Study During Pregnancy of Expression of miRNAs in RA or SLE

NCT02350491 | Completed

• 1 other identifier: 5860
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Systemic Lupus Erythematosus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (3)

RA group

Pregnant women suffering from Rheumatoid Arthritis.

Other: Collection of biological samples

SLE group

Pregnant women suffering from Systemic Lupus Erythematosus.

Other: Collection of biological samples

healthy group

Healthy pregnant woman.

Other: Collection of biological samples

Interventions

Collection of biological samples OTHER

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

RA group; SLE group; healthy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women suffering from RA or SLE compared wiht pregnant woman in good health

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de rhumatologie Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Related Publications (1)

• 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.

  PMID: 41552363 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The samples that will be analyzed in the present application are serum, urine, placenta, blood monocytes.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean SIBILIA, MD, PhD

  University Hospital, Strabourg - France

  STUDY CHAIR

• Jacques-Eric GOTTENBERG, Md, PhD

  niversity Hospital, Strabourg - France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: December 17, 2017
• Primary Completion: October 14, 2018
• Study Completion: October 14, 2018
• Last Updated: February 3, 2026

Record last verified: 2017-12

Locations

FR (1)