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Trial record 35 of 134 for:    Lupus AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT02350491
Recruitment Status : Recruiting
First Posted : January 29, 2015
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Systemic Lupus Erythematosus Other: Collection of biological samples

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus
Actual Study Start Date : February 16, 2015
Estimated Primary Completion Date : July 16, 2019
Estimated Study Completion Date : July 16, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. To identify the association between pregnancy-induced changes in the pattern of expression of miRNA and disease activity in RA and SLE. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
The samples that will be analyzed in the present application are serum, urine, placenta, blood monocytes.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women suffering from RA or SLE compared wiht pregnant woman in good health
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350491


Contacts
Contact: Jean Sibilia, MD, PhD : +33 (0) 388 127 954 jean.sibilia@chru-strasbourg.fr
Contact: Jacques-Eric GOTTENBERG, MD, PhD : +33 (0) 388 127 953 jacques-eric.gottenberg@chru-strasbourg.fr

Locations
France
Institut de Biologie Moléculaire et Cellulaire - CNRS UPR 9002 Withdrawn
Strasbourg, France, 67084
Service de rhumatologie Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Jean SIBILIA, MD, PhD    33 3 88 12 79 54    jean.sibilia@chru-strasbourg.fr   
Contact: Jacques-Eric GOTTENBERG, MD, PhD    33 3 88 12 79 53    jacques-eric.gottenberg@chru-strasbourg.fr   
Sponsors and Collaborators
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

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02350491     History of Changes
Other Study ID Numbers: 5860
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Strasbourg, France:
Pregnancy
miRNA
Rheumatoid Arthritis (RA)
Systemic Lupus Erythematosus (SLE)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases