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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2032-08-31

Brief Summary

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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.

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Detailed Description

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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

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Giant Cell Arteritis (GCA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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26 weeks glucocorticoid

26 weeks glucocorticoid taper

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

Participant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.

8 weeks glucocorticoid

8 weeks glucocorticoid taper

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

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

Interventions

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Prednisone

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

Intervention Type DRUG

Prednisone

Participant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No