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Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica (TENOR-IMMUNO)

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ClinicalTrials.gov Identifier: NCT02888496
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
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.

Condition or disease Intervention/treatment
Polymyalgia Rheumatica Drug: tocilizumab

Detailed Description:
Comparison of PMR patients and matched control subjects.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Group/Cohort Intervention/treatment
PMR patients
Patients included in the clinical trial TENOR (prospective open-labeled study of tocilizumab in treatment-naïve PMR patients)
Drug: tocilizumab
3 monthly IV infusions in PMR patients
Other Name: anti-IL-6 receptor monoclonal antibody

Healthy controls
Matched to PMR patients for sex and age, exclusion of any autoimmune, inflammatory, neoplastic and chronic infectious disease



Primary Outcome Measures :
  1. Proportion of blood lymphocyte populations (T cells, B cells, NK cells) [ Time Frame: 6 months ]
    Lymphocyte subset analysis by flow cytometry


Secondary Outcome Measures :
  1. Serum cytokine concentration measurement [ Time Frame: 6 months ]
    Cytokine level measurements using an array and ELISAs


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
PMR patients included in the TENOR study (NCT01713842).
Criteria

Inclusion Criteria:

  • PMR patient included in the TENOR study with samples available

Exclusion Criteria:

  • Patient not included in the TENOR study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888496


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Study Director: Divi Cornec CHRU de Brest

Publications:
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02888496     History of Changes
Other Study ID Numbers: TENOR-IMMUNO
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases