Rheumatoid ArthritisLYSLUNGNCT04284735
Lysophosphatidic Acid / Autotaxin Axis in Rheumatoid Lung Disease
A study testing Quantitative ATX and LPA determination in plasma and sputum in people with Rheumatoid Arthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Rheumatoid arthritis (RA) is a common chronic systemic autoimmune relapsing disease characterized by joint inflammation. Beside arthritis leading to progressive joint damage and loss of function, RA is also associated to extraarticular inflammatory conditions such as interstitial lung disease (ILD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Quantitative ATX and LPA determination in plasma and sputum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2021to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General inclusion criteria
- Subject aged ≥ 18 and ≤ 70 years
- Patient with RA with ACPA in the state phase, meeting ACR / EULAR 2010 criteria
- For female subjects:
- Likely to procreate: negative pregnancy test at the inclusion visit and use of an effective method of contraception (hormonal contraceptives, intrauterine devices, vasectomized partner, abstinence) started at least 1 month before inclusion and continued during the entire study.
- Inability to procreate: menopause (absence of a rule for at least 1 year) or hysterectomy or bilateral oophorectomy or tubal ligation.
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- Subject having given written consent to participate in the study
- Subject affiliated to the Social Security scheme or benefiting from an equivalent scheme
- Additional inclusion criteria for cases (RA patients with PID):
- PID is defined as damage compatible with the thoracic scanner in thin sections according to international criteria with or without associated clinical signs.
- Additional inclusion criteria for control patients (RA patients without symptomatology without PID)
- No functional lung complaints
Who cannot join
- General exclusion criteria
- Vulnerable patient within the meaning of current French legislation (deprived of liberty by judicial or administrative decision, under guardianship or curatorship or under the protection of justice)
- Patient not fluent in French
- Woman breastfeeding or planning a pregnancy for the duration of the study
- Patient in exclusion period after participating in another clinical trial or in the process of participating in another clinical trial involving an experimental product
- Patient with occupational exposure to particles known to be responsible for PID (silica, etc.)
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- Patient with an autoimmune disease other than RA or an auto-inflammatory disease
- Non-inclusion criteria for cases (RA patients with PID):
- Patient with a history of asthma, COPD or any other pulmonary pathology or pulmonary symptom unrelated to PID
- Non-inclusion criteria for control patients (RA patients without PID)
- Patient with a history of asthma, COPD, any other pulmonary pathology, any pulmonary symptom or any pulmonary CT abnormality.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite
Fabienne COURY-LUCAS, MD, 04 78 86 56 95 ext. +33, fabienne.coury@chu-lyon.fr
Fabienne COURY-LUCAS, MD
About this study
Official title: Role of Lysophosphatidic Acid and Autotaxin in Rheumatoid Arthritis-associated Interstitial Lung Disease
Rheumatoid arthritis (RA) is a common chronic systemic autoimmune relapsing disease characterized by joint inflammation. Beside arthritis leading to progressive joint damage and loss of function, RA is also associated to extraarticular inflammatory conditions such as interstitial lung disease (ILD). This one develops in 30% of all RA patients with a median survival expectancy of 3 to 10 years once symptomatic. Unfortunately, there is no medical care recommendation so far as the pathophysiology is unknown. However, ILD share many similarities with idiopathic pulmonary fibrosis (IPF).
Autotaxin (ATX), due to its lysophospholipase activity, produces a bioactive lipid, lysophosphatidic acid (LPA) under inflammation. LPA has pleiotropic actions inducing cell proliferation, survival, motility and differentiation. Increased ATX and LPA levels have been detected in synovial fluid of RA patients and in IPF patients. ATX is also currently the target for a phase 3 clinical trial in IPF.
Given the previous described role of ATX/LPA axis in arthritis and inflammation-induced bone loss in RA and the similarities between RA-ILD and IPF, the investigators hypothesized that ATX/LPA axis may be also an attractive drug target for this pulmonary condition in RA and therefore that ATX and LPA may be increased in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Quantitative ATX and LPA determination in plasma and sputum
- Keywords
- Rheumatoid arthritis, Interstitial lung disease, Autotaxin, Lysophosphatidic acid
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative ATX and LPA determination in plasma and sputumOther
Determination of ATX and LPA levels in plasma and sputum from RA-ILD patients ("cases") and in plasma and sputum from RA patients without ILD ("controls") after sputum induction using hypertonic saline inhalation
| Study group | Role | What they receive |
|---|---|---|
| Controls | Other | Patients with RA and without ILD Receives: Other: Quantitative ATX and LPA determination in plasma and sputum |
| Cases | Other | Patients with RA and ILD Receives: Other: Quantitative ATX and LPA determination in plasma and sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATX and LPA levels in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD
All the samples will be frozen and ATX and LPA levels will be assessed in the plasma and sputum at the same time, at the end of the recruitment.
Measured: Month 30
Secondary outcomes (1)
Correlation between ATX and LPA levels and severity of RA-ILD estimated by tomodensitometry
Determine the correlation between ATX and LPA levels and the severity of CT scan pulmonary involvement*.
*Diffuse interstitial lung disease is defined as an attack compatible with the thoracic scanner in thin sections according to international criteria with or without associated clinical signs.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start3 Mar 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (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 Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne COURY-LUCAS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284735
- Sponsor's protocol ID
- 69HCL19_0930
- Other IDs
- 2019-A03087-50
- Acronym
- LYSLUNG
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lysophosphatidic Acid and Autotaxin in Rheumatoid Arthritis-associated Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04284735
- Acronym / sponsor ID
- LYSLUNG / 69HCL19_0930
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Interstitial lung disease, Autotaxin, Lysophosphatidic acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 26 Feb 2020 (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.
Rheumatoid arthritis (RA) is a common chronic systemic autoimmune relapsing disease characterized by joint inflammation. Beside arthritis leading to progressive joint damage and loss of function, RA is also associated to extraarticular inflammatory conditions such as interstitial lung disease (ILD). This one develops in 30% of all RA patients with a median survival expectancy of 3 to 10 years once symptomatic. Unfortunately, there is no medical care recommendation so far as the pathophysiology is unknown. However, ILD share many similarities with idiopathic pulmonary fibrosis (IPF).
Autotaxin (ATX), due to its lysophospholipase activity, produces a bioactive lipid, lysophosphatidic acid (LPA) under inflammation. LPA has pleiotropic actions inducing cell proliferation, survival, motility and differentiation. Increased ATX and LPA levels have been detected in synovial fluid of RA patients and in IPF patients. ATX is also currently the target for a phase 3 clinical trial in IPF.
Given the previous described role of ATX/LPA axis in arthritis and inflammation-induced bone loss in RA and the similarities between RA-ILD and IPF, the investigators hypothesized that ATX/LPA axis may be also an attractive drug target for this pulmonary condition in RA and therefore that ATX and LPA may be increased in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Other | Other: Quantitative ATX and LPA determination in plasma and sputumPatients with RA and without ILD |
| Cases | Other | Other: Quantitative ATX and LPA determination in plasma and sputumPatients with RA and ILD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General inclusion criteria
- Subject aged ≥ 18 and ≤ 70 years
- Patient with RA with ACPA in the state phase, meeting ACR / EULAR 2010 criteria
- For female subjects:
- Subject having given written consent to participate in the study
Key exclusion criteria (11 listed)
- General exclusion criteria
- Vulnerable patient within the meaning of current French legislation (deprived of liberty by judicial or administrative decision, under guardianship or curatorship or under the protection of justice)
- Patient not fluent in French
- Woman breastfeeding or planning a pregnancy for the duration of the study
- Patient in exclusion period after participating in another clinical trial or in the process of participating in another clinical trial involving an experimental product
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 |
|---|---|---|
| Quantitative ATX and LPA determination in plasma and sputumDetermination of ATX and LPA levels in plasma and sputum from RA-ILD patients ("cases") and in plasma and sputum from RA patients without ILD ("controls") after sputum induction using hypertonic saline inhalation | Other | Cases, Controls |
Primary outcome
ATX and LPA levels in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD
Time frame: Month 30
All the samples will be frozen and ATX and LPA levels will be assessed in the plasma and sputum at the same time, at the end of the recruitment.
1 secondary outcome
Correlation between ATX and LPA levels and severity of RA-ILD estimated by tomodensitometry
Time frame: Month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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. This study is not recruiting at the moment.
Fabienne COURY-LUCAS, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative ATX and LPA determination in plasma and sputum in people with Rheumatoid Arthritis, run by Hospices Civils de Lyon 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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne COURY-LUCAS, MD (04 78 86 56 95 ext. +33, fabienne.coury@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATX and LPA levels in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD (time frame: Month 30). 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 27 Jul 2021.