NCT03745586: GUSTO

Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab

Completed Phase 1, PHASE2 Last updated 22 June 2021

What this trial tests

Phase 1, PHASE2 trial testing Tocilizumab in Giant Cell Arteritis in 18 participants. Completed in 1 March 2021.

Timeline

1 December 2018

Primary endpoint
30 November 2020

1 March 2021

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 December 2018
Primary completion	30 November 2020
Estimated completion	1 March 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Tocilizumab (tocilizumab) — full drug profile →
• Glucocorticoids — full drug profile →

Conditions studied

• Giant Cell Arteritis — all drugs for Giant Cell Arteritis →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

50 and older, any sex, with Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Two recent RCTs showed the ability of tocilizumab to induce and maintain remission of giant cell arteritis. Both studies used the dosing schemes for Rheumatoid Arthritis (i.e. 8mg/kg bodyweight i.v. in 4-weekly intervals and 162mg weekly s.c., respectively). In both trials glucocorticoids (GC) were initially administrated at medium to high doses with subsequent rapid reduction and discontinuation over 24 weeks. In case of relapse, GC doses were re-increased.

The results of both studies suggest that GC could be reduced more rapidly. This would further reduce GC-induced adverse effects.

Thus, the investigators propose to perform an open label single arm study to assess the efficacy of ultra-short co-medication with GC, using Simon's minimax two-stage design.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tocilizumab monotherapy after ultra-short glucocorticoid administration in giant cell arteritis: a single-arm, open-label, proof-of-concept study.
   Christ L, Seitz L, Scholz G, Sarbu AC, et al · · 2021 · cited 43× · PMID 38287611 · DOI 10.1016/s2665-9913(21)00152-1
2. Quantitative ultrasound to monitor the vascular response to tocilizumab in giant cell arteritis.
   Seitz L, Christ L, Lötscher F, Scholz G, et al · · 2021 · cited 41× · PMID 34117737 · DOI 10.1093/rheumatology/keab484
3. Advances in the Treatment of Giant Cell Arteritis.
   Castañeda S, Prieto-Peña D, Vicente-Rabaneda EF, Triguero-Martínez A, et al · · 2022 · cited 27× · PMID 35329914 · DOI 10.3390/jcm11061588
4. Vision loss in patients with giant cell arteritis treated with tocilizumab.
   Amsler J, Kysela I, Tappeiner C, Seitz L, et al · · 2021 · cited 16× · PMID 33752737 · DOI 10.1186/s13075-021-02480-4
5. Serum proteomics in giant cell arteritis in response to a three-day pulse of glucocorticoid followed by tocilizumab monotherapy (the GUSTO trial).
   Christ L, Gloor AD, Kollert F, Gaber T, et al · · 2023 · cited 5× · PMID 37287970 · DOI 10.3389/fimmu.2023.1165758
6. Current developments in the diagnosis and treatment of giant cell arteritis.
   Szekeres D, Al Othman B. · · 2022 · cited 5× · PMID 36582285 · DOI 10.3389/fmed.2022.1066503