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| Name | Class |
|---|---|
| Chugai Pharmaceutical | INDUSTRY |
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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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCZ | Experimental | Tocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCZ | Drug | Tocilizumab at week 0, 4 and 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy at W12 | PMR-AS at week 12 | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy during the study |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie DEVAUCHELLE, Pr | CHRU de Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR d'Orléans | Orléans | France | 45000 | France | ||
| Brest University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33301930 | Derived | Carvajal Alegria G, Garrigues F, Bettacchioli E, Loeuille D, Saraux A, Cornec D, Devauchelle-Pensec V, Renaudineau Y. Tocilizumab controls bone turnover in early polymyalgia rheumatica. Joint Bone Spine. 2021 May;88(3):105117. doi: 10.1016/j.jbspin.2020.105117. Epub 2020 Dec 7. | |
| 30877202 | Derived | Laporte JP, Garrigues F, Huwart A, Jousse-Joulin S, Marhadour T, Guellec D, Cornec D, Devauchelle-Pensec V, Saraux A. Localized Myofascial Inflammation Revealed by Magnetic Resonance Imaging in Recent-onset Polymyalgia Rheumatica and Effect of Tocilizumab Therapy. J Rheumatol. 2019 Dec;46(12):1619-1626. doi: 10.3899/jrheum.180958. Epub 2019 Mar 15. |
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| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| Week 2,4,8,12,16,20 and 24 |
| Brest |
| 29609 |
| France |
| Nantes University Hospital | Nantes | 44000 | France |
| 26929219 | Derived | Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29. |
| D017437 | Skin and Connective Tissue Diseases |