Tocilizumab Effect iN pOlymyalgia Rheumatica

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