Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

Last updated: December 3, 2020
Sponsor: University Hospital, Brest
Overall Status: Completed

Phase

3

Condition

Polymyalgia Rheumatica (Pmr)

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02908217
SEMAPHORE (RB15.210)
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age older than 50 years
  • Fulfilled the Chuang criteria
  • And currently:
  • PMR-AS> 10
  • Absence of signs or symptoms of other musculoskeletal or connective tissueconditions
  • Able to give informed consent
  • Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted ifstable dose since 3 months.

Exclusion

Exclusion Criteria:

  • Clinical symptoms of giant cell arteritis
  • 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 diseasesnot 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

Study Design

Total Participants: 113
Study Start date:
February 15, 2017
Estimated Completion Date:
November 12, 2020

Connect with a study center

  • Hopital Nord service de rhumatologie-Franche Comté

    Belfort, 90000
    France

    Site Not Available

  • CHU Besançon

    Besançon, 25030
    France

    Site Not Available

  • CIC Besançon

    Besançon, 25000
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Site Not Available

  • CHRU Brest

    Brest, 29200
    France

    Site Not Available

  • Centre hospitalier Sud-Francilien

    Corbeil Essonnes, 91106
    France

    Site Not Available

  • CHU Dijon

    Dijon,
    France

    Site Not Available

  • CH Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • Hôpital européen

    Marseille, 13003
    France

    Site Not Available

  • Ch Des Pays de Morlaix

    Morlaix, 29600
    France

    Site Not Available

  • CH Mulhouse

    Mulhouse,
    France

    Site Not Available

  • CHU de Nancy

    Nancy, 54511
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Site Not Available

  • hôpital Sapêtrière -APHP

    Paris, 75013
    France

    Site Not Available

  • CHU Rennes

    Rennes, 35203
    France

    Site Not Available

  • CHU St Etienne

    St Etienne,
    France

    Site Not Available

  • CHRU de Strabourg

    Strabourg, 67098
    France

    Site Not Available

  • CHRU de Strasbourg

    Strasbourg, 67098
    France

    Site Not Available

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