Tocilizumab Effect iN pOlymyalgia Rheumatica

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborator: Chugai Pharmaceutical

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