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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03745586
Study type Interventional
Source University Hospital Inselspital, Berne
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 1, 2018
Completion date March 1, 2021

See also
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