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Study During Pregnancy of Expression of miRNAs in RA or SLE

Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02350491
Acronym
SPIRALE
Enrollment
50
Registered
2015-01-29
Start date
2017-12-17
Completion date
2018-10-14
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Systemic Lupus Erythematosus

Keywords

Pregnancy, miRNA, Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)

Brief 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. 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.

Interventions

collection of biologic samples ( blood and urine) befor and after woman pregnacy

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* ACR criteria for SLE or 2010 ACR criteria for RA * Absence of any known disease (control group) * Pregnancy

Exclusion criteria

* Age \<18 * Other(s) disease(s) that might affect the course of pregnancy (diabetes, uncontrolled hypertension, moderate to severe renal, cardiac or function impairment)

Design outcomes

Primary

MeasureTime frameDescription
To identify the association between pregnancy-induced changes in the pattern of expression of miRNA and disease activity in RA and SLE.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 deliveryThe samples that will be analyzed in the present application are serum, urine, placenta, blood monocytes.

Countries

France

Contacts

STUDY_CHAIRJean SIBILIA, MD, PhD

University Hospital, Strabourg - France

STUDY_DIRECTORJacques-Eric GOTTENBERG, Md, PhD

niversity Hospital, Strabourg - France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026