Erdheim Chester patology MedDRA version: 15.0 Level: HLT Classification code 10020118 Term: Histiocytoses System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: ROACTEMRA*INF FL 4ML 20MG/ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/mill
Sponsors
OSPEDALE S. RAFFAELE DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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 ( 1.6 mg / dL in women or> 1.9 mg / dl in male patients, AST and / or ALT = 3 x ULN, platelets 2.0 mg / dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): efficacy and safety of Tocilizumab;Timepoint(s) of evaluation of this end point: 4 weeks after the last administration | — |
Countries
Italy
Contacts
Public ContactMedicina ind. immunologico clinico
IRCCS Ospedale San Raffaele
Outcome results
None listed