About this trial
The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis
* with tocilizumab, * while using less cortisone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with giant cell arteritis
Start of tocilizumab treatment at baseline as part of routine clinical practice
Receive ≥ 20 mg/day prednisone (or equivalent) at baseline
Written informed consent
Disqualifiers
Treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.
Trial design
Single group
Treatments tested in this trial
Prednisone
DrugParticipant randomization to receive shortened (8 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.
Prednisone
DrugParticipant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.
Treatment groups
Trial outcomes
Primary outcomes
Absence of a major relapse from randomization to 52 weeks
Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.
Cumulative glucocorticoid exposure from randomization to 52 weeks
Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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