Rheumatoid ArthritisSPIRALENCT02350491
Study During Pregnancy of Expression of miRNAs in RA or SLE
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in osteoarticular destruction and serious disability. When clinical symptoms (painful and swollen joints) occur, the innate and adaptive immune responses against self antigens have already been largely amplified. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus
- What is being tested?
- Collection of biological samples
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2017to 14 Oct 2018
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women suffering from RA or SLE compared wiht pregnant woman in good health
Who may be able to join
- ACR criteria for SLE or 2010 ACR criteria for RA
- Absence of any known disease (control group)
- Pregnancy
Who cannot join
- Age <18
- Other(s) disease(s) that might affect the course of pregnancy (diabetes, uncontrolled hypertension, moderate to severe renal, cardiac or function impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus
Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in osteoarticular destruction and serious disability. When clinical symptoms (painful and swollen joints) occur, the innate and adaptive immune responses against self antigens have already been largely amplified. This might explain that even when RA patients are treated very early and aggressively, a remission of the disease can only be obtained in approximately half of them. This proportion of remission under treatment can only be achieved using treat to target strategies involving biologics, such as anti-TNF. Unfortunately, less than 20% of patients remain in remission after treatment discontinuation. Thus, despite the availability of 5 different types of biologics, there are still therapeutic unmet needs. However, a spontaneous, drug-free decrease of disease activity can be observed in a physiological condition, pregnancy. Although most of treatments of RA have to be discontinued during pregnancy, a marked improvement, and sometimes remission, can be observed during pregnancy, with frequent post-partum flares. The situation is the opposite with an increased risk of flares in systemic lupus erythematosus (SLE), a rare systemic autoimmune disease which generally progresses in flares-up and can affect nearly any organ (the skin, joints, kidneys, the brain, the heart, …). The course of the disease remains unpredictable for a given patient, and very few biomarkers are available to help clinicians to identify patients a risk of flares. Thus, safe therapeutic options remain limited, especially in patients with serious complications. A specific concern in SLE is the fact that the disease usually starts in women entering their sexual and reproductive life. Even with a stable condition (i.e : lupus without recent flares and no impaired renal or cardiac function) as it is medically recommended before getting pregnant, up to 40% of SLE patients flare up during pregnancy.
We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those regarding the pattern and levels of microRNAs, could explain the clinical improvement and the risk of flares in RA and SLE, respectively. A better understanding of the underlying mechanisms could help to identify new biomarkers, notably those predicting flares in SLE, and therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in RA and targeting them in SLE.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Being tested
- Collection of biological samples
- Keywords
- Pregnancy, miRNA, Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesOther
collection of biologic samples ( blood and urine) befor and after woman pregnacy
| Study group | Role | What they receive |
|---|---|---|
| RA group | Pregnant women suffering from Rheumatoid Arthritis. Receives: Other: Collection of biological samples | |
| SLE group | Pregnant women suffering from Systemic Lupus Erythematosus. Receives: Other: Collection of biological samples | |
| healthy group | Healthy pregnant woman. Receives: Other: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the association between pregnancy-induced changes in the pattern of expression of miRNA and disease activity in RA and SLE.
The samples that will be analyzed in the present application are serum, urine, placenta, blood monocytes.
Measured: Within the 3 months preceding pregnancy; at diagnosis of pregnancy; after 1 month of pregnancy; after 6 months of pregnancy; at delivery; 1 month after delivery; 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start17 Dec 2017
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean SIBILIA, MD, PhD, Study chair, University Hospital, Strabourg - FranceJacques-Eric GOTTENBERG, Md, PhD, Study director, niversity Hospital, Strabourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350491
- Sponsor's protocol ID
- 5860
- Acronym
- SPIRALE
- Status last verified
- Dec 2017
- First submitted
- 26 Jan 2015
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Scherlinger M, Schmauch E, Carapito R, Pichot A, Alsaleh G, Paul N, Molitor A, Lefebvre F, Schmidt-Mutter C, Bahram S, Sibilia J, Georgel P. Systemic lupus pregnancies are characterized by an intrinsic pro-inflammatory monocyte transcriptome, driven by an aberrant miRNA signature. J Transl Autoimmun. 2025 Dec 24;12:100347. doi: 10.1016/j.jtauto.2025.100347. eCollection 2026 Jun.
PubMed 41552363
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02350491
- Acronym / sponsor ID
- SPIRALE / 5860
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Keywords
- Pregnancy, miRNA, Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 29 Jan 2015 (estimated)
- 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 systemic disease, which mainly targets joints and results in osteoarticular destruction and serious disability. When clinical symptoms (painful and swollen joints) occur, the innate and adaptive immune responses against self antigens have already been largely amplified. This might explain that even when RA patients are treated very early and aggressively, a remission of the disease can only be obtained in approximately half of them. This proportion of remission under treatment can only be achieved using treat to target strategies involving biologics, such as anti-TNF. Unfortunately, less than 20% of patients remain in remission after treatment discontinuation. Thus, despite the availability of 5 different types of biologics, there are still therapeutic unmet needs. However, a spontaneous, drug-free decrease of disease activity can be observed in a physiological condition, pregnancy. Although most of treatments of RA have to be discontinued during pregnancy, a marked improvement, and sometimes remission, can be observed during pregnancy, with frequent post-partum flares. The situation is the opposite with an increased risk of flares in systemic lupus erythematosus (SLE), a rare systemic autoimmune disease which generally progresses in flares-up and can affect nearly any organ (the skin, joints, kidneys, the brain, the heart, …). The course of the disease remains unpredictable for a given patient, and very few biomarkers are available to help clinicians to identify patients a risk of flares. Thus, safe therapeutic options remain limited, especially in patients with serious complications. A specific concern in SLE is the fact that the disease usually starts in women entering their sexual and reproductive life. Even with a stable condition (i.e : lupus without recent flares and no impaired renal or cardiac function) as it is medically recommended before getting pregnant, up to 40% of SLE patients flare up during pregnancy.
We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those regarding the pattern and levels of microRNAs, could explain the clinical improvement and the risk of flares in RA and SLE, respectively. A better understanding of the underlying mechanisms could help to identify new biomarkers, notably those predicting flares in SLE, and therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in RA and targeting them in SLE.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RA group | – | Other: Collection of biological samplesPregnant women suffering from Rheumatoid Arthritis. |
| SLE group | – | Other: Collection of biological samplesPregnant women suffering from Systemic Lupus Erythematosus. |
| healthy group | – | Other: Collection of biological samplesHealthy pregnant woman. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women suffering from RA or SLE compared wiht pregnant woman in good health
Key inclusion criteria (3 listed)
- ACR criteria for SLE or 2010 ACR criteria for RA
- Absence of any known disease (control group)
- Pregnancy
Key exclusion criteria (2 listed)
- Age <18
- Other(s) disease(s) that might affect the course of pregnancy (diabetes, uncontrolled hypertension, moderate to severe renal, cardiac or function impairment)
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 |
|---|---|---|
| Collection of biological samplescollection of biologic samples ( blood and urine) befor and after woman pregnacy | Other | RA group, SLE group, healthy group |
Primary outcome
To identify the association between pregnancy-induced changes in the pattern of expression of miRNA and disease activity in RA and SLE.
Time frame: Within the 3 months preceding pregnancy; at diagnosis of pregnancy; after 1 month of pregnancy; after 6 months of pregnancy; at delivery; 1 month after delivery; 3 months after delivery
The samples that will be analyzed in the present application are serum, urine, placenta, blood monocytes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 41552363Scherlinger M, Schmauch E, Carapito R, Pichot A, Alsaleh G, Paul N, Molitor A, Lefebvre F, Schmidt-Mutter C, Bahram S, Sibilia J, Georgel P. Systemic lupus pregnancies are characterized by an intrinsic pro-inflammatory monocyte transcriptome, driven by an aberrant miRNA signature. J Transl Autoimmun. 2025 Dec 24;12:100347. doi: 10.1016/j.jtauto.2025.100347. eCollection 2026 Jun.
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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.
Jean SIBILIA, MD, PhD study chair
University Hospital, Strabourg - France
Jacques-Eric GOTTENBERG, Md, PhD study director
niversity Hospital, Strabourg - France
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 Systemic Lupus Erythematosus, run by University Hospital, Strasbourg, France 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 2 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: finished, as of the sponsor's last update on 3 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the association between pregnancy-induced changes in the pattern of expression of miRNA and disease activity in RA and SLE. (time frame: Within the 3 months preceding pregnancy; at diagnosis of pregnancy; after 1 month of pregnancy; after 6 months of pregnancy; at delivery; 1 month after delivery; 3 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350491, which also lists 1 linked publication.
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 3 Feb 2026.