Active moderate-severe Graves' Orbitopathy MedDRA version: 20.0 Level: LLT Classification code 10015684 Term: Exophthalmos endocrine System Organ Class: 100000004853 MedDRA version: 20.1 Level: LLT Classification code 10014702 Term: Endocrine exophthalmos System Organ Class: 100000004853
Conditions
Interventions
Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO
Product Name: Roactemra
Product Code: Tocilizumab
Pharmaceutical Form: C
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Male or female, 18-75 years old 3. Women of childbearing potential should use effective contraception (abstinence or use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients with severe Graves’ orbitopathy (severe keratopathy, compression optic neuropathy and inflammatory optic neuropathy);Treatment with any biological therapy at any time; Previous oral or intravenous corticosteroid treatment in the last three months except for oral steroid not exceeding a cumulative dose of 1 gr. ; Plasmapheresis within 90 days prior to Day 0.; Treatment with intravenous immunoglobulin; Azathioprine more than 100 mg/day within 30 days before screening; Administration of live vaccines given within 30 days prior to administration of (Day 0) or concurrently with tocilizumab (during study); Splenectomy; Subjects at risk of haemorrhage that threatens a vital organ; History of a major organ transplant or hematopoietic stem cell/marrow transplant; History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix; Required management of infections, as follows: currently on any suppressive therapy for a chronic infection, hospitalization for treatment of infection within 60 days before Day 0, use of parenteral antibiotics within 60 days before Day 0, use of oral antibiotics within 30 days before Day 0; Pregnancy; Patients with reproductive potential not willing to use an effective method of contraception; Breast feeding; Previous history of intestinal ulceration or diverticulitis; Known unstable coronary artery disease; Significant cardiac arrhythmias; Severe congestive heart failure; Other serious chronic illness (including nervous system disease, pulmonary disease including obstructive pulmonary disease, renal disease);Active infection; History of recurrent clinically significant infection or recurrent bacterial infections; History of sarcoidosis; Primary or secondary immunodeficiency; History of IgE-mediated or non-IgE-mediated hypersensitivity; Positive PPD or quantiferon without documentation of treatment for TB infection; Denied consent to HIV testing; Previous orbital radiotherapy; Patients positive for HBsAg; Patients positive for HBcAb regardless of HBsAb status will undergo HBV DNA which, if positive, will be excluded; Patients positive at screening Hepatitis C antibody; Positive test for Human Immunodeficiency Virus (HIV) antibody at screening or historically; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater or equal to 1.5x upper limit of normal (ULN); Alkaline phosphatase and bilirubin>1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is 1.4 mg/dl (124 µmol/L) in female patients and > 1.6 mg/dl (141 µmol/L) in male patients; He
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of therapy on active GO and on disease progression ;Secondary Objective: Effect of therapy on the proportion of patients with inactivation and reactivation of disease, improvement of QoL, the degree of residual disease after the inflammatory phase and safety of treatment.;Primary end point(s): Proportion of patients improved at 24 weeks as assessed by the EUGOGO composite ophthalmic score;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of rehabilitative surgical interventions at the end of follow-up;Timepoint(s) of evaluation of this end point: at week 48 | — |
Countries
Italy
Contacts
Public ContactUOC Endocrinologia
Fondazione IRCCS Ca' Granda Ospedale Maggiore Polcilinico
Outcome results
None listed