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| Name | Class |
|---|---|
| Roche Chugai | INDUSTRY |
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Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 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).
All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | 6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks. |
|
| Placebo | Placebo Comparator | 6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24). | PMR-AS measure | From week 0 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with (PMR-AS>17) in both arm | PMR-AS measure | From Week 24 to Week 32 |
| PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. | PMR-AS measure |
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Inclusion Criteria:
Age older than 50 years
Fulfilled the Chuang criteria
And currently:
Able to give informed consent
Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie Devauchelle-Pensec, Pr | CHRU de Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Nord service de rhumatologie-Franche Comté | Belfort | 90000 | France | |||
| CIC Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36125471 | Derived | Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, Richez C, Truchetet ME, Wendling D, Toussirot E, Perdriger A, Gottenberg JE, Felten R, Fautrel BJ, Chiche L, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Chary-Valckenaere I, Cornec D, Guellec D, Marhadour T, Nowak E, Saraux A. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1053-1062. doi: 10.1001/jama.2022.15459. |
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|
| Placebo | Drug | 6 Intravenous infusions of placebo every 4 weeks. |
|
|
| From inclusion to week 32 |
| Cumulative dosages of GCs at Week 32 | dosages of GCs | Week 32 |
| Besançon |
| 25000 |
| France |
| CHU Besançon | Besançon | 25030 | France |
| CHU Bordeaux | Bordeaux | 33076 | France |
| CHRU Brest | Brest | 29200 | France |
| Centre hospitalier Sud-Francilien | Corbeil-Essonnes | 91106 | France |
| CHU Dijon | Dijon | France |
| CH Le Mans | Le Mans | 72037 | France |
| Hôpital européen | Marseille | 13003 | France |
| Ch Des Pays de Morlaix | Morlaix | 29600 | France |
| CH Mulhouse | Mulhouse | France |
| CHU de Nancy | Nancy | 54511 | France |
| CHU Nantes | Nantes | 44093 | France |
| hôpital Sapêtrière -APHP | Paris | 75013 | France |
| CHU Rennes | Rennes | 35203 | France |
| CHU St Etienne | Saint-Etienne | France |
| CHRU de Strasbourg | Strasbourg | 67098 | France |
| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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