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

Multiple Sclerosis Clinical Trial

— COPP-MS  

Official title:

Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917589
• Other study ID #: 35RC18_9844_COPP-MS
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: May 18, 2020

Study information

• Verified date: November 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
France	CHU Lyon	Lyon
France	Hôpital Pasteur 2 - CHU Nice	Nice
France	CHU Rennes	Rennes
France	Hôpital LAENNEC	Saint Herblain	Nantes
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of the proportion of patients with >= 1 relapse between the two groups	proportion of patients with >= 1 relapse during the six-month period after delivery between the patients who have systematically been treated by high-dose corticosteroids after the delivery; and patients who haven't been systematically treated by high-dose corticosteroids.	6 months
Secondary	Difference of the proportion of patients with >= 1 relapse	proportion of patients with >= 1 relapse during the six-month period after delivery between patients who have resumed a DMD early after the delivery (during the first two months) compared to a delayed reintroduction, or an absence of reintroduction	6 months
Secondary	Difference of the annualized relapse rate	Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD	6 months
Secondary	Difference of the annualized relapse rate	Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD	1 year
Secondary	Difference of the annualized relapse rate	Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD	two years
Secondary	Difference of the time to first relapse	Time to first relapse after delivery between corticosteroids or not and between early DMD vs delayed DMD	Date of delivery
Secondary	Difference of the disability progression	Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD	6 months
Secondary	Difference of the disability progression	Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD	1 year
Secondary	Difference of the disability progression	Score of Expanded Disability Status Scale (EDSS) (from 0=no disability, to 10= Death / No sub scales) between corticosteroids or not and between early DMD vs delayed DMD	2 years
Secondary	Difference of percentage of with Gadolinium enhancing lesions	Difference of percentage of with Gadolinium enhancing lesions during the 6-month period after the delivery between corticosteroids or not and between early DMD vs delayed DMD	6 months
Secondary	Difference of the number of Gadolinium enhancing lesions	compare the number of Gadolinium enhancing lesions during the 6-month period after the delivery between corticosteroids or not and between early DMD vs delayed DMD	6 months