Anti-CD20 antitest alkalmazása súlyos, hagyományos kezelésekre nem reagáló endokrin orbitopátiába
- Conditions
- Endocrin ophthalmopathy (conventional therapy resistent).
- Registration Number
- EUCTR2006-006099-39-HU
- Lead Sponsor
- Department of Endocrinology University of Debrecen Medical and Health Science Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
-decompression operation
-grave hyper or hypothyreosis
-fever
-treatment with monoclonal antibodies
-allergy needing treatment
-pregnancy or lactacion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method