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Clinical trialNCT07108387RecruitingPhase 2Interventional

Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment78Giant Cell Arteritis (GCA)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance versus withdrawal in Giant cell arteritis (GCA) patients who are in remission after at least 12 months of high dose TCZ treatment. Eligible participants will also have discontinued glucocorticoids (e.g., prednisone (or equivalent)) entirely at least three months before randomization. High dose TCZ treatment includes 6-8 mg/kg intravenously (IV) monthly or 162 mg subcutaneously (SC) weekly, which are two forms of administration that are commonly used in clinical practice and are equally efficacious in controlling GCA This research study has three parts: 1. The screening phase (up to 42 days) consists of collecting information about your health and your GCA, a physical exam, and blood tests to see If you qualify to enroll in the study 2. The study treatment phase (withdrawal/step down dosing phase study months 0 - 18) consists of you either completely stopping or decreasing your current dose of tocilizumab while collecting information about your health and your GCA as well as blood samples every two months at clinic visits 3. The safety follow-up phase (months 19-30) consists of collecting information about your health and your GCA as well as blood samples every three months The primary objective is to determine the rate of disease relapse at 18 months in participants with GCA who receive low-dose TCZ compared to those who discontinue TCZ

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Sebastian H Unizony, M.D.

    Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases

    Study Chair

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Emory University School of Medicine: Division of Rheumatology

    Atlanta, Georgia, United States

    Athanasios Tiliakos, DO
    Recruiting
  • Northwestern University

    Chicago, Illinois, United States

    Anisha Dua, MD
    Recruiting
  • Johns Hopkins Hospital: Division of Rheumatology Vasculitis Center

    Baltimore, Maryland, United States

    Brendan Antiochos
    Recruiting
  • Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases

    Boston, Massachusetts, United States

    Sebastian Unizony, MD
    Recruiting
  • Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology

    Great Neck, New York, United States

    Lara El Khoury, MD
    Recruiting
  • Hospital for Special Surgery, New York: Division of Rheumatology

    New York, New York, United States

    Lindsay Lally, MD
    Recruiting
  • University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology

    Pittsburgh, Pennsylvania, United States

    Robyn E. Domsic, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Discontinue TocilizumabTocilizumab →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Jan 2026
Primary completion
11 Jun 2027
Completion
11 Jan 2030
Last update posted
10 Aug 2026
Registered enrollment
78
Registry id
NCT07108387

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.