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Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS)

NCT03917589 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2020-11-10

No results posted yet for this study

Summary

Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.

In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.

The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.

Conditions

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Laure MICHEL, Dr · CHU Rennes

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2020-05-18
Completion
2020-05-18

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03917589 on ClinicalTrials.gov