Preliminary study on the effectiveness of low doses of Rituximab in patients with Graves’ orbitopathy (GO) poorly responding to immunosuppressive steroid treatment.

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO0 sites10 target enrollmentJune 15, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Active moderate to severe Graves Orbitopathy
Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Enrollment: 10
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

June 15, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

•Adult caucasian, asian, hispanic, black patients, males and females, aged 18 \- 75 yrs, smokers and non smokers, euthyroid for at least 6\-8 weeks (defined by normal free thyroid hormone levels), affected by active ophthalmoapthy (clinical activity score \=4/10 o \=3/7\) of moderate\- severe degree, as defined by NOSPECS score. Patients are treated after giving informed consent for therapy. Patients with previous steroid treatment may be included in 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 9
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 1

•Contraindications to therapy with rituximab (pregnancy, breast feeding, diabetes, known coronary artery disease, significant cardiac arrhythmias, severe congestive heart failure, other serious chronic illness, active infection, a 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, known anaphylaxis to mouse\-derived proteins, positive PPD without documentation of treatment for TB infection, a history of cancer excluding resected basal or major squamous cell carcinoma, cervical dysplasia or in situ cervical cancer), denied consent to HIV testing, inactive Graves’ ophthalmopathy, previous orbital radiotherapy, refusal of treatment. Patients with known allergy to paracetamol, difenidramine, hydrocortisone.