Actively Recruiting
Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-09
78
Participants Needed
7
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Diagnosis of Giant Cell Arteritis (GCA) with cranial symptoms or polymyalgia rheumatica (PMR) symptoms
- Evidence of GCA confirmed by artery biopsy or imaging studies
- Ongoing treatment with high-dose Tocilizumab (6-8 mg/kg IV monthly or 162 mg SC weekly) for at least 12 months
- Disease remission for at least 12 months with normal C-reactive protein (CRP) levels
- No glucocorticoid treatment for at least 3 months prior to randomization
You will not qualify if you...
- Autoimmune disease or other condition requiring chronic or recurrent glucocorticoids or immunomodulatory therapy (except topical/inhaled)
- Hospitalization within 8 weeks before randomization
- Suspected or established adrenal insufficiency
- Treatment with investigational agents within 12 months before randomization
- Use of other biologic immunosuppressants within 12 months or non-biologic immunosuppressants within 3 months prior to randomization (except stable hydroxychloroquine)
- Live or attenuated vaccine within 4 weeks before randomization
- Severe allergic reactions to Tocilizumab or prednisone
- Serious uncontrolled cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, psychiatric, bone, eye, or gastrointestinal diseases
- Evidence of chronic hepatitis B or C infection without clearance
- Positive tuberculosis test without appropriate clearance or prophylaxis
- Active infections (except minor fungal or superficial skin infections)
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Recent infections requiring IV or oral antibiotics
- Active malignancy treatment (except prophylactic hormonal therapy)
- History of substance abuse within 12 months
- History of chronic or recurrent infection within 12 months
- History of opportunistic infection within 12 months without clearance
- Abnormal liver enzymes, low platelet, hemoglobin, white blood cell, or neutrophil counts at screening
- Any other medical issues that may pose risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States, 30307
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
3
Johns Hopkins Hospital: Division of Rheumatology Vasculitis Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology
Great Neck, New York, United States, 11021
Actively Recruiting
6
Hospital for Special Surgery, New York: Division of Rheumatology
New York, New York, United States, 10021
Not Yet Recruiting
7
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology
Pittsburgh, Pennsylvania, United States, 15217
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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