Study During Pregnancy of Expression of miRNAs in RA or SLE

Completed

• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus
• Interventions: Other: Collection of biological samples

• Registration Number: NCT02350491
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-29
• Status Verified: 2017-12
• Study Start: 2017-12-17
• Primary Completion: 2018-10-14
• Study Completion: 2018-10-14
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA group	Collection of biological samples	Pregnant women suffering from Rheumatoid Arthritis.
healthy group	Collection of biological samples	Healthy pregnant woman.
SLE group	Collection of biological samples	Pregnant women suffering from Systemic Lupus Erythematosus.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Service de rhumatologie Hôpital de Hautepierre; 🇫🇷 Strasbourg, France