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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06833411

Acronym

GISCO

Enrollment

178

Registered

2025-02-18

Start date

2026-07-01

Completion date

2032-08-01

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis (GCA)

Keywords

Tocilizumab, Glucocorticoid, Prednisone, Giant cell arteritis

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.

Interventions

DRUGPrednisone

Participant randomization to receive shortened (8 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Switzerland

Contacts

CONTACTLisa Christ, Dr. med.

RI-Studien@insel.ch+41 31 63 2 72 29

PRINCIPAL_INVESTIGATORLisa Christ, Dr. med.

Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026