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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03600805
Registration number
NCT03600805
Ethics application status
Date submitted
17/07/2018
Date registered
26/07/2018
Titles & IDs
Public title
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
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Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis
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Secondary ID [1]
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0
2017-002988-18
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Secondary ID [2]
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EFC15068
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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0
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Other neurological disorders
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sarilumab SAR153191
Treatment: Drugs - Sarilumab matching placebo
Treatment: Drugs - Prednisone
Treatment: Drugs - Prednisone matching placebo
Experimental: 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.
Experimental: 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.
Placebo comparator: Sarilumab 150mg q2w+26 Week Taper - 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.
Placebo comparator: Sarilumab 200mg q2w+26 Week Taper - 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.
Treatment: Drugs: Sarilumab SAR153191
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Treatment: Drugs: Sarilumab matching placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Treatment: Drugs: Prednisone
Pharmaceutical form: tablets or capsules Route of administration: oral administration
Treatment: Drugs: Prednisone matching placebo
Pharmaceutical form: capsules Route of administration: oral administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved Sustained Disease Remission at Week 52
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Assessment method [1]
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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.
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Timepoint [1]
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At Week 52
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Primary outcome [2]
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Percentage of Participants Who Achieved Sustained Disease Remission at Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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At Week 24
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Secondary outcome [1]
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Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set
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Assessment method [1]
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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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Timepoint [1]
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Up to Week 12
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Secondary outcome [2]
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Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Week 12
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Secondary outcome [3]
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Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set
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Assessment method [3]
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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.
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Timepoint [3]
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From Week 12 through Week 52
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Secondary outcome [4]
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Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population
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Assessment method [4]
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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.
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Timepoint [4]
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From Week 12 through Week 24
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Secondary outcome [5]
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Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set
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Assessment method [5]
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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.
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Timepoint [5]
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From Week 12 through Week 52
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Secondary outcome [6]
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Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population
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Assessment method [6]
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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.
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Timepoint [6]
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From Week 12 through Week 24
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Secondary outcome [7]
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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set
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Assessment method [7]
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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.
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Timepoint [7]
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From Week 12 through Week 52
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Secondary outcome [8]
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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population
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Assessment method [8]
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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.
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Timepoint [8]
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From Week 12 through Week 24
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Secondary outcome [9]
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Total Cumulative Corticosteroid (Including Prednisone) Dose
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Assessment method [9]
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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.
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Timepoint [9]
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Up to Week 52
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Secondary outcome [10]
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Time to First Giant Cell Arteritis Disease Flare
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Assessment method [10]
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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.
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Timepoint [10]
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Up to Week 52
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Secondary outcome [11]
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Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population
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Assessment method [11]
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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.
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Timepoint [11]
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At Week 24
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Secondary outcome [12]
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Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52
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Assessment method [12]
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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.
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Timepoint [12]
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At Week 52
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Secondary outcome [13]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [13]
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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).
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Timepoint [13]
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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 outcome [14]
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Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab
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Assessment method [14]
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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.
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Timepoint [14]
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Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52
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Secondary outcome [15]
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Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
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Assessment method [15]
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Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.
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Timepoint [15]
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post-dose at Week 24
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Secondary outcome [16]
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Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response
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Assessment method [16]
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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).
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Timepoint [16]
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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 outcome [17]
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Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
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Secondary outcome [18]
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Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
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Assessment method [18]
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CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body.
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Timepoint [18]
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Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
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Secondary outcome [19]
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Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline, Weeks 2, 12, 24, and 52
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Secondary outcome [20]
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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline, Weeks 2, 12, 24, and 52
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Eligibility
Key inclusion criteria
Inclusion criteria :
* Diagnosis of GCA according to European League Against Rheumatism/American College of Rheumatology classification criteria.
* New onset active disease or refractory active disease.
* At least one of the symptoms of GCA within 6 weeks of baseline.
* Either erythrocyte sedimentation rate greater than or equal to (>=) 30 millimeter per hour or C-reactive protein >=10 mg per liter within 6 weeks of baseline.
* Received or were able to receive prednisone 20-60 mg/day for the treatment of active GCA.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
* Major ischemic event, unrelated to GCA, within 12 weeks of screening.
* Any prior use of the following therapies, for the treatment of GCA:
* Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
* Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
* Abatacept within 8 weeks of baseline.
* Anakinra within 1 week of baseline.
* Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives had elapsed prior to baseline, whichever was longer.
* Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological Interleukin 6 (IL-6) IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline was not exclusionary).
* Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
* Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine, mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and had been stable for at least 3 months prior to baseline was not exclusionary).
* Concurrent use of systemic CS for conditions other than GCA.
* Use of intervascular CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
* Pregnant or breastfeeding woman.
* Participants with active or untreated latent tuberculosis.
* Participants with history of invasive opportunistic infections.
* Participants with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
* Participants with uncontrolled diabetes mellitus.
* Participants with non-healed or healing skin ulcers.
* Participants who received any live, attenuated vaccine within 3 months of baseline.
* Participants who are positive for hepatitis B, hepatitis C and/or HIV.
* Participants with a history of active or recurrent herpes zoster.
* Participants with a history of or prior articular or prosthetic joint infection.
* Prior or current history of malignancy.
* Participants who have had surgery within 4 weeks of screening or planned surgery during study.
* Participants with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation..
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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/11/2020
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Sample size
Target
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 0360003 - Camberwell
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Recruitment hospital [2]
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Investigational Site Number 0360006 - Clayton
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Recruitment hospital [3]
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Investigational Site Number 0360001 - Kogarah
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Recruitment postcode(s) [1]
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0
3124 - Camberwell
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Florida
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Iowa
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Oregon
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Pennsylvania
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Country [6]
0
0
Argentina
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State/province [6]
0
0
Buenos Aires
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Country [7]
0
0
Argentina
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State/province [7]
0
0
Caba
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Leuven
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Country [9]
0
0
Canada
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State/province [9]
0
0
Hamilton
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Country [10]
0
0
Canada
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State/province [10]
0
0
Montreal
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Country [11]
0
0
Canada
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State/province [11]
0
0
Rimouski
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Country [12]
0
0
Canada
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State/province [12]
0
0
Sherbrooke
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Country [13]
0
0
Canada
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State/province [13]
0
0
Trois-Rivières
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Country [14]
0
0
Croatia
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State/province [14]
0
0
Zagreb
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Country [15]
0
0
Denmark
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State/province [15]
0
0
Aarhus C
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Country [16]
0
0
Denmark
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State/province [16]
0
0
Svendborg
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Country [17]
0
0
Estonia
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State/province [17]
0
0
Tallinn
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Country [18]
0
0
France
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State/province [18]
0
0
Brest Cedex
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Country [19]
0
0
France
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State/province [19]
0
0
Montivilliers
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Country [20]
0
0
France
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State/province [20]
0
0
Montpellier
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Country [21]
0
0
France
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State/province [21]
0
0
Mulhouse
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Country [22]
0
0
France
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State/province [22]
0
0
Paris
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Country [23]
0
0
France
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State/province [23]
0
0
Pessac
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Country [24]
0
0
Germany
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State/province [24]
0
0
Berlin
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Country [25]
0
0
Germany
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State/province [25]
0
0
Dresden
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Country [26]
0
0
Germany
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State/province [26]
0
0
Kirchheim Unter Teck
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Country [27]
0
0
Germany
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State/province [27]
0
0
München
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Country [28]
0
0
Germany
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State/province [28]
0
0
Tübingen
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Country [29]
0
0
Hungary
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State/province [29]
0
0
Debrecen
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Country [30]
0
0
Israel
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State/province [30]
0
0
Ashkelon
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Country [31]
0
0
Israel
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State/province [31]
0
0
Haifa
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Italy
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Milano
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Italy
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Rozzano
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Netherlands
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Den Haag
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Netherlands
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Leeuwarden
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Netherlands
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Sittard-Geleen
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Venlo
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Portugal
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Almada
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Portugal
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Aveiro
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Portugal
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Ponte De Lima
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Slovenia
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Ljubljana
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Spain
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Bilbao
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Spain
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La Coruña
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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Santa Cruz De Tenerife
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Sweden
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Uppsala
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Sweden
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Örebro
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Switzerland
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St. Gallen
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United Kingdom
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Aberdeen
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United Kingdom
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Gateshead
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United Kingdom
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Leeds
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United Kingdom
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Manchester
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United Kingdom
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Commercial sector/industry
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Regeneron Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
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: * To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: * Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. * Cumulative CS (including prednisone) exposure. * To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. * To measure sarilumab serum concentrations in participants with GCA. * To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
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Trial website
https://clinicaltrials.gov/study/NCT03600805
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/05/NCT03600805/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/05/NCT03600805/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03600805