Clinical trial NCT02350491: Study During Pregnancy of Expression of miRNAs in RA or SLE
Official title: Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Systemic Lupus Erythematosus
Keywords: Pregnancy
miRNA
Rheumatoid Arthritis (RA)
Systemic Lupus Erythematosus (SLE)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women suffering from RA or SLE compared wiht pregnant woman in good health

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.


Eligibility criteria: 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)

Primary outcomes:
measure: To identify the association between pregnancy-induced changes in the pattern of expression of miRNA and disease activity in RA and SLE.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de rhumatologie Hôpital de Hautepierre
Study officials:
affiliation: University Hospital, Strabourg - France
name: Jean SIBILIA, MD, PhD
role: STUDY_CHAIR
affiliation: niversity Hospital, Strabourg - France
name: Jacques-Eric GOTTENBERG, Md, PhD
role: STUDY_DIRECTOR
References: