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

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ClinicalTrials.gov Identifier: NCT02908217
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Roche Chugai
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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.


Condition or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: Tocilizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: Intravenous infusions of tocilizumab

Placebo Comparator: Placebo
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Drug: Placebo
6 Intravenous infusions of placebo every 4 weeks.
Other Name: Intravenous infusions of placebo




Primary Outcome Measures :
  1. Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24). [ Time Frame: From week 0 to week 24 ]
    PMR-AS measure


Secondary Outcome Measures :
  1. Proportion of patients with (PMR-AS>17) in both arm [ Time Frame: From Week 24 to Week 32 ]
    PMR-AS measure

  2. PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. [ Time Frame: From inclusion to week 32 ]
    PMR-AS measure

  3. Cumulative dosages of GCs at Week 32 [ Time Frame: Week 32 ]
    dosages of GCs



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 tissue conditions
  • Able to give informed consent
  • Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908217


Contacts
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Contact: Valérie Devauchelle-Pensec, Pr 0033 2 98 34 72 64 valerie.devauchelle-pensec@chu-brest.fr

Locations
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France
Hopital Nord service de rhumatologie-Franche Comté Recruiting
Belfort, France, 90000
Contact: anne LOHSE         
Contact       Anne.LOHSE@hnfc.fr   
CIC Besançon Recruiting
Besançon, France, 25000
Contact: Eric Toussirot, Pr         
Principal Investigator: Eric Toussirot, Pr         
CHU Besançon Recruiting
Besançon, France, 25030
Contact: Daniel Wendling, Pr         
Principal Investigator: Daniel Wendling, Pr         
CHU Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Christophe Richez, Pr         
Principal Investigator: Christophe Richez, Pr         
CHRU Brest Recruiting
Brest, France, 29200
Contact: Valérie Devauchelle-Pensec         
Principal Investigator: Valérie Devauchelle-Pensec, Pr         
Sub-Investigator: Alain Saraux, Pr         
Centre hospitalier Sud-Francilien Recruiting
Corbeil Essonnes, France, 91106
Contact: Pascal HILLIQUIN         
Contact       Pascal.Hilliquin@ch-sud-francilien.fr   
CHU Dijon Not yet recruiting
Dijon, France
Contact: Bernard BONNOTTE         
Contact       bernard.bonnotte@chu-dijon.fr   
CH Le Mans Recruiting
Le Mans, France, 72037
Contact: Emmanuelle Dernis, Dr         
Principal Investigator: Emmanuelle Dernis, Dr         
Hôpital européen Recruiting
Marseille, France, 13003
Contact: Laurent CHICHE         
Contact       l.chiche@hopital-europeen.fr   
Ch Des Pays de Morlaix Recruiting
Morlaix, France, 29600
Contact: catherine LE HENAFF         
Contact    0033298626041    CLehenaff@ch-morlaix.fr   
CH Mulhouse Recruiting
Mulhouse, France
Contact: Pierre KIEFFER         
Contact       kiefferp@ghrmsa.fr   
CHU de Nancy Not yet recruiting
Nancy, France, 54511
Contact: Isabelle Chary-Valckenaere, Pr    03 83 15 32 03    i.valckenaere@chru-nancy.fr   
CHU Nantes Recruiting
Nantes, France, 44093
Contact: Jean-Marie Berthelot, Dr         
Principal Investigator: Jean-Marie Berthelot, Dr         
hôpital Sapêtrière -APHP Recruiting
Paris, France, 75013
Contact: Bruno-Jean FAUTREL, Pr         
Contact       bruno.fautrel@aphp.fr   
CHU Rennes Recruiting
Rennes, France, 35203
Contact: Aleth Perdriger, Pr         
Principal Investigator: Aleth Perdriger, Pr         
CHU St Etienne Not yet recruiting
St Etienne, France
Contact: Hubert MAROTTE         
Contact       hubert.marotte@chu-st-etienne.fr   
CHRU de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Jacques Eric GOTTENBERG         
Contact       jacques-eric.gottenberg@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Brest
Roche Chugai
Investigators
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Principal Investigator: Valérie Devauchelle-Pensec, Pr CHRU de Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02908217     History of Changes
Other Study ID Numbers: SEMAPHORE (RB15.210)
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Polymyalgia Rheumatica
Tocilizumab
Glucocorticoid
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs