NCT02888496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 26, 2016

Last Update Submit

August 30, 2016

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

  • Proportion of blood lymphocyte populations (T cells, B cells, NK cells)

    Lymphocyte subset analysis by flow cytometry

    6 months

Secondary Outcomes (1)

  • Serum cytokine concentration measurement

    6 months

Study Arms (2)

PMR patients

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

Drug: tocilizumab

Healthy controls

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

Interventions

tocilizumabDRUG

3 monthly IV infusions in PMR patients

Also known as: anti-IL-6 receptor monoclonal antibody
PMR patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PMR patients included in the TENOR study (NCT01713842).

You may qualify if:

  • PMR patient included in the TENOR study with samples available

You may not qualify if:

  • Patient not included in the TENOR study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related 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.

    PMID: 26929219BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Divi Cornec

    CHRU de Brest

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 5, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)