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OpenTrials
Completed

NCT Number: NCT02888496

Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at characterizing immunological abnormalities in PMR patients, and to assess the effects of tocilizumab therapy on this abnormalities.

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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

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

About this study

Comparison of PMR patients and matched control subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • PMR patient included in the TENOR study with samples available

Exclusion criteria

  • Patient not included in the TENOR study

Treatment and study plan

Tocilizumab

Drug

3 monthly IV infusions in PMR patients

Other names: anti-IL-6 receptor monoclonal antibody

Primary outcomes

  1. Proportion of blood lymphocyte populations (T cells, B cells, NK cells)

    Time frame: 6 months

    Lymphocyte subset analysis by flow cytometry

Secondary outcomes

  1. Serum cytokine concentration measurement

    Time frame: 6 months

    Cytokine level measurements using an array and ELISAs

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab

Acronym: TENOR-IMMUNO

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2016
Registry last updated
Sep 5, 2016

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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