Tocilizumab for Giant Cell Arteritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called Tocilizumab (TCZ) to determine if people with giant cell arteritis (GCA), a condition causing inflammation in blood vessels, can maintain remission without the drug or on a lower dose. The trial aims to discover whether stopping or reducing TCZ affects the likelihood of the disease returning. Participants should have been symptom-free on high-dose TCZ for at least a year and have stopped using steroids like prednisone for at least three months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial requires participants to have stopped taking glucocorticoids at least three months before joining. Other medications, especially biologic immunosuppressants, must be stopped 12 months prior, and non-biologic immunosuppressants three months prior, except for hydroxychloroquine if the dose is stable. The protocol does not specify other medications, so it's best to discuss with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tocilizumab (TCZ) is generally safe for people with giant cell arteritis (GCA). One study found that while more than half of the patients might experience a relapse after more than a year of treatment, most did not need to stop the medication due to serious side effects.
However, patients using TCZ may face a higher risk of infections, sometimes serious enough to require hospitalization. Despite this, recent studies have not identified any new safety concerns, which is reassuring.
Additionally, the FDA has approved TCZ for treating GCA, supporting its safety. The safety of TCZ is also well established for other conditions like rheumatoid arthritis, providing further confidence in its use.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for Giant Cell Arteritis, which typically involves long-term use of glucocorticoids like prednisone, Tocilizumab offers a different approach by targeting the interleukin-6 (IL-6) receptor. Researchers are excited about Tocilizumab because it can potentially reduce or eliminate the need for steroids, minimizing their well-known side effects. Additionally, Tocilizumab is available in both subcutaneous and intravenous forms, providing flexibility in administration to suit patient needs. These features make Tocilizumab a promising option for managing Giant Cell Arteritis more effectively and safely.
What evidence suggests that this trial's treatments could be effective for Giant Cell Arteritis?
Studies have shown that tocilizumab can help many patients manage giant cell arteritis (GCA). In one study, most patients stayed in remission after long-term use of tocilizumab. Another study found that 42% of patients remained in remission after a year of treatment with tocilizumab while reducing prednisone, a type of steroid. In this trial, participants will be assigned to different arms to evaluate the effects of tocilizumab withdrawal or step-down dosing. Research has also shown that gradually stopping tocilizumab over two years effectively kept GCA symptoms at bay, with any flare-ups being minor and manageable. These findings suggest that tocilizumab is a strong option for managing GCA.678910
Who Is on the Research Team?
Sebastian H Unizony, M.D.
Principal Investigator
Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
Are You a Good Fit for This Trial?
This trial is for patients with well-controlled Giant Cell Arteritis who have been on high-dose Tocilizumab treatment for at least 12 months and off glucocorticoids like prednisone for three months. Participants must be in remission to qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants either completely stop or decrease their current dose of tocilizumab while collecting health information and blood samples every two months
Follow-up
Participants are monitored for safety and effectiveness after treatment, with health information and blood samples collected every three months
What Are the Treatments Tested in This Trial?
Interventions
- Tocilizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor