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

NCT03917589 | Completed

• 1 other identifier: 35RC18_9844_COPP-MS
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Difference of the proportion of patients with >= 1 relapse

  6 months

• Difference of the annualized relapse rate

  6 months

• Difference of the annualized relapse rate

  1 year

• Difference of the annualized relapse rate

  two years

• Difference of the time to first relapse

  Date of delivery

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Study of Preventive use of COrticosteroids during the Post-Partum
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (5)

Hôpital LAENNEC

Saint-Herblain, Nantes, 44800, France

Location

CHU Lyon

Lyon, France

Location

Hôpital Pasteur 2 - CHU Nice

Nice, 06000, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHU Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laure MICHEL, Dr

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: June 20, 2019
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)