Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

Completed

• Conditions: Polymyalgia Rheumatica
• Interventions: Drug: tocilizumab

• Registration Number: NCT02888496
• Lead Sponsor: 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.

Detailed Description

Comparison of PMR patients and matched control subjects.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-30
• Last Update Submitted: 2016-08-30
• Study First Posted: 2016-09-05
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• PMR patient included in the TENOR study with samples available

Exclusion Criteria

• Patient not included in the TENOR study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PMR patients	tocilizumab	Patients included in the clinical trial TENOR (prospective open-labeled study of tocilizumab in treatment-naïve PMR patients)

Primary Outcome Measures

Name	Time	Method
Proportion of blood lymphocyte populations (T cells, B cells, NK cells)	6 months	Lymphocyte subset analysis by flow cytometry

Secondary Outcome Measures

Name	Time	Method
Serum cytokine concentration measurement	6 months	Cytokine level measurements using an array and ELISAs

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France