Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

February 1, 2029

Conditions
Giant Cell Arteritis (GCA)
Interventions
DRUG

Tocilizumab

"Participants will continue Tocilizumab (TCZ) at a lower dose of either 4 mg/kg IV monthly or 162 mg SC every 2 weeks~Participants randomized to the stepped-down treatment arm will receive TCZ on their current route of administration. The route of administration may change if needed during study participation at the discretion of the investigator"

DRUG

Discontinue Tocilizumab

"Participants will discontinue Tocilizumab and will have visits at Week 2, Month 1 and 2, and then every 2 months during the TCZ Withdrawal Phase until the Month 18 Visit.~Participants who remain in remission will enter the Follow-Up Phase for an additional 12 months at Month 18 and will continue withdrawal at that time."

Trial Locations (7)

10021

Hospital for Special Surgery, New York: Division of Rheumatology, New York

11021

Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology, Great Neck

15217

University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology, Pittsburgh

21287

Johns Hopkins Hospital: Division of Rheumatology Vasculitis Center, Baltimore

30307

Emory University School of Medicine: Division of Rheumatology, Atlanta

60611

Northwestern University, Chicago

02114

Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases, Boston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH