This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance versus withdrawal in Giant cell arteritis (GCA) patients who are in remission after at least 12 months of high dose TCZ treatment. Eligible participants will also have discontinued glucocorticoids (e.g., prednisone (or equivalent)) entirely at least three months before randomization. High dose TCZ treatment includes 6-8 mg/kg intravenously (IV) monthly or 162 mg subcutaneously (SC) weekly, which are two forms of administration that are commonly used in clinical practice and are equally efficacious in controlling GCA This research study has three parts: 1. The screening phase (up to 42 days) consists of collecting information about your health and your GCA, a physical exam, and blood tests to see If you qualify to enroll in the study 2. The study treatment phase (withdrawal/step down dosing phase study months 0 - 18) consists of you either completely stopping or decreasing your current dose of tocilizumab while collecting information about your health and your GCA as well as blood samples every two months at clinic visits 3. The safety follow-up phase (months 19-30) consists of collecting information about your health and your GCA as well as blood samples every three months The primary objective is to determine the rate of disease relapse at 18 months in participants with GCA who receive low-dose TCZ compared to those who discontinue TCZ
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
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
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.
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGJohns Hopkins Hospital: Division of Rheumatology Vasculitis Center
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
Boston, Massachusetts, United States
RECRUITINGNorthwell Health: Division of Rheumatology and Allergy-Clinical Immunology
Great Neck, New York, United States
RECRUITINGHospital for Special Surgery, New York: Division of Rheumatology
New York, New York, United States
NOT_YET_RECRUITINGUniversity of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology
Pittsburgh, Pennsylvania, United States
RECRUITINGProportion of patients in sustained remission
Sustained remission and clinical relapse will be determined by the investigator based on clinical signs and symptoms of active Giant cell arteritis (GCA) and PMR regardless of the values of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). The absence of clinical signs and symptoms of active GCA and PMR over the TCZ Withdrawal/Step-Down Dosing and Follow-Up Phases will define sustained remission through Months 18 and 30, respectively. Clinical relapse will be based on recurrent signs or symptoms attributed to GCA regardless of the values of ESR and CRP. To fulfill the definition of a disease relapse, the investigator must make the decision to intensify the participants GCA treatment
Time frame: Through Month 18
Time to disease relapse
Time frame: Through Month 30
Number of disease relapses
Time frame: At Months 18 and 30
Annualized relapse rate
Time frame: At Months 18 and 30
Cumulative prednisone (or equivalent) dose
Time frame: At Months 18 and 30
Cumulative Glucocorticoid Toxicity Index (GTI) excluding the bone density domain
calculated as the cumulative worsening score (CWS) and aggregate improvement score (AIS)
Time frame: At Months 18 and 30
Clinical features of disease relapse
Sustained remission and clinical relapse will be determined by the investigator based on clinical signs and symptoms of active Giant cell arteritis (GCA) and PMR regardless of the values of ESR and CRP. The absence of clinical signs and symptoms of active GCA and PMR over the TCZ Withdrawal/Step-Down Dosing and Follow-Up Phases will define sustained remission through Months 18 and 30, respectively. Clinical relapse will be based on recurrent signs or symptoms attributed to GCA regardless of the values of ESR and CRP. To fulfill the definition of a disease relapse, the investigator must make the decision to intensify the participants GCA treatment
Time frame: Through Month 30
The number of Adverse Events (AEs)
Time frame: At Months 18 and 30
The nature of Adverse Events (AEs)
Time frame: At Months 18 and 30
The severity of Adverse Events (AEs)
Time frame: At Months 18 and 30
The number of Serious Adverse Events (SAEs)
Time frame: At Months 18 and 30
The nature of Serious Adverse Events (SAEs)
Time frame: At Months 18 and 30
Proportion of patients in sustained remission
Time frame: Through Month 30
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