Multiple SclerosisCOPP-MSNCT03917589
Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS)
An observational study of Multiple Sclerosis, run by Rennes University Hospital at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 350 participants
- Where
- 5 sitesFrance
- Study dates
- 20 Jun 2019to 18 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Lyon
Lyon
Hôpital Pasteur 2 - CHU Nice
Nice, 06000
CHU Rennes
Rennes, 35033
Hôpital LAENNEC
Saint-Herblain, Nantes, 44800
CHU Strasbourg
Strasbourg, 67098
About this study
Official title: 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.
Read the 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
- Keywords
- post-partum, corticosteroids, relapse, disease modifying drugs (DMD)
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start20 Jun 2019
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure MICHEL, Dr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917589
- Sponsor's protocol ID
- 35RC18_9844_COPP-MS
- Acronym
- COPP-MS
- Status last verified
- Nov 2020
- First submitted
- 12 Apr 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS
- ClinicalTrials.gov ID
- NCT03917589
- Acronym / sponsor ID
- COPP-MS / 35RC18_9844_COPP-MS
- Conditions
- Multiple Sclerosis
- Keywords
- post-partum, corticosteroids, relapse, disease modifying drugs (DMD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Difference of the proportion of patients with >= 1 relapse
Time frame: 6 months
Difference of the annualized relapse rate
Time frame: 6 months
Difference of the annualized relapse rate
Time frame: 1 year
Difference of the annualized relapse rate
Time frame: two years
Difference of the time to first relapse
Time frame: Date of delivery
Difference of the disability progression
Time frame: 6 months
Difference of the disability progression
Time frame: 1 year
Difference of the disability progression
Time frame: 2 years
Difference of percentage of with Gadolinium enhancing lesions
Time frame: 6 months
Difference of the number of Gadolinium enhancing lesions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure MICHEL, Dr principal investigator
Rennes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Rennes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the proportion of patients with >= 1 relapse between the two groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.