Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone: a Randomized, Multicenter, Adaptive, Blinded, Phase III Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Absence of a major relapse from randomization to 52 weeks
Study Overview
Brief Summary
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.
Detailed Description
The aim of this randomized clinical trial investigates whether 1) a shortened GC 8-week regimen is as effective as the current 26-week regimen and 2) associated with less GC exposure when introducing a GC-sparing agent in the treatment of GCA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
8 weeks glucocorticoid
8 weeks glucocorticoid taper
Intervention: Prednisone (Drug)
26 weeks glucocorticoid
26 weeks glucocorticoid taper
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Absence of a major relapse from randomization to 52 weeks
Time Frame: 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
Time Frame: 52 weeks
Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.
Secondary Outcomes
No secondary outcomes reported