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

Insel Gruppe AG, University Hospital Bern

Status and phase: Begins enrollment in 6 months; Phase 3

Conditions: Giant Cell Arteritis (GCA)

Treatments: Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT06833411

GISCO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups

26 weeks glucocorticoid

Active Comparator group

Description:

26 weeks glucocorticoid taper

Treatment:

Drug: Prednisone

Drug: Prednisone

8 weeks glucocorticoid

Experimental group

Description:

8 weeks glucocorticoid taper

Treatment:

Drug: Prednisone

Drug: Prednisone