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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03244709
• Date of registration: 01/08/2017
• Prospective Registration: No
• Primary sponsor: Hospital of Prato
• Public title: Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.
• Scientific title: Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission: a Prospective, Pilot Study.
• Date of first enrolment: January 1, 2015
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03244709
• Study type: Interventional
• Study design: Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Fabrizio Cantini, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" MeDRA 12.1. [Time Frame: Month 18]

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]

To compare the role of acute-phase reactants and 18F-FDG-PET in the evaluation of remission. [Time Frame: Months 6,12,18]

Secondary ID(s)

Hospital of Prato, Italy

Source(s) of Monetary Support

Please refer to primary and secondary sponsors