NCT03452735

Brief Summary

Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases. This study wants to evaluate and compare the birth rate between CIR and control group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

February 26, 2018

Last Update Submit

July 19, 2018

Conditions

Arthritis, PsoriaticArthritis, RheumatoidAnkylosing SpondylitisChronic Juvenile Arthritis

Keywords

Chronic inflammatory rheumatismFertilityProcreation

Outcome Measures

Primary Outcomes (1)

  • Birth rate after spontaneous or induced pregnancy

    Birth rate after spontaneous or induced pregnancy in women who have tried to procreate in the chronic inflammatory rheumatism group and in the control group.

    One day

Secondary Outcomes (6)

  • Rates of ectopic pregnancy, early or late spontaneous miscarriage

    one day

  • Design time

    One day

  • Birth rate according to the treatments used

    One day

  • Birth rate according to the activity of the disease

    One day

  • Rates of desire for pregnancy

    One day

  • +1 more secondary outcomes

Study Arms (2)

patients diagnosed before age 40

Patient between 18 and 50 years-old with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism who will answer to a questionnaire about fertility

Other: Questionnaire about fertility

Control Group

Patient between the ages of 18 and 50 years, not diagnosed with Chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology, presenting no chronic pathology, having no chemo or radiotherapy or immunosuppressive therapy, or pelvic surgery before age 40 years who will answer to a questionnaire about fertility

Other: Questionnaire about fertility

Interventions

Questionnaire about fertilityOTHER

Sending a questionnaire about fertility that will have to be returned to us in order to be included in the study. The questionnaires, anonymous, will be numbered according to their order of return.

Control Grouppatients diagnosed before age 40

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstudy on woman fertility
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* Case group: patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis * Control Group: patient not suffering from RIC, having consulted in rheumatology for a mechanical pathology (eg osteoarthritis, mechanical low back pain ...)

You may qualify if:

  • Patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism
  • Patient diagnosed before the age of 40
  • Patient having given her no opposition to her participation in research
  • For the control group: patient not suffering from chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology

You may not qualify if:

  • Patient\> 40 years old at the time of diagnosis
  • Patient with insufficient medical data (treatments)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Arthritis, PsoriaticArthritis, RheumatoidSpondylitis, AnkylosingArthritis, Juvenile

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisAnkylosis

Study Officials

  • Jean Parinaud, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Parinaud, MD

CONTACT

5 67 77 11 02parinaud.j@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

5 61 77 70 51olivier.i@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

July 16, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)