Tocilizumab Dose-tapering & Interruption in Patients With Giant Cell

Status Recruiting

Clinical Trial Summary

Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been found to have a crucial role in the pathogenesis of Giant cel arteritis (GCA). Based on this rationale, several recent studies demonstrated the efficacy of tocilizumab (TCZ), an anti-IL-6 targeted monoclonal antibody, for the treatment of patients with refractory GCA. Confirming previous reports,in a recent retrospective study the investigators successfully treated 10 patient with refractory GCA with TCZ. All patients achieved a complete disease remission evaluated by clinical, laboratory, and positron emission tomography (PET). In a considerable number of GCA patients treated with corticosteroids (CS) the therapy may be interrupted with no disease flares. No data are available on the management of patients achieving the remission with TCZ.

Clinical Trial Description

Study design. Open-label, prospective, pilot study on patients with giant cell arteritis (GCA) resistant to corticosteroids (CS) .

Setting. Rheumatology department, Hospital of Prato, Prato, Italy. Treatment. All refractory GCA patients with or without involvement of aorta and its thoracic branches treated with intravenous TCZ at the dose of 8 mg/Kg/monthly or subcutaneous TCZ at the dose of 162 mg/weekly who achieved a stable remission over a 6-month period should receive reduced TCZ doses with the following schedules: intravenous TCZ tapering to 2 mg/Kg/monthly with drug withdrawal at month 4, and subcutaneous TCZ monthly reduction through the lengthening of injection intervals every 2, 3 , and 4 weeks, and with drug interruption at month 4.

Primary end-point. To investigate the maintenance of clinical remission after TCZ interruption over a 6-month follow-up period.

Secondary end-points. To assess the maintenance of clinical remission during the treatment, to evaluate the role of acute-phase reactants and PET in predicting the relapse and remission, and to assess the occurrence of adverse event (AEs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03244709
Study type	Interventional
Source	Hospital of Prato
Contact
Status	Recruiting
Phase	Phase 4
Start date	January 1, 2015
Completion date	December 31, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03812302` - Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)	Phase 2
Recruiting	`NCT02257866` - Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Recruiting	`NCT04888221` - Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement	Phase 3
Recruiting	`NCT05380453` - Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission	Phase 3
Recruiting	`NCT02333708` - Study of Circulating Microparticles in Giant Cell Arteritis
Completed	`NCT01450137` - Tocilizumab for Patients With Giant Cell Arteritis	Phase 2
Completed	`NCT03827018` - KPL-301 for Subjects With Giant Cell Arteritis	Phase 2
Active, not recruiting	`NCT04519580` - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Recruiting	`NCT04239196` - Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA	Phase 2
Recruiting	`NCT06460142` - Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
Completed	`NCT03202368` - An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)	Phase 3
Not yet recruiting	`NCT02523625` - Giant Cell Arteritis: Improving Use of Ultrasound Evaluation	N/A
Completed	`NCT03285945` - FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment	N/A
Completed	`NCT02190916` - Vasculitis Illness Perception (VIP) Study	N/A
Recruiting	`NCT01241305` - One-Time DNA Study for Vasculitis
Terminated	`NCT02531633` - Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis	Phase 3
Completed	`NCT03409913` - Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA	N/A
Completed	`NCT03765424` - Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
Completed	`NCT01910038` - Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.	Phase 2
Not yet recruiting	`NCT04012905` - Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms