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Tocilizumab Effect iN pOlymyalgia Rheumatica (TENOR)

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Brest
Sponsor:
Collaborator:
Chugai
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01713842
First received: September 17, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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) .


Condition Intervention Phase
Polymyalgia Rheumatica
 Drug: TCZ
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Efficacy at W12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    PMR-AS at week 12


Secondary Outcome Measures:
  • Safety and efficacy during the study [ Time Frame: Week 2,4,8,12,16,20 and 24 ] [ Designated as safety issue: Yes ]
    • 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 ]


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713842

Contacts
Contact: Valérie DEVAUCHELLE, Pr valerie.devauchelle-pensec@chu-brest.fr

Locations
France
Brest University Hospital Recruiting
Brest, France, 29609
Contact: Valérie DEVAUCHELLE, Pr         valerie.devauchelle-pensec@chu-brest.fr    
Principal Investigator: Valérie DEVAUCHELLE, Pr            
Sub-Investigator: Alain SARAUX, Pr            
Sub-Investigator: Divi CORNEC, Dr            
Sub-Investigator: Thierry MARHADOUR, Dr            
Nantes University Hospital Not yet recruiting
Nantes, France, 44000
Contact: Jean-Marie BERTHELOT, Dr            
Principal Investigator: Jean-Marie BERTHELOT, Dr            
Sponsors and Collaborators
University Hospital, Brest
Chugai
Investigators
Principal Investigator: Valérie DEVAUCHELLE, Pr CHRU de Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01713842     History of Changes
Other Study ID Numbers: RB 11-075 TENOR
Study First Received: September 17, 2012
Last Updated: October 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Tocilizumab
Polymyalgia Rheumatica
Glucocorticotherapy
PMR-AS

Additional relevant MeSH terms:
Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013