Tocilizumab Effect iN pOlymyalgia Rheumatica

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-10-31

Brief Summary

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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) .

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Detailed Description

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Conditions

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Polymyalgia Rheumatica

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCZ

Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion

Group Type EXPERIMENTAL

TCZ

Intervention Type DRUG

Tocilizumab at week 0, 4 and 8.

Interventions

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TCZ

Tocilizumab at week 0, 4 and 8.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No