Tocilizumab Effect iN pOlymyalgia Rheumatica (TENOR)

February 10, 2015 updated by: University Hospital, Brest

Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

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) .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Brest University Hospital
      • Nantes, France, 44000
        • Nantes University Hospital
      • Orléans, France, 45000
        • CHR d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCZ
Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion
Drug: TCZ
Tocilizumab at week 0, 4 and 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy at W12
Time Frame: 12 Weeks
PMR-AS at week 12
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and efficacy during the study
Time Frame: 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 ]
Week 2,4,8,12,16,20 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Chugai Pharmaceutical

Investigators

  • Principal Investigator: Valérie DEVAUCHELLE, Pr, CHRU de Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB 11-075 TENOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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