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OpenTrials
Completed

NCT Number: NCT01713842

Tocilizumab Effect iN pOlymyalgia Rheumatica

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 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) .

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Key information

Conditions

Polymyalgia Rheumatica Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHR d'Orléans, Orléans, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

TCZ

Drug

Tocilizumab at week 0, 4 and 8.

Primary outcomes

  1. Efficacy at W12

    Time frame: 12 Weeks

    PMR-AS at week 12

Secondary outcomes

  1. Safety and efficacy during the study

    Time frame: Week 2,4,8,12,16,20 and 24

    • 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 ]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Chugai Pharmaceutical

Registry information

Official study 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)

Acronym: TENOR

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2012
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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