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

Sponsor
Hospital of Prato
Study ID
NCT03244709
Phase
PHASE4
Status
Unknown

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Intravenous Tocilizumab followed by subcutaneousTocilizumab

Study Details

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.

Key Dates

Start date
Jan 1, 2015
Status verified
Aug 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
15 participants (estimated)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with GCA (ACR 1990 criteria)
    At diagnosis, all GCA patients with or without involvement of aorta and its thoracic branches will receive PDN 50 mg/day and TCZ 8 mg/Kg/iv monthly. In all patients PDN dose will be reduced of 10 mg every 2 weeks until interruption at week 12. Week 12. Subcutaneous TCZ 162 mg/weekly will be administered for additional 12 weeks. Week 24. TCZ tapering every 8 weeks as follows: * 1 injection every 2 weeks * 1 injection every 3 weeks * 1 injection every 4 weeks Week 48. TCZ withdrawal. Week 72. Remission evaluation.

Primary Outcome Measure

The percentage of patients maintaining the off-therapy clinical remission over the follow-up as expressed by absence of GCA symptoms and signs, normal ESR and CRP values, absence of arterial wall inflammation at PET examination [ Time Frame: 6-month off-therapy period ]

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