Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

NCT ID: NCT02888496

Last Updated: 2016-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Comparison of PMR patients and matched control subjects.

Conditions

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Polymyalgia Rheumatica

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PMR patients

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

tocilizumab

Intervention Type DRUG

3 monthly IV infusions in PMR patients

Healthy controls

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

No interventions assigned to this group

Interventions

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tocilizumab

3 monthly IV infusions in PMR patients

Intervention Type DRUG

Other Intervention Names

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anti-IL-6 receptor monoclonal antibody

Eligibility Criteria

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Inclusion Criteria

* PMR patient included in the TENOR study with samples available

Exclusion Criteria

* Patient not included in the TENOR study
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Divi Cornec

Role: STUDY_DIRECTOR

CHRU de Brest

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 26929219 (View on PubMed)

Other Identifiers

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TENOR-IMMUNO

Identifier Type: -

Identifier Source: org_study_id

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