NCT03917589

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2019-06-20
• Primary completion: 2020-05-18
• Completion: 2020-05-18
• First posted: 2019-04-17
• Last updated: 2020-11-10

Locations

5 sites across 1 country: France