Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
NCT ID: NCT02908217
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
113 participants
INTERVENTIONAL
2017-02-15
2020-11-12
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Tocilizumab
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.
Tocilizumab
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
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Placebo
6 Intravenous infusions of placebo every 4 weeks.
Interventions
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Tocilizumab
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
6 Intravenous infusions of placebo every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fulfilled the Chuang criteria
* And currently:
* PMR-AS\> 10
* Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
* Able to give informed consent
* Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.
Exclusion Criteria
* Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
* History of major organ or haematopoietic stem cell/marrow transplant
* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
* Planned surgical procedure within 12 months after randomization.
* History of malignant neoplasm within the last 5 years.
* Current active infection
* Patient with elevated ALT or AST\> 5 ULN
50 Years
ALL
No
Sponsors
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Roche Chugai
INDUSTRY
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Valérie Devauchelle-Pensec, Pr
Role: PRINCIPAL_INVESTIGATOR
CHRU de Brest
Locations
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Hopital Nord service de rhumatologie-Franche Comté
Belfort, , France
CIC Besançon
Besançon, , France
CHU Besançon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
CHRU Brest
Brest, , France
Centre hospitalier Sud-Francilien
Corbeil-Essonnes, , France
CHU Dijon
Dijon, , France
CH Le Mans
Le Mans, , France
Hôpital européen
Marseille, , France
Ch Des Pays de Morlaix
Morlaix, , France
CH Mulhouse
Mulhouse, , France
CHU de Nancy
Nancy, , France
CHU Nantes
Nantes, , France
hôpital Sapêtrière -APHP
Paris, , France
CHU Rennes
Rennes, , France
CHU St Etienne
Saint-Etienne, , France
CHRU de Strasbourg
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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SEMAPHORE (RB15.210)
Identifier Type: -
Identifier Source: org_study_id