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
|Condition or disease||Intervention/treatment||Phase|
|Giant Cell Arteritis||Drug: Tocilizumab||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
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:
Intravenous Tocilizumab followed by subcutaneousTocilizumab
- 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
- 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
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
|Prato, Tuscany, Italy, 59100|
|Contact: Fabrizio Cantini, MD +393408075607 email@example.com|
|Contact: Carlotta Nannini, MD +390574807578 firstname.lastname@example.org|