Thyroid associeted ophthalmopathy. MedDRA version: 6.1 Level: SOC Classification code 10015919
Conditions
Interventions
Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
OSPEDALE MAGGIORE DI MILANO (IRCCS)
Eligibility
Sex/Gender
All
Inclusion criteria
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 ophthalmophaty (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, as long as it has been stopped at least 3 month before, may be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindications to therapy with rituximab or methylprednisolone (pregnancy, breast feeding, diabetes, known coronary artery disease, significant cardiac arrhytmias, 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' ophtalmopathy, previous orbital radiotherapy, refusal of treatment. Patients with known allergy to paracetamol, difenidramine, hydrocortisone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment with rituximab of the active phase of Graves' ophthalmopathy, prevention of progression to greater severity and reduction of the degree of residual moscle involvement, by comparison to i.v. steroid therapy.;Secondary Objective: Analisys 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 | — |
Countries
Italy
Outcome results
None listed