Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06833411

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

Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone: a Randomized, Multicenter, Adaptive, Blinded, Phase III Study

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
178 (estimated)
Sponsor
Insel Gruppe AG, University Hospital Bern · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPrednisoneParticipant randomization to receive shortened (8 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.
DRUGPrednisoneParticipant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.

Timeline

Start date
2026-01-01
Primary completion
2030-08-01
Completion
2032-08-01
First posted
2025-02-18
Last updated
2025-02-24

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT06833411. Inclusion in this directory is not an endorsement.