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It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age > 50 years
GCA fulfilling ≥3/5 ACR criteria
Newly diagnosed GCA or relapsing GCA if treatments (Glucocorticoids±immunosuppressants) have been stopped for at least 6 months
Glucocorticoids started for less than 21 days
Proof of large vessel vasculitis:
For men and women of a child-bearing age, an effective method of contraception must be used by the patient or his or her partner throughout the treatment with tocilizumab (or placebo) and for 3 months after the end of the treatment. Breast-feeding is not authorised until 3 months after the end of treatment with tocilizumab. Women not considered at risk of pregnancy are those defined by menopause of at least one year or surgically steriles (ligature of the fallopian tubes, bilateral ovariectomy or hysterectomy)
Persons who have provided written informed consent
Persons covered by the National Health Insurance Agency
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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