Tocilizumab administration in patients affected by Erdheim-Chester patology.
- Conditions
- Erdheim Chester patologyMedDRA version: 15.0Level: HLTClassification code 10020118Term: HistiocytosesSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-003151-11-IT
- Lead Sponsor
- OSPEDALE S. RAFFAELE DI MILANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-Patients aged > = 18 years able to understand and sign an informed consent--diagnosis of ECD histologically documented ; -advanced disease limited to the skeleton, with at least one measurable lesion; -disease progression in the course of now most commonly used therapies (eg corticosteroids, interferon-alpha, methotrexate) or a location (such as cardiac or CNS) known to be unresponsive to any of the treatments currently available; -if women of childbearing age are necessary: a negative pregnancy test and the ability to exclude securely the beginning of a pregnancy for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
-history of hypersensitivity to tocilizumab or to any of the excipients;-serious infections requiring hospitalization or antibiotic therapy within 30 days before enrollment in the study;-active tuberculosis, listeriosis, histoplasmosis, sepsis, abscesses, opportunistic infections, active HBV or HCV-previous history of tuberculosis (as documented by a positive PPD skin test and / or a positive QuantiFERON test and / or chest radiography), in the absence of documented and appropriate administration of a specific treatment for tuberculosis latent-history of infection with HIV-past history (<5 years before enrollment) of a lymphoproliferative disorder or a solid tumor (excluding treated basal cell or squamous cell carcinoma of the skin);-moderate or severe heart failure (class NYHAIII / IV), uncontrolled diabetes mellitus or other diseases that, in the opinion of the physician responsible for the protocol can be detrimental to the patient if he / she would enroll in the study, history of alcohol-and / or drug abuse - previous treatment with alkylating agents (chlorambucil, cyclophosphamide);-serum creatinine> 1.6 mg / dL in women or> 1.9 mg / dl in male patients, AST and / or ALT = 3 x ULN, platelets <100.000/fL; hemoglobin <8.5 g / dl, WBC <1000 / fL; lymphocytes <500/fL, total bilirubin> 2.0 mg / dL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the efficacy and safety of Tocilizumab in the treatment of the disease Erdheim-Chester extrascheletrica.;Secondary Objective: evaluate the efficacy and safety of Tocilizumab in the treatment of the disease Erdheim-Chester extrascheletrica.;Primary end point(s): efficacy and safety of Tocilizumab;Timepoint(s) of evaluation of this end point: 6 months after the beginning of the treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): efficacy and safety of Tocilizumab;Timepoint(s) of evaluation of this end point: 4 weeks after the last administration