NCT03745586

Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Giant Cell Arteritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	Day 3: Tocilizumab infusion (8mg/kg body-weight) Day 10- week 52: Tocilizumab s.c. injections (162mg) in weekly intervals
DRUG	Glucocorticoids	Day0-day2: methylprednisolone 500mg i.v.

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-11-30
• Completion: 2021-03-01
• First posted: 2018-11-19
• Last updated: 2021-06-22

Locations

1 site across 1 country: Switzerland