Tocilizumab Discontinuation or Dose Reduction for Giant Cell Arteritis
This study is for people with Giant Cell Arteritis (GCA), a condition that causes inflammation of blood vessels, who are currently in remission after at least 12 months of high-dose Tocilizumab (TCZ) treatment and have stopped taking steroids. Researchers want to see if continuing TCZ at a lower dose (either 4 mg/kg intravenously monthly or 162 mg subcutaneously every two weeks) is better than stopping TCZ completely. The main goal is to find out what proportion of patients stay in remission for 18 months. You would be eligible if you are 50 years or older, have a GCA diagnosis, and meet other specific criteria.
- Study design
- This is a multi-center, randomized, open-label study involving 78 participants. It compares two approaches for managing Giant Cell Arteritis.
- What's involved
- If you discontinue Tocilizumab, you will have visits at Week 2, Month 1 and 2, and then every 2 months until Month 18. If you remain in remission, you will enter a follow-up phase for an additional 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for 18 months to assess sustained remission, with an additional 12-month follow-up phase for those who remain in remission.
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Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
At a glance
Conditions
Where it's being run
7 sites across 6 statesStudy leadership
- Sebastian H Unizony, M.D. · STUDY_CHAIR · Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
Who to contact
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What this trial measures
- Proportion of patients in sustained remissionThrough Month 18
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