Tocilizumab Effect iN pOlymyalgia Rheumatica (TENOR)
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|ClinicalTrials.gov Identifier: NCT01713842|
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : February 11, 2015
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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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion
Tocilizumab at week 0, 4 and 8.
- Efficacy at W12 [ Time Frame: 12 Weeks ]PMR-AS at week 12
- 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 ]
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|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- Unstable treatment by statin in the past 3 months
- Parkinson disease
- Peripheric arthritis
- Articular chondrocalcinosis or hydorxyapatites rhumatisms
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
|Brest University Hospital|
|Brest, France, 29609|
|Nantes University Hospital|
|Nantes, France, 44000|
|Orléans, France, 45000|
|Principal Investigator:||Valérie DEVAUCHELLE, Pr||CHRU de Brest|
|Responsible Party:||University Hospital, Brest|
|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|
Giant Cell Arteritis
Nervous System Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Central Nervous System Diseases
Skin Diseases, Vascular
Immune System Diseases