NCT03726749

Tocilizumab Plus a Short Prednisone Taper for GCA

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Giant Cell Arteritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor
DRUG	Prednisone	Prednisone is an anti-inflammatory medication

Timeline

• Start date: 2018-11-28
• Primary completion: 2021-12-15
• Completion: 2021-12-29
• First posted: 2018-10-31
• Last updated: 2022-12-02
• Results posted: 2022-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study