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OpenTrials
Completed

NCT Number: NCT02908217

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

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.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Nord service de rhumatologie-Franche Comté, Belfort, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tocilizumab

Drug

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

Drug

6 Intravenous infusions of placebo every 4 weeks.

Other names: Intravenous infusions of placebo

Primary outcomes

  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).

    Time frame: From week 0 to week 24

    PMR-AS measure

Secondary outcomes

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

    Time frame: From Week 24 to Week 32

    PMR-AS measure

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

    Time frame: From inclusion to week 32

    PMR-AS measure

  3. Cumulative dosages of GCs at Week 32

    Time frame: Week 32

    dosages of GCs

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Roche Chugai

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2016
Registry last updated
Dec 4, 2020

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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