Rheumatoid ArthritisBIOTOULNCT05039216
Biobank for Inflammatory Chronic Diseases and Osteoporosis
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis
- What is being tested?
- Blood sampling
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2021to 1 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: monocentric observational longitudinal study
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding
- Not able to give a consent
- Severe anemia (Hb<10g/L)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Purpan University Hospital
Toulouse, 31059
Adeline RUYSSEN-WITRAND, MD, 561775626 ext. 0033, ruyssen-witrand.a@chu-toulouse.fr
About this study
Official title: Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse
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.
Read the 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.
- Being tested
- Blood sampling
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylarthritis, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
4 tubes of 7 mL will be sampled
| Study group | Role | What they receive |
|---|---|---|
| patients initiating a biotherapy or a target treatment | Blood sampling Receives: Biological: Blood sampling | |
| patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology | Blood sampling Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
EULAR response after 3 months
EULAR response after 3 months
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start13 Sep 2021
- Primary completion2 Sep 2026 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline RUYSSEN-WITRAND, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039216
- Sponsor's protocol ID
- RC31/21/0163
- Acronym
- BIOTOUL
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse
- ClinicalTrials.gov ID
- NCT05039216
- Acronym / sponsor ID
- BIOTOUL / RC31/21/0163
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients initiating a biotherapy or a target treatment | – | Biological: Blood samplingBlood sampling |
| patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology | – | Biological: Blood samplingBlood sampling |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- monocentric observational longitudinal study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- Not able to give a consent
- Severe anemia (Hb<10g/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling4 tubes of 7 mL will be sampled | Biological | patients initiating a biotherapy or a target treatment, patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology |
Primary outcome
EULAR response after 3 months
Time frame: after 3 months
EULAR response after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adeline RUYSSEN-WITRAND, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeline RUYSSEN-WITRAND, MD (561775626 ext. 0033, ruyssen-witrand.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EULAR response after 3 months (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.