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

August 30, 2016 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of PMR patients and matched control subjects.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

PMR patients included in the TENOR study (NCT01713842).

Description

Inclusion Criteria:

  • PMR patient included in the TENOR study with samples available

Exclusion Criteria:

  • Patient not included in the TENOR study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of blood lymphocyte populations (T cells, B cells, NK cells)
Time Frame: 6 months
Lymphocyte subset analysis by flow cytometry
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum cytokine concentration measurement
Time Frame: 6 months
Cytokine level measurements using an array and ELISAs
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Divi Cornec, CHRU de Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

September 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENOR-IMMUNO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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