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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002988-18 | EudraCT Number | ||
| U1111-1200-2184 | Other Identifier | UTN |
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Protracted recruitment timeline exacerbated by COVID-19 pandemic
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.
Secondary Objective:
Study duration per participant was approximately 82 weeks, including an up to 6-week screening period, 52-week treatment period, and 24-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo+52 Week Taper | Experimental | Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. |
|
| Placebo+26 Week Taper | Experimental | Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
| Sarilumab 150mg q2w+26 Week Taper | Placebo Comparator | Participants received sarilumab 150 milligrams (mg) as SC injection q2w up to 52 weeks along with prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
| Sarilumab 200mg q2w+26 Week Taper | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarilumab SAR153191 | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. | At Week 52 |
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. |
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Inclusion criteria :
Exclusion criteria:
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 8400002 | Boca Raton | Florida | 33486 | United States | ||
| Investigational Site Number 8400017 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37840134 | Derived | Schmidt WA, Dasgupta B, Sloane J, Giannelou A, Xu Y, Unizony SH, Mackie SL, Gonzalez-Gay MA, Spiera R, Warrington KJ, Villiger PM, Nivens MC, Akinlade B, Lin Y, Buttgereit F, Stone JH. A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis. Arthritis Res Ther. 2023 Oct 16;25(1):199. doi: 10.1186/s13075-023-03177-6. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Participants were randomized to 4 treatments arms in 2:1:1:2 ratio by interactive response technology stratified by starting dose of prednisone at Baseline (less than [<] 30 milligrams per day (mg/day) or greater than or equal to [>=] 30 mg/day).
Study was conducted at 48 active centers in 19 countries. A total of 125 participants were screened between 20 November 2018 and 19 March 2020, of whom 42 participants were screen failures. Screen failures were mainly due to not meeting inclusion criteria. A total of 83 participants were enrolled and randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo+52 Week Taper | Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2018 | Nov 17, 2021 |
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Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
|
| Sarilumab matching placebo | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Prednisone | Drug | Pharmaceutical form: tablets or capsules Route of administration: oral administration |
|
| Prednisone matching placebo | Drug | Pharmaceutical form: capsules Route of administration: oral administration |
|
| Up to Week 12 |
| Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. | Up to Week 12 |
| Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set | Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported. | From Week 12 through Week 52 |
| Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population | Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported. | From Week 12 through Week 24 |
| Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set | Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. | From Week 12 through Week 52 |
| Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population | Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. | From Week 12 through Week 24 |
| Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set | Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA. | From Week 12 through Week 52 |
| Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population | Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA. | From Week 12 through Week 24 |
| Total Cumulative Corticosteroid (Including Prednisone) Dose | Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. | Up to Week 52 |
| Time to First Giant Cell Arteritis Disease Flare | Time to first GCA flare was defined as the duration (in days) from randomization to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. | Up to Week 52 |
| Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population | GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. | At Week 24 |
| Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52 | GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. | At Week 52 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the SC IMP +60 days). | From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60) |
| Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab | Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol. | Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52 |
| Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24 | Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay. | post-dose at Week 24 |
| Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response | ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorized as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000). | From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60) |
| Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 | ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour. | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 | CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body. | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 | Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. | Baseline, Weeks 2, 12, 24, and 52 |
| Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 | Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. | Baseline, Weeks 2, 12, 24, and 52 |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Investigational Site Number 8400014 | Iowa City | Iowa | 52242 | United States |
| Investigational Site Number 8400018 | Portland | Oregon | 97239 | United States |
| Investigational Site Number 8400019 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number 8400011 | Dallas | Texas | 75231 | United States |
| Investigational Site Number 0320001 | Buenos Aires | C1015ABO | Argentina |
| Investigational Site Number 0320002 | Caba | C1181ACH | Argentina |
| Investigational Site Number 0360003 | Camberwell | 3124 | Australia |
| Investigational Site Number 0360006 | Clayton | 3168 | Australia |
| Investigational Site Number 0360001 | Kogarah | 2217 | Australia |
| Investigational Site Number 0560001 | Leuven | 3000 | Belgium |
| Investigational Site Number 1240007 | Hamilton | L8N 4A6 | Canada |
| Investigational Site Number 1240010 | Montreal | H4A 3T2 | Canada |
| Investigational Site Number 1240001 | Rimouski | G5L 5T1 | Canada |
| Investigational Site Number 1240005 | Sherbrooke | J1G 2E8 | Canada |
| Investigational Site Number 1240003 | Trois-Rivières | G8Z 1Y2 | Canada |
| Investigational Site Number 1910001 | Zagreb | 10000 | Croatia |
| Investigational Site Number 2080002 | Aarhus C | 8000 | Denmark |
| Investigational Site Number 2080003 | Svendborg | 5700 | Denmark |
| Investigational Site Number 2330001 | Tallinn | 13419 | Estonia |
| Investigational Site Number 2500005 | Brest | 29609 | France |
| Investigational Site Number 2500002 | Montivilliers | 76290 | France |
| Investigational Site Number 2500003 | Montpellier | 34295 | France |
| Investigational Site Number 2500007 | Mulhouse | 68100 | France |
| Investigational Site Number 2500001 | Paris | 75014 | France |
| Investigational Site Number 2500006 | Pessac | 33604 | France |
| Investigational Site Number 2760001 | Berlin | 13125 | Germany |
| Investigational Site Number 2760002 | Dresden | 01307 | Germany |
| Investigational Site Number 2760003 | Kirchheim unter Teck | 73230 | Germany |
| Investigational Site Number 2760004 | München | 80336 | Germany |
| Investigational Site Number 2760007 | Tübingen | 72076 | Germany |
| Investigational Site Number 3480001 | Debrecen | 4032 | Hungary |
| Investigational Site Number 3760006 | Ashkelon | 78278 | Israel |
| Investigational Site Number 3760004 | Haifa | 34362 | Israel |
| Investigational Site Number 3800001 | Milan | 20132 | Italy |
| Investigational Site Number 3800005 | Rozzano | 20089 | Italy |
| Investigational Site Number 5280005 | Leeuwarden | 8934 AD | Netherlands |
| Investigational Site Number 5280009 | Sittard-Geleen | 6162 BG | Netherlands |
| Investigational Site Number 5280007 | The Hague | 2545 CH | Netherlands |
| Investigational Site Number 5280001 | Venlo | 5912 BL | Netherlands |
| Investigational Site Number 6200001 | Almada | 2801-951 | Portugal |
| Investigational Site Number 6200005 | Aveiro | 3810-501 | Portugal |
| Investigational Site Number 6200004 | Ponte de Lima | 4990-041 | Portugal |
| Investigational Site Number 6430005 | Kemerovo | 650000 | Russia |
| Investigational Site Number 6430002 | Moscow | 115404 | Russia |
| Investigational Site Number 6430003 | Moscow | 123182 | Russia |
| Investigational Site Number 7050001 | Ljubljana | 1000 | Slovenia |
| Investigational Site Number 7240011 | A Coruña | 15006 | Spain |
| Investigational Site Number 7240010 | Bilbao | 48013 | Spain |
| Investigational Site Number 7240014 | Madrid | 28046 | Spain |
| Investigational Site Number 7240016 | Sabadell | 08208 | Spain |
| Investigational Site Number 7240015 | Santa Cruz de Tenerife | 38320 | Spain |
| Investigational Site Number 7520003 | Örebro | 701 85 | Sweden |
| Investigational Site Number 7520001 | Uppsala | 751 85 | Sweden |
| Investigational Site Number 7560002 | Sankt Gallen | 9007 | Switzerland |
| Investigational Site Number 8260006 | Aberdeen | AB25 2ZN | United Kingdom |
| Investigational Site Number 8260004 | Gateshead | NE9 6SX | United Kingdom |
| Investigational Site Number 8260003 | Leeds | LS7 4SA | United Kingdom |
| Investigational Site Number 8260005 | Manchester | M13 9WL | United Kingdom |
| Investigational Site Number 8260011 | Portsmouth | PO6 3LY | United Kingdom |
| FG001 |
| Placebo+26 Week Taper |
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| FG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| FG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| Week 52 Analysis Set Population | Randomized participants who had opportunity to complete the 52-week treatment period (randomized prior to October 16th, 2019). |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on randomized population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo+52 Week Taper | Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. |
| BG001 | Placebo+26 Week Taper | Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| BG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| BG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| BG004 | Total Title |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. | Analysis was performed on Week 52 analysis set population that included randomized participants who had opportunity to complete the 52-week treatment period (randomized prior to October 16th, 2019). | Posted | Number | percentage of participants | At Week 52 |
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| Primary | Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24. | Analysis was performed on intent-to-treat (ITT) population that included participants who were allocated to a randomized treatment regardless of whether the treatment kit was used, and were analyzed according to the treatment group allocated by randomization. | Posted | Number | percentage of participants | At Week 24 |
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| Secondary | Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. | Analysis was performed on Week 52 analysis set. | Posted | Count of Participants | Participants | Up to Week 12 |
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| Secondary | Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. | Analysis was performed on ITT population. | Posted | Count of Participants | Participants | Up to Week 12 |
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| Secondary | Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set | Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported. | Analysis was performed on Week 52 analysis set. | Posted | Count of Participants | Participants | From Week 12 through Week 52 |
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| Secondary | Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population | Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported. | Analysis was performed on ITT population. | Posted | Count of Participants | Participants | From Week 12 through Week 24 |
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| Secondary | Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set | Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. | Analysis was performed on Week 52 analysis set. | Posted | Count of Participants | Participants | From Week 12 through Week 52 |
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| Secondary | Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population | Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. | Analysis was performed on ITT population. | Posted | Count of Participants | Participants | From Week 12 through Week 24 |
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| Secondary | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set | Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA. | Analysis was performed on Week 52 analysis set. | Posted | Count of Participants | Participants | From Week 12 through Week 52 |
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| Secondary | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population | Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA. | Analysis was performed on ITT population. | Posted | Count of Participants | Participants | From Week 12 through Week 24 |
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| Secondary | Total Cumulative Corticosteroid (Including Prednisone) Dose | Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. | Analysis was performed on ITT population. | Posted | Mean | Standard Deviation | milligrams | Up to Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Giant Cell Arteritis Disease Flare | Time to first GCA flare was defined as the duration (in days) from randomization to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. | Analysis was performed on ITT population. | Posted | Median | 95% Confidence Interval | days | Up to Week 52 |
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| Secondary | Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population | GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. | Analysis was performed on ITT population. | Posted | Mean | Standard Deviation | units on a scale | At Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52 | GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. | Analysis was performed on Week 52 analysis set. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | At Week 52 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the SC IMP +60 days). | Analysis was performed on safety population that included participants who had received at least one dose or part of a dose of IMP and were analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60) |
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| Secondary | Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab | Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol. | Analyzed on PK analysis population: participants who had received at least one dose or part of a dose of IMP, were analyzed according to the treatment actually received and had at least 1 post-dose non-missing serum sarilumab concentration value. Here, 'Number Analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | nanograms per milliliter | Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52 |
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| Secondary | Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24 | Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay. | Analysis was performed on PK analysis population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol. | Posted | Mean | Standard Deviation | nanograms per milliliter | post-dose at Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response | ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorized as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000). | Analysis was performed on ADA population that included participants who had received at least one dose or part of a dose of IMP, were analyzed according to the treatment actually received and had at least 1 non-missing ADA result in the ADA assay following the first dose of IMP. | Posted | Number | percentage of participants | From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60) |
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| Secondary | Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 | ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour. | Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | millimeters per hour | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 | CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body. | Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | milligrams per liter | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 | Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. | Analysis was performed on safety population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | nanograms per Liter | Baseline, Weeks 2, 12, 24, and 52 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 | Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. | Analyzed on safety population. Here, 'Number Analyzed'=participants with available data for each specified category and '0' in number analyzed field signifies that no participants were available for assessments at specified time points in the respective arm. | Posted | Mean | Standard Deviation | nanograms per milliliter | Baseline, Weeks 2, 12, 24, and 52 |
|
From first dose (i.e., Day 1) of study drug to last dose date of study drug + 60 days (i.e., up to Week 60)
Reported AEs and deaths were treatment emergent AEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
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 | Placebo+52 Week Taper | Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. | 0 | 28 | 2 | 28 | 22 | 28 |
| EG001 | Placebo+26 Week Taper | Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | 1 | 14 | 3 | 14 | 13 | 14 |
| EG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | 0 | 14 | 2 | 14 | 13 | 14 |
| EG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | 2 | 27 | 7 | 27 | 20 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Blindness Unilateral | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Retinal Artery Occlusion | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Cerebral Amyloid Angiopathy | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Aortic Dissection | Vascular disorders | MedDRA23.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA23.1 | Systematic Assessment |
| |
| Peripheral Vascular Disorder | Vascular disorders | MedDRA23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Tendency To Bruise | Blood and lymphatic system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA23.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA23.1 | Systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA23.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA23.1 | Systematic Assessment |
| |
| Amaurosis Fugax | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Cataract Subcapsular | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Conjunctivitis Allergic | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Refraction Disorder | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA23.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Injection Site Pruritus | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Injection Site Rash | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Vessel Puncture Site Phlebitis | General disorders | MedDRA23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA23.1 | Systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Post-Traumatic Pain | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Stress Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Vaccination Complication | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
| |
| Creatinine Renal Clearance Decreased | Investigations | MedDRA23.1 | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA23.1 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA23.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA23.1 | Systematic Assessment |
| |
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA23.1 | Systematic Assessment |
| |
| Steroid Diabetes | Metabolism and nutrition disorders | MedDRA23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Burning Sensation | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Decreased Vibratory Sense | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA23.1 | Systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | MedDRA23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA23.1 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA23.1 | Systematic Assessment |
| |
| Uterine Polyp | Reproductive system and breast disorders | MedDRA23.1 | Systematic Assessment |
| |
| Allergic Cough | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA23.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Skin Atrophy | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Skin Discharge | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Skin Fragility | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Skin Striae | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA23.1 | Systematic Assessment |
| |
| Hypertensive Emergency | Vascular disorders | MedDRA23.1 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA23.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA23.1 | Systematic Assessment |
|
Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2021 | Nov 17, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592401 | sarilumab |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| Sarilumab 150mg q2w+26 Week Taper |
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| Sarilumab 150mg q2w+26 Week Taper |
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 |
| Sarilumab 150mg q2w+26 Week Taper |
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| Placebo+26 Week Taper |
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG001 |
| Placebo+26 Week Taper |
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| Placebo+26 Week Taper |
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| Sarilumab 150mg q2w+26 Week Taper |
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
|
|
| OG002 | Sarilumab 150mg q2w+26 Week Taper | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
| OG003 | Sarilumab 200mg q2w+26 Week Taper | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
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