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

NCT06833411 | Not Yet Recruiting Phase 3

• 1 other identifier: GISCO
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis (GCA)

Keywords

Tocilizumab; Glucocorticoid; Prednisone; Giant cell arteritis

Outcome Measures

Primary Outcomes (2)

• Absence of a major relapse from randomization to 52 weeks

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

  52 weeks

• Cumulative glucocorticoid exposure from randomization to 52 weeks

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

  52 weeks

Study Arms (2)

26 weeks glucocorticoid

ACTIVE COMPARATOR

26 weeks glucocorticoid taper

Drug: Prednisone

8 weeks glucocorticoid

EXPERIMENTAL

8 weeks glucocorticoid taper

Drug: Prednisone

Interventions

Prednisone DRUG

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

8 weeks glucocorticoid

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Rheumatology and Immunology, Inselspital, University of Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lisa Christ, Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Christ, Dr. med.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)