Rituximab treatment in patients with tjyroid associated that do not respond to intravenous steroids or relapse after intravenous steroid treatment
- Conditions
- Thyroid associated opthalmopathyTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2011-000899-33-SE
- Lead Sponsor
- Department of Endocrinology, Sahlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
Inclusion criteria
•Man or woman between 18-70 years.
•TAO with CAS of = 4 (less than 3 months).
•Euthyroid for at least 6 weeks
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
•Dysthyroid optic neuropathy (DON)
•Ulcerative Keratitis
•Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment)
•Previous Treatment with Rituximab (MabThera®)
•Positive Hepatitis B or C serology.
•Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization
•History of recurrent significant infection or history of recurrent bacterial infections
•Patient who may not attend to the protocol according to the investigators opinion.
•Pregnancy or lactation
•Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease).
•Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
•Concomitant malignancies or previous malignancies.
• Previous active tuberculosis
•Alkoholism
•Alkoholic related liver disease or other chronical liver disease
•Bone marrow depression with leukopenia, thrombocytopenia or significant anemia
•Reumatoid or other significant pulmonary disease
•Allergy to the active substance or any other substance in the medications or murine proteins
•Active, severe infections (such as tuberculosis, sepsis or opportunistic infections)
•Patients with severe immunosuppression
•Severe cardiac failure or severe uncontrolled heart disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method