Biobank for Inflammatory Chronic Diseases and Osteoporosis

Rheumatoid Arthritis Clinical Trial

— BIOTOUL  

Official title:

Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05039216
• Other study ID #: RC31/21/0163
• Status: Recruiting
• Start date: September 13, 2021
• Est. completion date: September 1, 2031

Study information

• Verified date: November 2023
• Source: University Hospital, Toulouse
• Contact: Adeline RUYSSEN-WITRAND, MD
• Phone: 561775626
• Email: ruyssen-witrand.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 1, 2031
• Est. primary completion date: September 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Chronic Disease
• Osteoporosis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

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

Locations

Country	Name	City	State
France	Purpan University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EULAR response after 3 months	EULAR response after 3 months	after 3 months