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Completed

NCT Number: NCT03917589

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

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Key information

Conditions

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

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital LAENNEC, Saint-Herblain, Nantes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: COPP-MS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2019
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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