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Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
NCT07108387 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Tocilizumab
- DRUG Discontinue Tocilizumab
Study Locations (7)
New York
- Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology — Great Neck
- Hospital for Special Surgery, New York: Division of Rheumatology — New York
Georgia
- Emory University School of Medicine: Division of Rheumatology — Atlanta
Illinois
- Northwestern University — Chicago
Maryland
- Johns Hopkins Hospital: Division of Rheumatology Vasculitis Center — Baltimore
Massachusetts
- Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases — Boston
Pennsylvania
- University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2025-12-11 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07108387
The ClinicalTrials.gov registry entry for NCT07108387 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Giant Cell Arteritis (GCA) appearing as the primary indexed condition, and to 2 interventions — of which Tocilizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07108387 reports 7 study locations spanning 6 distinct geographic areas — top geographies include New York, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07108387 about?
NCT07108387 is a clinical study titled "Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis". 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 tre...
What is the current status of trial NCT07108387?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2025-12-11. Estimated completion is 2029-02-01.
What conditions does trial NCT07108387 study?
This clinical trial studies the following conditions: Giant Cell Arteritis (GCA). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07108387?
The interventions under investigation include: Tocilizumab (DRUG), Discontinue Tocilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07108387?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07108387 being conducted?
This trial has 7 study locations across Georgia, Illinois, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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