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

NCT07108387 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-15

No results posted yet for this study

Summary

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

Conditions

  • Giant Cell Arteritis (GCA)

Interventions

DRUG

Tocilizumab

Participants will continue Tocilizumab (TCZ) at a lower dose of either 4 mg/kg IV monthly or 162 mg SC every 2 weeks Participants randomized to the stepped-down treatment arm will receive TCZ on their current route of administration. The route of administration may change if needed during study participation at the discretion of the investigator

DRUG

Discontinue Tocilizumab

Participants will discontinue Tocilizumab and will have visits at Week 2, Month 1 and 2, and then every 2 months during the TCZ Withdrawal Phase until the Month 18 Visit. Participants who remain in remission will enter the Follow-Up Phase for an additional 12 months at Month 18 and will continue withdrawal at that time.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sebastian H Unizony, M.D. · Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2027-06-11
Completion
2030-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07108387 on ClinicalTrials.gov