Endocrin ophthalmopathy (conventional therapy resistent).
Conditions
Interventions
Trade Name: Mabthera
Product Name: Rituximab
Pharmaceutical Form: Injection*
Sponsors
Department of Endocrinology University of Debrecen Medical and Health Science Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinically active, endocrin ophthalmopathy -activity score (CAS =5) -activity of the immunological in one eye -the patients treatment was not followed by becoming better in after 4 weeks of combined treatment (corticosteroid and irradiation) 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: -decompression operation -grave hyper or hypothyreosis -fever -treatment with monoclonal antibodies -allergy needing treatment -pregnancy or lactacion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To treat with anti-CD20 (Mabthera) patients with conventional therapy resistent endocrin ophthalmopathy.;Secondary Objective: To investigate safety and tolerability of Mabthera treatment in patients with endocrin ophthalmopathy.;Primary end point(s): Tests (laboratory and MR or SPECT) on the 90th day after first treatment. | — |
Countries
Hungary
Outcome results
None listed