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NCT02888496 Clinical Trial

Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

Polymyalgia Rheumatica Clinical Trial

— TENOR-IMMUNO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02888496
Other study ID # TENOR-IMMUNO
Secondary ID
Status Completed
Phase N/A
First received August 26, 2016
Last updated August 30, 2016
Start date January 2015
Est. completion date June 2015

Study information
Verified date August 2016
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial 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.

Description:

Comparison of PMR patients and matched control subjects.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- PMR patient included in the TENOR study with samples available

Exclusion Criteria:

- Patient not included in the TENOR study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• tocilizumab
3 monthly IV infusions in PMR patients

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of blood lymphocyte populations (T cells, B cells, NK cells) Lymphocyte subset analysis by flow cytometry 6 months No
Secondary Serum cytokine concentration measurement Cytokine level measurements using an array and ELISAs 6 months No
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