Overview

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