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Trial record 4 of 130 for:    GCA

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

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ClinicalTrials.gov Identifier: NCT03244709
Recruitment Status : Unknown
Verified August 2017 by Fabrizio Cantini, Hospital of Prato.
Recruitment status was:  Recruiting
First Posted : August 9, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Fabrizio Cantini, Hospital of Prato

Brief 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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Tocilizumab Phase 4

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission: a Prospective, Pilot Study.
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017


Arm Intervention/treatment
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.
Drug: Tocilizumab
Intravenous Tocilizumab followed by subcutaneousTocilizumab




Primary Outcome Measures :
  1. 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 ]
    ESR ≤15 mm/h; CRP ≤0.5 mg/dl; VAS pain ≤10; PET: normalized SUVmax ≤1


Secondary Outcome Measures :
  1. The percentage of patients achieving and maintaining the clinical remission during the treatment with TCZ as expressed by the absence of GCA symptoms and signs, normal ESR and CRP values, absence of arterial wall inflammation at PET examination [ Time Frame: 12 months ]
    Absence of GCA symptoms and signs, ESR ≤15 mm/h, CRP ≤0.5 mg/dL, PET: normalized SUVmax ≤1

  2. To compare the role of acute-phase reactants and 18F-FDG-PET in the evaluation of remission. [ Time Frame: Months 6,12,18 ]
    Linear regression analysis for the correlation between ESR and CRP values and nSUVmax at baseline and after therapy

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" MeDRA 12.1. [ Time Frame: Month 18 ]
    Overall AEs and serious AEs will be recorded



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All consecutive patients meeting the 1990 ACR classification criteria for GCA.

Exclusion Criteria:

  • Corticosteroid treatment during the previous 6 months.
  • Uncontrolled diabetes.
  • Uncontrolled hypertension.
  • History of cancer within the past 5 years.
  • History of frequent infections in the past.
  • Positivity of screening procedures for latent tuberculosis infection.
  • Uncontrolled dyslipidemia at baseline.
  • Known intestinal diverticulosis.
  • Concomitant hematologic disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244709


Locations
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Italy
Fabrizio Cantini Recruiting
Prato, Tuscany, Italy, 59100
Contact: Fabrizio Cantini, MD    +393408075607    fbrzcantini@gmail.com   
Contact: Carlotta Nannini, MD    +390574807578    nannini.car@gmail.com   
Sponsors and Collaborators
Hospital of Prato

Publications of Results:
Other Publications:
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Responsible Party: Fabrizio Cantini, Director of the Dpt. of Rheumatology, Hospital of Prato
ClinicalTrials.gov Identifier: NCT03244709     History of Changes
Other Study ID Numbers: Hospital of Prato, Italy
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fabrizio Cantini, Hospital of Prato:
Giant cell arteritis,
Tocilizumab
Aortitis
Remission
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases