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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

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE August 9, 2017
Last Update Posted Date August 10, 2017
Actual Study Start Date  ICMJE January 1, 2015
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03244709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.
Official Title  ICMJE Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission: a Prospective, Pilot Study.
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Giant Cell Arteritis
Intervention  ICMJE Drug: Tocilizumab
Intravenous Tocilizumab followed by subcutaneousTocilizumab
Study Arms  ICMJE 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.
Intervention: Drug: Tocilizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 4, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03244709
Other Study ID Numbers  ICMJE Hospital of Prato, Italy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fabrizio Cantini, Hospital of Prato
Study Sponsor  ICMJE Hospital of Prato
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital of Prato
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP