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

Conditions

• Giant Cell Arteritis (GCA)

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  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
• Discontinue Tocilizumab — DRUG
  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.

Study Details

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

Key Dates

Start date

Dec 11, 2025

Status verified

Jun 2026

Primary completion

Jun 11, 2027

Completion

Jan 11, 2030

Study Design

Enrollment

78 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab Step-Down Dosing Arm
  Randomization will be performed within strata defined by gender, whether the participant has a history of Giant cell arteritis (GCA) relapse, and whether the participant has a history of polymyalgia rheumatica (PMR) symptoms. Patients in remission of high dose Tocilizumab (TCZ) \>=12months and discontinued glucocorticoids (e.g. prednisone) \>=3 months will receive 162mg subcutaneously (SC) every 2 weeks or 4mg/Kg intravenously (IV) monthly for 18 months Participants who remain in remission will enter the Follow-Up Phase for an additional 12 months at Month 18 and will discontinue TCZ at that time
• Other: Tocilizumab Withdrawal Arm
  Randomization will be performed within strata defined by gender, whether the participant has a history of Giant cell arteritis (GCA) relapse, and whether the participant has a history of PMR symptoms. Patients in remission of high dose Tocilizumab (TCZ) \>=12months and discontinued glucocorticoids (e.g. prednisone) \>=3 months 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.

Primary Outcome Measure

Proportion of patients in sustained remission [ Time Frame: Through Month 18 ]

Locations (7)

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