Biobank for Inflammatory Chronic Diseases and Osteoporosis

Recruiting

• Conditions: Spondyloarthritis; Osteoporosis; Rheumatoid Arthritis; Psoriatic Arthritis
• Interventions: Biological: Blood sampling

• Registration Number: NCT05039216
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-09
• Study Start: 2021-09-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-09-02
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients initiating a biotherapy or a target treatment	Blood sampling	Blood sampling
patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology	Blood sampling	Blood sampling

Primary Outcome Measures

Name	Time	Method
EULAR response after 3 months	after 3 months	EULAR response after 3 months

Trial Locations

Locations (1)

Purpan University Hospital; 🇫🇷 Toulouse, France