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

December 3, 2020 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Belfort, France, 90000
        • Hopital Nord service de rhumatologie-Franche Comté
      • Besançon, France, 25030
        • CHU Besançon
      • Besançon, France, 25000
        • CIC Besançon
      • Bordeaux, France, 33076
        • CHU Bordeaux
      • Brest, France, 29200
        • CHRU Brest
      • Corbeil Essonnes, France, 91106
        • Centre Hospitalier Sud-Francilien
      • Dijon, France
        • Chu Dijon
      • Le Mans, France, 72037
        • CH Le Mans
      • Marseille, France, 13003
        • Hopital Europeen
      • Morlaix, France, 29600
        • CH des Pays de Morlaix
      • Mulhouse, France
        • CH Mulhouse
      • Nancy, France, 54511
        • CHU de Nancy
      • Nantes, France, 44093
        • Chu Nantes
      • Paris, France, 75013
        • hôpital Sapêtrière -APHP
      • Rennes, France, 35203
        • CHU Rennes
      • St Etienne, France
        • CHU St Etienne
      • Strasbourg, France, 67098
        • CHRU de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Intravenous infusions of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: From week 0 to week 24
PMR-AS measure
From week 0 to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with (PMR-AS>17) in both arm
Time Frame: From Week 24 to Week 32
PMR-AS measure
From Week 24 to Week 32
PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.
Time Frame: From inclusion to week 32
PMR-AS measure
From inclusion to week 32
Cumulative dosages of GCs at Week 32
Time Frame: Week 32
dosages of GCs
Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Roche Chugai

Investigators

  • Principal Investigator: Valérie Devauchelle-Pensec, Pr, CHRU de Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

November 12, 2020

Study Completion (Actual)

November 12, 2020

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEMAPHORE (RB15.210)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polymyalgia Rheumatica

Clinical Trials on Tocilizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe