Giant Cell Arteritis (GCA)Phase 3GISCONCT06833411
Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone
A Phase 3 study testing Prednisone in people with Giant Cell Arteritis (GCA), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- What is being tested?
- Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2026to Aug 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Department of Rheumatology and Immunology, Inselspital, University of Bern
Bern
Lisa Christ, Dr. med., +41 31 632 7229, RI-Studien@insel.ch
Lisa Christ, Dr. med.
About this study
Official 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
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.
Read the 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.
- Conditions
- Giant Cell Arteritis (GCA)
- Being tested
- Prednisone
- Keywords
- Tocilizumab, Glucocorticoid, Prednisone, Giant cell arteritis
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Participant randomization to receive shortened (8 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.
PrednisoneDrug
Participant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.
| Study group | Role | What they receive |
|---|---|---|
| 26 weeks glucocorticoid | Active comparator | 26 weeks glucocorticoid taper Receives: Drug: Prednisone |
| 8 weeks glucocorticoid | Experimental | 8 weeks glucocorticoid taper Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study startJul 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Christ, Dr. med., Principal investigator, Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833411
- Sponsor's protocol ID
- GISCO
- Acronym
- GISCO
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No