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Biobank for Inflammatory Chronic Diseases and Osteoporosis

NCT ID: NCT05039216

Last Updated: 2024-12-11

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

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-13

Study Completion Date

2031-09-01

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Psoriatic Arthritis Spondyloarthritis Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients initiating a biotherapy or a target treatment

Blood sampling

Blood sampling

Intervention Type BIOLOGICAL

4 tubes of 7 mL will be sampled

patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology

Blood sampling

Blood sampling

Intervention Type BIOLOGICAL

4 tubes of 7 mL will be sampled

Interventions

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Blood sampling

4 tubes of 7 mL will be sampled

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeline RUYSSEN-WITRAND, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Purpan University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Adeline RUYSSEN-WITRAND, MD

Role: CONTACT

Phone: 561775626

Email: [email protected]

Delphine THUILLEZ

Role: CONTACT

Phone: 561776966

Email: [email protected]

Facility Contacts

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Adeline RUYSSEN-WITRAND, MD

Role: primary

Other Identifiers

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RC31/21/0163

Identifier Type: -

Identifier Source: org_study_id