Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab (GUSTO)
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|ClinicalTrials.gov Identifier: NCT03745586|
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : January 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Giant Cell Arteritis||Drug: Tocilizumab Drug: Glucocorticoids||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||August 1, 2021|
|Experimental: All study participants||
Day 3: Tocilizumab infusion (8mg/kg body-weight) Day 10- week 52: Tocilizumab s.c. injections (162mg) in weekly intervals
Day0-day2: methylprednisolone 500mg i.v.
- Remission [ Time Frame: Week 24 ]Proportion of patients achieving remission within 31 days and without relapse until week 24
- Remission [ Time Frame: Week 24 and week 52 ]Proportion of patients with complete relapse-free remission of disease at week 24 and at week 52
- Time to first relapse [ Time Frame: through study completion, an average of 1 year ]Time to first relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745586
|Contact: Peter M Villiger, Prof||+41 (0)31 632 98 firstname.lastname@example.org|
|Department of Rheumatology||Not yet recruiting|
|Reggio Emilia, Italy|
|Contact: Carlo Salvarani, Prof|
|University Hospital Bern, Inselspital||Recruiting|
|Contact: Peter Villiger, Prof|
|Principal Investigator:||Peter Villiger, Prof||University of Bern|