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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Primary Purpose

Giant Cell Arteritis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sarilumab SAR153191

Sarilumab matching placebo

Prednisone

Prednisone matching placebo

About this trial

This is an interventional treatment trial for Giant Cell Arteritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Placebo+52 Week Taper

Placebo+26 Week Taper

Sarilumab 150mg q2w+26 Week Taper

Sarilumab 200mg q2w+26 Week Taper

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24

Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.

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).

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.

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.

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.

Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52

Full Information

NCT ID

NCT03600805

First Posted

July 17, 2018

Last Updated

March 15, 2022

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03600805

Brief Title

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Protracted recruitment timeline exacerbated by COVID-19 pandemic

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

November 24, 2020 (Actual)

Study Completion Date

November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Giant Cell Arteritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo+52 Week Taper

Arm Type

Experimental

Arm Description

Arm Title

Placebo+26 Week Taper

Arm Type

Experimental

Arm Description

Arm Title

Sarilumab 150mg q2w+26 Week Taper

Arm Type

Placebo Comparator

Arm Description

Arm Title

Sarilumab 200mg q2w+26 Week Taper

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sarilumab SAR153191

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Sarilumab matching placebo

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Pharmaceutical form: tablets or capsules Route of administration: oral administration

Intervention Type

Drug

Intervention Name(s)

Prednisone matching placebo

Intervention Description

Pharmaceutical form: capsules Route of administration: oral administration

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved Sustained Disease Remission at Week 52

Description

Time Frame

At Week 52

Title

Percentage of Participants Who Achieved Sustained Disease Remission at Week 24

Description

Time Frame

At Week 24

Secondary Outcome Measure Information:

Title

Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set

Description

Time Frame

Up to Week 12

Title

Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population

Description

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.

Time Frame

Up to Week 12

Title

Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set

Description

Time Frame

From Week 12 through Week 52

Title

Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population

Description

Time Frame

From Week 12 through Week 24

Title

Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set

Description

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.

Time Frame

From Week 12 through Week 52

Title

Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population

Description

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.

Time Frame

From Week 12 through Week 24

Title

Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set

Description

Time Frame

From Week 12 through Week 52

Title

Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population

Description

Time Frame

From Week 12 through Week 24

Title

Total Cumulative Corticosteroid (Including Prednisone) Dose

Description

Time Frame

Up to Week 52

Title

Time to First Giant Cell Arteritis Disease Flare

Description

Time Frame

Up to Week 52

Title

Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population

Description

Time Frame

At Week 24

Title

Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52

Description

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.

Time Frame

At Week 52

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Description

Time Frame

From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60)

Title

Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab

Description

Time Frame

Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52

Title

Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24

Description

Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.

Time Frame

post-dose at Week 24

Title

Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response

Description

Time Frame

From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60)

Title

Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Description

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.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Title

Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Description

CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Title

Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52

Description

Time Frame

Baseline, Weeks 2, 12, 24, and 52

Title

Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52

Description

Time Frame

Baseline, Weeks 2, 12, 24, and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8400002

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Investigational Site Number 8400017

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Investigational Site Number 8400014

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Investigational Site Number 8400018

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Investigational Site Number 8400019

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 8400011

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 0320001

City

Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Investigational Site Number 0320002

City

Caba

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Investigational Site Number 0360003

City

Camberwell

ZIP/Postal Code

3124

Country

Australia

Facility Name

Investigational Site Number 0360006

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Investigational Site Number 0360001

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Investigational Site Number 0560001

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 1240007

City

Hamilton

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Investigational Site Number 1240010

City

Montreal

ZIP/Postal Code

H4A 3T2

Country

Canada

Facility Name

Investigational Site Number 1240001

City

Rimouski

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Investigational Site Number 1240005

City

Sherbrooke

ZIP/Postal Code

J1G 2E8

Country

Canada

Facility Name

Investigational Site Number 1240003

City

Trois-Rivières

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Investigational Site Number 1910001

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Investigational Site Number 2080002

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Investigational Site Number 2080003

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

Investigational Site Number 2330001

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Investigational Site Number 2500005

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Investigational Site Number 2500002

City

Montivilliers

ZIP/Postal Code

76290

Country

France

Facility Name

Investigational Site Number 2500003

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Investigational Site Number 2500007

City

Mulhouse

ZIP/Postal Code

68100

Country

France

Facility Name

Investigational Site Number 2500001

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Investigational Site Number 2500006

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Investigational Site Number 2760001

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Investigational Site Number 2760002

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Investigational Site Number 2760003

City

Kirchheim Unter Teck

ZIP/Postal Code

73230

Country

Germany

Facility Name

Investigational Site Number 2760004

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Investigational Site Number 2760007

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Investigational Site Number 3480001

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 3760006

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Investigational Site Number 3760004

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Investigational Site Number 3800001

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 3800005

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Investigational Site Number 5280007

City

Den Haag

ZIP/Postal Code

2545 CH

Country

Netherlands

Facility Name

Investigational Site Number 5280005

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Investigational Site Number 5280009

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Investigational Site Number 5280001

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Investigational Site Number 6200001

City

Almada

ZIP/Postal Code

2801-951

Country

Portugal

Facility Name

Investigational Site Number 6200005

City

Aveiro

ZIP/Postal Code

3810-501

Country

Portugal

Facility Name

Investigational Site Number 6200004

City

Ponte De Lima

ZIP/Postal Code

4990-041

Country

Portugal

Facility Name

Investigational Site Number 6430005

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

Investigational Site Number 6430002

City

Moscow

ZIP/Postal Code

115404

Country

Russian Federation

Facility Name

Investigational Site Number 6430003

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Investigational Site Number 7050001

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Investigational Site Number 7240010

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Investigational Site Number 7240011

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 7240014

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Investigational Site Number 7240016

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 7240015

City

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Investigational Site Number 7520001

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Investigational Site Number 7520003

City

Örebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Investigational Site Number 7560002

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Investigational Site Number 8260006

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Investigational Site Number 8260004

City

Gateshead

ZIP/Postal Code

NE9 6SX

Country

United Kingdom

Facility Name

Investigational Site Number 8260003

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Investigational Site Number 8260005

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Investigational Site Number 8260011

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Giant Cell Arteritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial