Study During Pregnancy of Expression of miRNAs in RA or SLE (SPIRALE)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus
• Intervention / Treatment: Other: Collection of biological samples

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Service De Rhumatologie Hopital de Hautepierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RA group; Pregnant women suffering from Rheumatoid Arthritis.	Other: Collection of biological samples; collection of biologic samples ( blood and urine) befor and after woman pregnacy
SLE group; Pregnant women suffering from Systemic Lupus Erythematosus.	Other: Collection of biological samples; collection of biologic samples ( blood and urine) befor and after woman pregnacy
healthy group; Healthy pregnant woman.	Other: Collection of biological samples; collection of biologic samples ( blood and urine) befor and after woman pregnacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Study Chair: Jean SIBILIA, MD, PhD, University Hospital, Strabourg - France; Study Director: Jacques-Eric GOTTENBERG, Md, PhD, niversity Hospital, Strabourg - France

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2017
• Primary Completion (Actual): October 14, 2018
• Study Completion (Actual): October 14, 2018

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; miRNA; Rheumatoid Arthritis (RA); Systemic Lupus Erythematosus (SLE)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 5860

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No