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Clinical Trials/NCT05039216
NCT05039216
Recruiting
Not Applicable

Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse

University Hospital, Toulouse1 site in 1 country2,000 target enrollmentSeptember 13, 2021

Overview

Phase
Not Applicable
Intervention
Blood sampling
Conditions
Rheumatoid Arthritis
Sponsor
University Hospital, Toulouse
Enrollment
2000
Locations
1
Primary Endpoint
EULAR response after 3 months
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.

Detailed Description

Biologic ant targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have greatly improved the prognosis of chronic inflammatory diseases. To date, many bDMARDs and tsDMARDs targeting different immunologic mechanisms are available to treat RA, SpA or PsA. However, the choice of the treatment and its mechanism of action is based on physician decision and experience. Indeed, predictive clinical and biological factors associated with therapeutic response that could help the physician to make his/her choice are lacking. The aim of BIOTOUL is to collect and store biologic samples in patients with RA, SpA or PsA who begin a new bDMARD or tsDMARD. This biobank will permit to study several biomarkers and assess the association between such markers and response to therapy. Furthermore, osteoporosis is a chronic disease leading to fractures and disability. Several ant-osteoporotic drugs are now available and biomarker(s) that would help the physician to choose the best therapeutic sequence are lacking. BIOTOUL will also include patients with osteoporosis to identify biomarkers associated with severity and response to anti-osteoporotic treatments.

Registry
clinicaltrials.gov
Start Date
September 13, 2021
End Date
September 1, 2031
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Chronic inflammatory rheumatism including RA, SpA or PsA or patients with primary or secondary osteoporosis
  • With National Health Assurance
  • Able to consent to the study

Exclusion Criteria

  • Pregnancy or breastfeeding
  • Not able to give a consent
  • Severe anemia (Hb\<10g/L)

Arms & Interventions

patients initiating a biotherapy or a target treatment

Blood sampling

Intervention: Blood sampling

patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology

Blood sampling

Intervention: Blood sampling

Outcomes

Primary Outcomes

EULAR response after 3 months

Time Frame: after 3 months

EULAR response after 3 months

Study Sites (1)

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