Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

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).

Study Overview

• Status: Terminated
• Conditions: Giant Cell Arteritis
• Intervention / Treatment: Drug: Sarilumab matching placebo; Drug: Prednisone; Drug: Prednisone matching placebo; Drug: Sarilumab SAR153191

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Investigational Site Number 0320001
  • Caba, Argentina, C1181ACH
    • Investigational Site Number 0320002
• Australia
  • Camberwell, Australia, 3124
    • Investigational Site Number 0360003
  • Clayton, Australia, 3168
    • Investigational Site Number 0360006
  • Kogarah, Australia, 2217
    • Investigational Site Number 0360001
• Belgium
  • Leuven, Belgium, 3000
    • Investigational Site Number 0560001
• Canada
  • Hamilton, Canada, L8N 4A6
    • Investigational Site Number 1240007
  • Montreal, Canada, H4A 3T2
    • Investigational Site Number 1240010
  • Rimouski, Canada, G5L 5T1
    • Investigational Site Number 1240001
  • Sherbrooke, Canada, J1G 2E8
    • Investigational Site Number 1240005
  • Trois-Rivières, Canada, G8Z 1Y2
    • Investigational Site Number 1240003
• Croatia
  • Zagreb, Croatia, 10000
    • Investigational Site Number 1910001
• Denmark
  • Aarhus C, Denmark, 8000
    • Investigational Site Number 2080002
  • Svendborg, Denmark, 5700
    • Investigational Site Number 2080003
• Estonia
  • Tallinn, Estonia, 13419
    • Investigational Site Number 2330001
• France
  • Brest Cedex, France, 29609
    • Investigational Site Number 2500005
  • Montivilliers, France, 76290
    • Investigational Site Number 2500002
  • Montpellier, France, 34295
    • Investigational Site Number 2500003
  • Mulhouse, France, 68100
    • Investigational Site Number 2500007
  • Paris, France, 75014
    • Investigational Site Number 2500001
  • Pessac, France, 33604
    • Investigational Site Number 2500006
• Germany
  • Berlin, Germany, 13125
    • Investigational Site Number 2760001
  • Dresden, Germany, 01307
    • Investigational Site Number 2760002
  • Kirchheim Unter Teck, Germany, 73230
    • Investigational Site Number 2760003
  • München, Germany, 80336
    • Investigational Site Number 2760004
  • Tübingen, Germany, 72076
    • Investigational Site Number 2760007
• Hungary
  • Debrecen, Hungary, 4032
    • Investigational Site Number 3480001
• Israel
  • Ashkelon, Israel, 78278
    • Investigational Site Number 3760006
  • Haifa, Israel, 34362
    • Investigational Site Number 3760004
• Italy
  • Milano, Italy, 20132
    • Investigational Site Number 3800001
  • Rozzano, Italy, 20089
    • Investigational Site Number 3800005
• Netherlands
  • Den Haag, Netherlands, 2545 CH
    • Investigational Site Number 5280007
  • Leeuwarden, Netherlands, 8934 AD
    • Investigational Site Number 5280005
  • Sittard-Geleen, Netherlands, 6162 BG
    • Investigational Site Number 5280009
  • Venlo, Netherlands, 5912 BL
    • Investigational Site Number 5280001
• Portugal
  • Almada, Portugal, 2801-951
    • Investigational Site Number 6200001
  • Aveiro, Portugal, 3810-501
    • Investigational Site Number 6200005
  • Ponte De Lima, Portugal, 4990-041
    • Investigational Site Number 6200004
• Russian Federation
  • Kemerovo, Russian Federation, 650000
    • Investigational Site Number 6430005
  • Moscow, Russian Federation, 115404
    • Investigational Site Number 6430002
  • Moscow, Russian Federation, 123182
    • Investigational Site Number 6430003
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Investigational Site Number 7050001
• Spain
  • Bilbao, Spain, 48013
    • Investigational Site Number 7240010
  • La Coruña, Spain, 15006
    • Investigational Site Number 7240011
  • Madrid, Spain, 28046
    • Investigational Site Number 7240014
  • Sabadell, Spain, 08208
    • Investigational Site Number 7240016
  • Santa Cruz De Tenerife, Spain, 38320
    • Investigational Site Number 7240015
• Sweden
  • Uppsala, Sweden, 751 85
    • Investigational Site Number 7520001
  • Örebro, Sweden, 701 85
    • Investigational Site Number 7520003
• Switzerland
  • St. Gallen, Switzerland, 9007
    • Investigational Site Number 7560002
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Investigational Site Number 8260006
  • Gateshead, United Kingdom, NE9 6SX
    • Investigational Site Number 8260004
  • Leeds, United Kingdom, LS7 4SA
    • Investigational Site Number 8260003
  • Manchester, United Kingdom, M13 9WL
    • Investigational Site Number 8260005
  • Portsmouth, United Kingdom, PO6 3LY
    • Investigational Site Number 8260011
• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Investigational Site Number 8400002
    • Gainesville, Florida, United States, 32608
      • Investigational Site Number 8400017
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Investigational Site Number 8400014
  • Oregon
    • Portland, Oregon, United States, 97239
      • Investigational Site Number 8400018
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Site Number 8400019
  • Texas
    • Dallas, Texas, United States, 75231
      • Investigational Site Number 8400011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Sarilumab matching placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration
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.	Drug: Sarilumab matching placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration
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.	Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration; Drug: Sarilumab SAR153191; Pharmaceutical form: solution for injection Route of administration: subcutaneous
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.	Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration; Drug: Sarilumab SAR153191; Pharmaceutical form: solution for injection Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: EFC15068; 2017-002988-18 (EudraCT Number); U1111-1200-2184 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No