Polymyalgia Rheumatica
Conditions
Keywords
Tocilizumab, Polymyalgia Rheumatica, Glucocorticotherapy, PMR-AS
Brief 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) .
Interventions
DRUGTCZ
Tocilizumab at week 0, 4 and 8.
Sponsors
Chugai Pharmaceutical
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy at W12 | 12 Weeks | PMR-AS at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and efficacy during the study | Week 2,4,8,12,16,20 and 24 | * To maintain low disease activity (PMR-AS) in the low corticosteroid dose group from W12 to W24 * On the inflammatory changes (synovitis, myositis, tenosynovitis aund bursitis) between baseline, W2 and 12 visualize by ultrasonography, MRI and Tep-Scan. * On sparing corticosteroid, with the comparison of the cumulative corticosteroid dosage beetwen the two groups of patients in the phase 2, W12 to 24. * On the circulating serum cytokines and immunoregulators (IL-6, IL-1, BLyS/BAFF, IL-6 receptor, gp130) and B cells receptors and on the phenotype of circulating T- and B-cells between baseline and W4 and 12 On inflammatory parameters (CRP and ESR) between baseline and W 2,4,8,12,16,20 and 24 * On the quality of life of patients between baseline and W 4,12,16, 20 and 24 * To evaluate the side-effects in relation to the use of Tocilizumab treatment. \[ Time Frame: After first, second and third treatment and during follow up \] |
Countries
France
Outcome results
None listed