Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone

Phase 3

Not yet recruiting

• Conditions: Giant Cell Arteritis (GCA)
• Interventions: Drug: Prednisone

• Registration Number: NCT06833411
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2026-01
• Primary Completion: 2030-08
• Study Completion: 2032-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 178

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
26 weeks glucocorticoid	Prednisone	26 weeks glucocorticoid taper
8 weeks glucocorticoid	Prednisone	8 weeks glucocorticoid taper

Primary Outcome Measures

Name	Time	Method
Absence of a major relapse from randomization to 52 weeks	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	52 weeks	Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.

Trial Locations

Locations (1)

Department of Rheumatology and Immunology, Inselspital, University of Bern; 🇨🇭 Bern, Switzerland