ow doses of Rituximab in Graves orbitopathy

Conditions: Active moderate to severe Graves Orbitopathy
MedDRA version: 14.1Level: PTClassification code 10060742Term: Endocrine ophthalmopathySystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-001980-53-IT

Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Treatment with rituximab of the active phase of GO, prevention of progression to greater severity and reduction of the degree of residual moscle involvement;Secondary Objective: Analysis of rituximab effects at the level of target tissues (thyroid and orbit).;Primary end point(s): Reduction of clinical activity score =2 points or below CAS=3.;Timepoint(s) of evaluation of this end point: At week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Reduction of severity of GO disease of at least 2 classes NOSPECS; reduction of proptosis =2 mm; reduction of lid fissure of at least =2 mm; reduction of diplopia according to Gorman Score = 1 class or of the motility of at least 8 degrees; numebr of therapeutic responses; number of active disease recurrences; stadiation of signs of residual disease; improvement of GO-Qol scale of at least 6 points.<br>Observational end-point: at week 24 in order to evaluate disease residual and relapses.;Timepoint(s) of evaluation of this end point: 24 weeks