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Polymyalgia RheumaticaPhase 3NCT02908217

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

A Phase 3 study testing Tocilizumab in people with Polymyalgia Rheumatica, run by University Hospital, Brest at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Polymyalgia Rheumatica
What is being tested?
Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
17 sitesFrance
Study dates
15 Feb 2017to 12 Nov 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Hopital Nord service de rhumatologie-Franche Comté

    Belfort, 90000

  • CIC Besançon

    Besançon, 25000

  • CHU Besançon

    Besançon, 25030

  • CHU Bordeaux

    Bordeaux, 33076

  • CHRU Brest

    Brest, 29200

  • Centre hospitalier Sud-Francilien

    Corbeil-Essonnes, 91106

  • CHU Dijon

    Dijon

  • CH Le Mans

    Le Mans, 72037

  • Hôpital européen

    Marseille, 13003

  • Ch Des Pays de Morlaix

    Morlaix, 29600

  • CH Mulhouse

    Mulhouse

  • CHU de Nancy

    Nancy, 54511

  • CHU Nantes

    Nantes, 44093

  • hôpital Sapêtrière -APHP

    Paris, 75013

  • CHU Rennes

    Rennes, 35203

  • CHU St Etienne

    Saint-Etienne

  • CHRU de Strasbourg

    Strasbourg, 67098

Other trials in France

About this study

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.

Being tested
Tocilizumab, Placebo
Keywords
Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid
Medical subject headings
Polymyalgia Rheumatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called Intravenous infusions of 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.

  • PlaceboDrug

    Also called Intravenous infusions of placebo

    6 Intravenous infusions of placebo every 4 weeks.

Study groups in NCT02908217
Study groupRoleWhat they receive
TocilizumabExperimental6 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.
Receives: Drug: Tocilizumab
PlaceboPlacebo comparator6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    PMR-AS measure

    Measured: From week 0 to week 24

Secondary outcomes (3)

  1. Proportion of patients with (PMR-AS>17) in both arm

    PMR-AS measure

    Measured: From Week 24 to Week 32

  2. PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.

    PMR-AS measure

    Measured: From inclusion to week 32

  3. Cumulative dosages of GCs at Week 32

    dosages of GCs

    Measured: Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion12 Nov 2020
  4. Study completion12 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02908217
Sponsor's protocol ID
SEMAPHORE (RB15.210)
Status last verified
Dec 2020
First submitted
16 Sep 2016
Last updated
4 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36125471

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab in people with Polymyalgia Rheumatica, run by University Hospital, Brest at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02908217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.

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