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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350491
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date January 26, 2015
First Posted Date January 29, 2015
Last Update Posted Date March 7, 2019
Actual Study Start Date December 17, 2017
Actual Primary Completion Date October 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2015)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The samples that will be analyzed in the present application are serum, urine, placenta, blood monocytes.
Sampling Method Non-Probability Sample
Study Population Pregnant women suffering from RA or SLE compared wiht pregnant woman in good health
Condition
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
Intervention Other: Collection of biological samples
collection of biologic samples ( blood and urine) befor and after woman pregnacy
Study Groups/Cohorts
  • RA group
    Pregnant women suffering from Rheumatoid Arthritis.
    Intervention: Other: Collection of biological samples
  • SLE group
    Pregnant women suffering from Systemic Lupus Erythematosus.
    Intervention: Other: Collection of biological samples
  • healthy group
    Healthy pregnant woman.
    Intervention: Other: Collection of biological samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 5, 2019)		 50
Original Estimated Enrollment
 (submitted: January 26, 2015)		 40
Actual Study Completion Date October 14, 2018
Actual Primary Completion Date October 14, 2018   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02350491
Other Study ID Numbers 5860
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital, Strasbourg, France
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Strasbourg, France
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Jean SIBILIA, MD, PhD University Hospital, Strabourg - France
Study Director: Jacques-Eric GOTTENBERG, Md, PhD niversity Hospital, Strabourg - France
PRS Account University Hospital, Strasbourg, France
Verification Date December 2017