Tocilizumab Effect iN pOlymyalgia Rheumatica (TENOR)
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) .
|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)|
- Efficacy at W12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]PMR-AS at week 12
- 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 ]
|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)|
Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion
Tocilizumab at week 0, 4 and 8.
|Contact: Valérie DEVAUCHELLE, Prfirstname.lastname@example.org|
|Brest University Hospital||Recruiting|
|Brest, France, 29609|
|Contact: Valérie DEVAUCHELLE, Pr email@example.com|
|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|
|CHR d'Orléans||Active, not recruiting|
|Orléans, France, 45000|
|Principal Investigator:||Valérie DEVAUCHELLE, Pr||CHRU de Brest|