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
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 ]
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|