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

NCT ID: NCT03917589

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-20

Study Completion Date

2020-05-18

Brief Summary

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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.

Detailed Description

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Even if two small case control studies underlined the positive effect of high dose methylprednisolone on the relapse risk in the PP period in MS, these data have to be confirmed by a larger study. The impact of such a strategy remains also uncertain concerning the risk of long term disability. In this project, the investigators will also analyze the influence of the delay of DMD reintroduction after delivery on the relapse risk but also on the risk of disability. The results will have an important role in the therapeutic management of the post-partum period in MS patients.

Conditions

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Multiple Sclerosis

Keywords

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post-partum corticosteroids relapse disease modifying drugs (DMD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with corticosteroids

Patients who have systematically been treated by high-dose corticosteroids after the delivery

No interventions assigned to this group

Patients without corticosteroids

Patients who haven't been systematically treated by high-dose corticosteroids after the delivery.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Relapsing MS patients according to MacDonald criteria 2010
* Age between 15 and 49 years old at the pregnancy
* Age between 18 and 51 years old when filling the questionnaire of the study
* At least one full pregnancy with live birth after the beginning of the MS diagnosis
* At least one neurological visit during the 12 months period after the delivery
* At least one neurological visit per year in the 12 months preceding the pregnancy
* Pregnancy must occur between 01/2007 and 01/2017 In case of several pregnancies per woman, only the first one occurring in the period will be analyzed
* Having received information on the protocol and not having expressed opposition to participating in the study.

Exclusion Criteria

* Patients who have received Immunoglobulines or plasma exchanges after the delivery in prevention of a relapse
* Patients presenting a SPMS or PPMS form at the beginning of pregnancy
* Protected persons referred to in Articles L. 1121-6 to L. 1121-9 of the code of public health (eg minors, persons deprived of liberty, ..) except nursing mothers postpartum.
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laure MICHEL, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

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Hôpital LAENNEC

Saint-Herblain, Nantes, France

Site Status

CHU Lyon

Lyon, , France

Site Status

Hôpital Pasteur 2 - CHU Nice

Nice, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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35RC18_9844_COPP-MS

Identifier Type: -

Identifier Source: org_study_id