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NCT07108387 · ClinicalTrials.gov registry record · Phase 2
Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
A Phase 2 study of Giant Cell Arteritis (GCA), sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 7
- Study locations
NCT07108387: Recruiting Phase 2 study of Giant Cell Arteritis (GCA), sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07108387 is a Phase 2 study of Giant Cell Arteritis (GCA) that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07108387, a Phase 2 study of Giant Cell Arteritis (GCA), is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 7
- Study locations
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
Primary Outcome
Sustained remission and clinical relapse will be determined by the investigator based on clinical signs and symptoms of active Giant cell arteritis (GCA) and PMR regardless of the values of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). The absence of clinical signs and symptoms of active GCA and PMR over the TCZ Withdrawal/Step-Down Dosing and Follow-Up Phases will define sustained remission through Months 18 and 30, respectively. Clinical relapse will be based on recurrent
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 |
What NCT07108387 shows while recruiting
NCT07108387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
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.
NCT07108387 lists 7 locations in 6 states (New York, Georgia, Illinois).
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).
What interventions are being tested in trial NCT07108387?
The interventions under investigation include: Tocilizumab (DRUG), Discontinue Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT07108387?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07108387's enrollment target sits among peer trials
78 884th of 2000 higher than 1,111 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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