Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

ClinicalTrials.gov ID: NCT03600805

Public ClinicalTrials.gov record NCT03600805. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 12:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT03600805
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Sanofi; Industry
Enrollment: 83 participants

Conditions and interventions

Conditions

Giant Cell Arteritis

Interventions

Drug

Eligibility (public fields only)

Age range: 50 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 19, 2018
Primary completion: Nov 23, 2020
Completion: Nov 23, 2020
Last update posted: Mar 27, 2022

2018 – 2020

United States locations

U.S. sites: 6
U.S. states: 5
U.S. cities: 6

Facility	City	State	ZIP	Site status
Investigational Site Number 8400002	Boca Raton	Florida	33486	—
Investigational Site Number 8400017	Gainesville	Florida	32608	—
Investigational Site Number 8400014	Iowa City	Iowa	52242	—
Investigational Site Number 8400018	Portland	Oregon	97239	—
Investigational Site Number 8400019	Philadelphia	Pennsylvania	19104	—
Investigational Site Number 8400011	Dallas	Texas	75231	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03600805, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 27, 2022 · Synced Sep 11, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03600805 live on ClinicalTrials.gov.

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