tocilizumab effect in polymyalgia rheumatica

Conditions: Polymyalgia Rheumatica

Summary: phase 1: patients are treated with infusions of tocilizumab (tcz) for 3 months. clinical evaluation is performed using pmr-as. the pmr-as is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: pmr-as (activity scale = as) = c reactive protein (crp) (mg/dl) + patient scale (vasp) (0-10 scale) + physician scale (vasph) (0-10 scale) + morning stiffness(mst) \[min\]×0.1) + elevation of upper limbs (eul) (0-3 scale). at the end of the phase 1,the patients stop tcz and entered in phase 2 at week 12. phase 2: all the patients are included in the phase 2 and treated with glucocorticoid (gc)for 3 months. two arms are possible according to the pmr-as. either the classical gc treatment (0.3mg/kg), either a low dose group of gc(0.15mg/kg) .


Eligibility criteria:
inclusion criteria: * age between 50 years and 75 years included * pmr-as \> 10 * pmr according to the chuang criteria * evolving since less than 12 months * without horton disease * able to understand and accept the study * agree to sign the inform consent form * without gc, or at least during 1 month and stop since 7 days before the inclusion. * stable dose of nonsteroidal anti-inflammatory since 4 weeks before the inclusion. * birth controlled during all the study and 6 months after exclusion criteria: * disagree to participated * unable to understand the study * participation to an other study in the 3 months before the inclusion * treated by gc at 0.3mg/kg/d in the past 7 days * less than 50 years old or more than 75 years old * uncontrolled dyslipidemia, high blood pressure or cardiovascular disease * histories of important allergy * historically positive test or test positive at screening for hiv-1 antibody, hepatitis b surface antigen, or hepatitis c antibody. * abnormal screening blood test : leukocyte count less than 3.5 × 109 cells/l, neutrophil count less than 2 × 109 cells/l, hemoglobin level less than 85 g/l, platelet count less than 100 × 109 cells/l, or hepatic aminotransferase or alkaline phosphatase levels greater than 3 times the upper limit of normal * other inflammatory rheumatic disease or connective disease * clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to pmr (eg. cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) * current drug or alcohol abuse * patients treated with an immunosuppressive agents in the past 4 weeks * live/attenuated vaccine in the past 4 weeks * clinical symptoms of giant cell arteritis * history of infection or infestation in the past 3 months * active tuberculosis * planned surgical procedure * history of malignant neoplasm within the last 5 years, except for adequately treated cancer of the skin (basal or squamous cell) * history or current tumoral hematological disease * severe allergic or anaphylactic reactions about one of the tcz component * pregnant women during the study and six month after the end of the study * breast feeding mother * dysthyroidia * unstable treatment by statin in the past 3 months * parkinson disease * fibromyalgia * peripheric arthritis * articular chondrocalcinosis or hydorxyapatites rhumatisms

Keywords: tocilizumab polymyalgia rheumatica glucocorticotherapy pmr-as