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Polymyalgia RheumaticaPhase 2TENORNCT01713842

Tocilizumab Effect iN pOlymyalgia Rheumatica

A Phase 2 study testing TCZ in people with Polymyalgia Rheumatica, run by University Hospital, Brest at 3 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

Phase 1: Patients are treated with infusions of Tocilizumab (TCZ) for 3 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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Polymyalgia Rheumatica
What is being tested?
TCZ
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
3 sitesFrance
Study dates
Jul 2012to Oct 2014
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 50 years and 75 years included
  • PMR-AS > 10
  • PMR according to the Chuang criteria
  • Evolving since less than 12 months
  • Without Horton disease
  • Able to understand and accept the study
Show all 10Show fewer
  • Agree to sign the inform consent form
  • Without GC, or at least during 1 month and stop since 7 days before the inclusion.
  • Stable dose of Nonsteroidal anti-inflammatory since 4 weeks before the inclusion.
  • Birth controlled during all the study and 6 months after

Who cannot join

  • Disagree to participated
  • Unable to understand the study
  • Participation to an other study in the 3 months before the inclusion
  • Treated by GC at 0.3mg/kg/d in the past 7 days
  • Less than 50 years old or more than 75 years old
  • Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
Show all 29Show fewer
  • Histories of important allergy
  • Historically positive test or test positive at screening for HIV-1 antibody, hepatitis B surface antigen, or hepatitis C antibody.
  • Abnormal screening blood test : leukocyte count less than 3.5 × 109 cells/L, neutrophil count less than 2 × 109 cells/L, hemoglobin level less than 85 g/L, platelet count less than 100 × 109 cells/L, or hepatic aminotransferase or alkaline phosphatase levels greater than 3 times the upper limit of normal
  • Other inflammatory rheumatic disease or connective disease
  • Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR (eg. Cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases)
  • Current drug or alcohol abuse
  • Patients treated with an immunosuppressive agents in the past 4 weeks
  • Live/attenuated vaccine in the past 4 weeks
  • Clinical symptoms of giant cell arteritis
  • History of infection or infestation in the past 3 months
  • Active tuberculosis
  • Planned surgical procedure
  • History of malignant neoplasm within the last 5 years, except for adequately treated cancer of the skin (basal or squamous cell)
  • History or current tumoral hematological disease
  • Severe allergic or anaphylactic reactions about one of the TCZ component
  • Pregnant women during the study and six month after the end of the study
  • Breast feeding mother
  • Dysthyroidia
  • Unstable treatment by statin in the past 3 months
  • Parkinson disease
  • Fibromyalgia
  • Peripheric arthritis
  • Articular chondrocalcinosis or hydorxyapatites rhumatisms

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Brest University Hospital

    Brest, 29609

  • Nantes University Hospital

    Nantes, 44000

  • CHR d'Orléans

    Orléans, France, 45000

Other trials in France

About this study

Official title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

Phase 1:

Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is performed using PMR-AS.

Read more

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).

At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.

Phase 2:

All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .

Being tested
TCZ
Keywords
Tocilizumab, Polymyalgia Rheumatica, Glucocorticotherapy, PMR-AS
Medical subject headings
Polymyalgia Rheumatica

What participants receive

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

  • TCZDrug

    Tocilizumab at week 0, 4 and 8.

Study groups in NCT01713842
Study groupRoleWhat they receive
TCZExperimentalTocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion
Receives: Drug: TCZ

What is being measured

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

  1. Efficacy at W12

    PMR-AS at week 12

    Measured: 12 Weeks

Secondary outcomes (1)

  1. Safety and efficacy during the study

    • To maintain low disease activity (PMR-AS) in the low corticosteroid dose group from W12 to W24
    • On the inflammatory changes (synovitis, myositis, tenosynovitis aund bursitis) between baseline, W2 and 12 visualize by ultrasonography, MRI and Tep-Scan.
    • On sparing corticosteroid, with the comparison of the cumulative corticosteroid dosage beetwen the two groups of patients in the phase 2, W12 to 24.
    • On the circulating serum cytokines and immunoregulators (IL-6, IL-1, BLyS/BAFF, IL-6 receptor, gp130) and B cells receptors and on the phenotype of circulating T- and B-cells between baseline and W4 and 12 On inflammatory parameters (CRP and ESR) between baseline and W 2,4,8,12,16,20 and 24
    • On the quality of life of patients between baseline and W 4,12,16, 20 and 24
    • To evaluate the side-effects in relation to the use of Tocilizumab treatment. [ Time Frame: After first, second and third treatment and during follow up ]

    Measured: Week 2,4,8,12,16,20 and 24

Timeline

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

  1. First posted25 Oct 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01713842
Sponsor's protocol ID
RB 11-075 TENOR
Acronym
TENOR
Status last verified
Jan 2015
First submitted
17 Sep 2012
Last updated
11 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Carvajal Alegria G, Garrigues F, Bettacchioli E, Loeuille D, Saraux A, Cornec D, Devauchelle-Pensec V, Renaudineau Y. Tocilizumab controls bone turnover in early polymyalgia rheumatica. Joint Bone Spine. 2021 May;88(3):105117. doi: 10.1016/j.jbspin.2020.105117. Epub 2020 Dec 7.

    PubMed 33301930

  • Laporte JP, Garrigues F, Huwart A, Jousse-Joulin S, Marhadour T, Guellec D, Cornec D, Devauchelle-Pensec V, Saraux A. Localized Myofascial Inflammation Revealed by Magnetic Resonance Imaging in Recent-onset Polymyalgia Rheumatica and Effect of Tocilizumab Therapy. J Rheumatol. 2019 Dec;46(12):1619-1626. doi: 10.3899/jrheum.180958. Epub 2019 Mar 15.

    PubMed 30877202

  • Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.

    PubMed 26929219

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TCZ in people with Polymyalgia Rheumatica, run by University Hospital, Brest at 3 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 10 inclusion and 29 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 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Efficacy at W12 (time frame: 12 Weeks). 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 NCT01713842, which also lists 3 linked publications.

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 11 Feb 2015.

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