We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tocilizumab Effect iN pOlymyalgia Rheumatica (TENOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01713842
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : February 11, 2015
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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) .


Condition or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: TCZ Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy at W12 [ Time Frame: 12 Weeks ]
    PMR-AS at week 12


Secondary Outcome Measures :
  1. 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 ]


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713842


Locations
Layout table for location information
France
Brest University Hospital
Brest, France, 29609
Nantes University Hospital
Nantes, France, 44000
CHR d'Orléans
Orléans, France, 45000
Sponsors and Collaborators
University Hospital, Brest
Chugai Pharmaceutical
Investigators
Layout table for investigator information
Principal Investigator: Valérie DEVAUCHELLE, Pr CHRU de Brest
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01713842    
Other Study ID Numbers: RB 11-075 TENOR
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: January 2015
Keywords provided by University Hospital, Brest:
Tocilizumab
Polymyalgia Rheumatica
Glucocorticotherapy
PMR-AS
Additional relevant MeSH terms:
Layout table for MeSH terms
Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases