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NCT Number: NCT06833411

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

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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Key information

Conditions

Giant Cell Arteritis (GCA) Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Giant Cell Arteritis Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Rheumatology and Immunology, Inselspital, University of Bern

Bern, Switzerland

Location contact

Lisa Christ, Dr. med.

CONTACT

[email protected]

+41 31 632 7229

Lisa Christ, Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone

Drug

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

Primary outcomes

  1. Absence of a major relapse from randomization to 52 weeks

    Time frame: 52 weeks

    Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.

  2. Cumulative glucocorticoid exposure from randomization to 52 weeks

    Time frame: 52 weeks

    Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Christ, Dr. med.

CONTACT

[email protected]

+41 31 63 2 72 29

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: GISCO

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Feb 18, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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