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Recruiting NCT05039216

Biobank for Inflammatory Chronic Diseases and Osteoporosis

Observational Rheumatoid Arthritis Psoriatic Arthritis Spondyloarthritis Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis, Osteoporosis. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse

Overview

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.

Interventions

  • Biological Blood sampling
    4 tubes of 7 mL will be sampled

Primary outcome measures

  • EULAR response after 3 months [Time frame: after 3 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Purpan University Hospital — Toulouse

Identifiers

NCT: NCT05039216 · RC31/21/0163

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗