Randomized controlled study of rituximab and steroid treatment in thyroid-associeted ophthalmopathy (TAO) - ND

OSPEDALE MAGGIORE DI MILANO (IRCCS)0 个研究点开始时间: 2008年1月4日最近更新: 2012年9月3日

适应症

试验速览

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•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

•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.

发起方

OSPEDALE MAGGIORE DI MILANO (IRCCS)