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

Primary Purpose

Polymyalgia Rheumatica

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tocilizumab
Placebo
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polymyalgia Rheumatica focused on measuring Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Nord service de rhumatologie-Franche Comté
  • CIC Besançon
  • CHU Besançon
  • CHU Bordeaux
  • CHRU Brest
  • Centre hospitalier Sud-Francilien
  • CHU Dijon
  • CH Le Mans
  • Hôpital européen
  • Ch Des Pays de Morlaix
  • CH Mulhouse
  • CHU de Nancy
  • CHU Nantes
  • hôpital Sapêtrière -APHP
  • CHU Rennes
  • CHU St Etienne
  • CHRU de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tocilizumab

Placebo

Arm Description

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.

6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients with (PMR-AS>17) in both arm
PMR-AS measure
PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.
PMR-AS measure
Cumulative dosages of GCs at Week 32
dosages of GCs

Full Information

First Posted
September 16, 2016
Last Updated
December 3, 2020
Sponsor
University Hospital, Brest
Collaborators
Roche Chugai
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1. Study Identification

Unique Protocol Identification Number
NCT02908217
Brief Title
Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
Official Title
Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
November 12, 2020 (Actual)
Study Completion Date
November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Roche Chugai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Intravenous infusions of tocilizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Intravenous infusions of placebo
Intervention Description
6 Intravenous infusions of placebo every 4 weeks.
Primary Outcome Measure Information:
Title
Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24).
Description
PMR-AS measure
Time Frame
From week 0 to week 24
Secondary Outcome Measure Information:
Title
Proportion of patients with (PMR-AS>17) in both arm
Description
PMR-AS measure
Time Frame
From Week 24 to Week 32
Title
PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.
Description
PMR-AS measure
Time Frame
From inclusion to week 32
Title
Cumulative dosages of GCs at Week 32
Description
dosages of GCs
Time Frame
Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Devauchelle-Pensec, Pr
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Nord service de rhumatologie-Franche Comté
City
Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
CIC Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre hospitalier Sud-Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
CHU Dijon
City
Dijon
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hôpital européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Ch Des Pays de Morlaix
City
Morlaix
ZIP/Postal Code
29600
Country
France
Facility Name
CH Mulhouse
City
Mulhouse
Country
France
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
hôpital Sapêtrière -APHP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
CHU St Etienne
City
St Etienne
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36125471
Citation
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.
Results Reference
derived

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

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