840127 | Oklahoma City | Oklahoma | 73103 | United States |
| Investigational Site Number 840011 | Tulsa | Oklahoma | 74104 | United States |
| Investigational Site Number 840009 | Duncansville | Pennsylvania | 16635 | United States |
| Investigational Site Number 840025 | Jackson | Tennessee | 38305 | United States |
| Investigational Site Number 840032 | Amarillo | Texas | 79124 | United States |
| Investigational Site Number 840074 | Mesquite | Texas | 75150 | United States |
| Investigational Site Number 840124 | Clarksburg | West Virginia | 26301 | United States |
| Investigational Site Number 840231 | Franklin | Wisconsin | 53132 | United States |
| Investigational Site Number 152002 | Santiago | 7501126 | Chile |
| Investigational Site Number 203034 | Pardubice | 53002 | Czechia |
| Investigational Site Number 203001 | Prague | 12850 | Czechia |
| Investigational Site Number 203002 | Uherské Hradiště | 686 01 | Czechia |
| Investigational Site Number 233010 | Tallinn | 10138 | Estonia |
| Investigational Site Number 233002 | Tallinn | 13419 | Estonia |
| Investigational Site Number 348014 | Budapest | 1027 | Hungary |
| Investigational Site Number 348025 | Budapest | 1027 | Hungary |
| Investigational Site Number 348021 | Esztergom | 2500 | Hungary |
| Investigational Site Number 616018 | Poznan | 61-397 | Poland |
| Investigational Site Number 616031 | Warsaw | 01-518 | Poland |
| Investigational Site Number 616012 | Wroclaw | 50-044 | Poland |
| Investigational Site Number 643006 | Kemerovo | 650000 | Russia |
| Investigational Site Number 643001 | Moscow | 115522 | Russia |
| Investigational Site Number 643016 | Ryazan | 390026 | Russia |
| COMPLETED |
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| NOT COMPLETED |
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Randomized population that included any participant who signed an informed consent and was allocated to a randomized treatment regardless of whether the treatment kit was used or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sarilumab 150 mg q2w | Sarilumab 150 mg SC injection q2w for 24 weeks. |
| BG001 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection q2w for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Percentage of Participants With Incidence of Antidrug Antibodies (ADA) | ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30. | Analysis was performed on immunogenicity population included all randomized participants who received at least one dose of sarilumab with at least one post-dose, evaluable ADA sample. | Posted | Number | Percentage of participants | From Baseline to Week 30 [End of study (EOS)] |
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| Secondary | Serum Sarilumab Concentration | Trough Concentration (Ctrough). | Analysis was performed on pharmacokinetic (PK) population consisted of all randomized population actually received at least one or partial dose of IMP, with at least one post-dose, non-missing serum sarilumab concentration. Number of participants analyzed=participants with serum sarilumab concentration assessment at specified time-points. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30 |
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All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the time from the first dose of IMP to last dose of IMP + 60 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sarilumab 150mg q2w | Sarilumab 150 mg SC injection q2w for 24 weeks. | 1 | 65 | 16 | 65 | ||
| EG001 | Sarilumab 200mg q2w | Sarilumab 200 mg SC injection q2w for 24 weeks. | 2 | 67 | 23 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| C000592401 | sarilumab |
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| Male |
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| Persistent neutralizing positive |
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