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

Recruiting Phase 2 Interventional Study
Giant Cell Arteritis (GCA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
78 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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About This Trial
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 equi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ability and willingness to provide written informed consent and to comply with the study protocol 2. Diagnosis of Giant cell arteritis (GCA) classified according to the following criteria: a. AND at least one of the following: i. Cranial signs or symptoms of GCA (new-…
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