Tocilizumab Plus a Short Prednisone Taper for GCA

Giant Cell Arteritis Clinical Trial

Official title: Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA)

Status Completed

Clinical Trial Summary

This is an open-label pilot study of tocilizumab (TCZ) 162 mg weekly administered subcutaneously for 52 weeks in combination with 8 weeks of oral prednisone.

Clinical Trial Description

This is a single center, open label study that will assess the efficacy and safety of 52 weeks of tocilizumab (TCZ) in combination with 8-weeks of prednisone in 30 patients with active giant cell arteritis (GCA). Active disease is defined as signs and/or symptoms of GCA plus increased inflammatory markers (e.g., erythrosedimentation rate [ESR] and/or C-reactive protein [CRP]).

The study will enroll subjects with new onset and with relapsing/refractory GCA, and consist of a screening phase (up to 6 weeks), a treatment phase (52 weeks) and a safety follow up phase (4 weeks).

The primary endpoint of the study, sustained remission, will be assessed at week 52.

The definition of sustained remission contains 3 elements:

1. Absence of clinical signs and symptoms of active GCA along with the normalization of the ESR (< 40 mm/hour) and CRP (< 10 mg/L).

2. Completion of the pre-specified prednisone taper protocol

3. Absence of disease flare (relapse) since the induction of remission by week 8.

Disease flare is defined as the re-appearance of unequivocal signs or symptoms of active GCA (with or without elevation of ESR and/or CRP) or the elevation of the ESR and/or CRP that is thought to be due to active GCA and that requires escape therapy. ;

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

• NCT number: NCT03726749
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 4
• Start date: November 28, 2018
• Completion date: December 29, 2021