Tocilizumab Effect iN pOlymyalgia Rheumatica

Phase 2

Completed

• Conditions: Polymyalgia Rheumatica
• Interventions: Drug: TCZ

• Registration Number: NCT01713842
• Lead Sponsor: University Hospital, Brest

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-25
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TCZ	TCZ	Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion

Primary Outcome Measures

Name	Time	Method
Efficacy at W12	12 Weeks	PMR-AS at week 12

Secondary Outcome Measures

Name	Time	Method
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. \[ Time Frame: After first, second and third treatment and during follow up \]

Trial Locations

Locations (3)

Brest University Hospital; 🇫🇷 Brest, France

Nantes University Hospital; 🇫🇷 Nantes, France

CHR d'Orléans; 🇫🇷 Orléans, France