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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • CHU Lyon
  • Nice, France, 06000
    • Hôpital Pasteur 2 - CHU Nice
  • Rennes, France, 35033
    • CHU Rennes
  • Strasbourg, France, 67098
    • CHU Strasbourg
  • Nantes
    • Saint Herblain, Nantes, France, 44800
      • Hôpital Laënnec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

relapsing MS patients with at least one full pregnancy with live birth between 01/2007 and 01/2017 after the beginning of the MS diagnosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with corticosteroids; Patients who have systematically been treated by high-dose corticosteroids after the delivery
Patients without corticosteroids; Patients who haven't been systematically treated by high-dose corticosteroids after the delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Laure MICHEL, Dr, CHU Rennes

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): May 18, 2020
• Study Completion (Actual): May 18, 2020

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: relapse; corticosteroids; post-partum; disease modifying drugs (DMD)
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 35RC18_9844_COPP-MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No