Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisone, Prednisone.
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis (GCA). Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- Drug Prednisone
Participant randomization to receive shortened (8 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent. - Drug Prednisone
Participant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.
Primary outcome measures
- Absence of a major relapse from randomization to 52 weeks [Time frame: 52 weeks]
- Cumulative glucocorticoid exposure from randomization to 52 weeks [Time frame: 52 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Department of Rheumatology and Immunology, Inselspital, University of Bern — Bern
Identifiers
NCT: NCT06833411 · GISCO