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

• ClinicalTrials.gov Identifier: NCT03917589
• Recruitment Status: Completed
• First Posted: April 17, 2019
• Last Update Posted: November 10, 2020
• Sponsor: Rennes University Hospital
• Information provided by (Responsible Party): Rennes University Hospital

Study Description

Brief 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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS
• Actual Study Start Date: June 20, 2019
• Actual Primary Completion Date: May 18, 2020
• Actual Study Completion Date: May 18, 2020

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Difference of the proportion of patients with >= 1 relapse between the two groups [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Difference of the proportion of patients with >= 1 relapse [ Time Frame: 6 months ]
   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
2. Difference of the annualized relapse rate [ Time Frame: 6 months ]
   Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD
3. Difference of the annualized relapse rate [ Time Frame: 1 year ]
   Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD
4. Difference of the annualized relapse rate [ Time Frame: two years ]
   Number of the annualized relapse rate after the delivery between corticosteroids or not and between early DMD vs delayed DMD
5. Difference of the time to first relapse [ Time Frame: Date of delivery ]
   Time to first relapse after delivery between corticosteroids or not and between early DMD vs delayed DMD
6. Difference of the disability progression [ Time Frame: 6 months ]
   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
7. Difference of the disability progression [ Time Frame: 1 year ]
   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
8. Difference of the disability progression [ Time Frame: 2 years ]
   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
9. Difference of percentage of with Gadolinium enhancing lesions [ Time Frame: 6 months ]
   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
10. Difference of the number of Gadolinium enhancing lesions [ Time Frame: 6 months ]
    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

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 49 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Study of Preventive use of COrticosteroids during the Post-Partum
• Accepts Healthy Volunteers: No
• 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

Criteria

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.

Contacts and Locations

Locations

France

Hôpital LAENNEC

Saint Herblain, Nantes, France, 44800

CHU Lyon

Lyon, France

Hôpital Pasteur 2 - CHU Nice

Nice, France, 06000

CHU Rennes

Rennes, France, 35033

CHU Strasbourg

Strasbourg, France, 67098

Sponsors and Collaborators

Rennes University Hospital

Investigators

• Principal Investigator: Laure MICHEL, Dr; CHU Rennes

More Information

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT03917589
• Other Study ID Numbers: 35RC18_9844_COPP-MS
• First Posted: April 17, 2019
• Last Update Posted: November 10, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:

post-partum; corticosteroids; relapse; disease modifying drugs (DMD)

Additional relevant MeSH terms:

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases