Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05033782 |
| Other study ID # |
APHP210935 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2022 |
| Est. completion date |
August 8, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Edouard Januel, MD |
| Phone |
142161975 |
| Email |
edouard.januel[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system,
affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but
previous studies highlighted that relapse rate increased during influenzae epidemics, and air
pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that
requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and
restrictive measures taken to limit contaminations have drastically decreased air pollution
and seasonal viral infections exposure, but sanitary crisis also limited care access for MS
patients (medical treatment, rehabilitation). Therefore, this particular period offers a
unique opportunity to evaluate the impact of air pollution, viral infections, and health care
access on the severity of MS.
The main objective is to evaluate the impact of air pollution and seasonal viral infections
on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary
objective will be to evaluate the impact of health care access limitations on the risk of
neurological disability accumulation.
This study will include 1500 MS patients, living in Ile de France, followed in the
neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective
observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which
is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF,
and viral infections data will come from "Santé Publique France".
A better knowledge of the impact of air pollution, viral infections, and health care access
on the course of MS will enable to better guide information to patients and public health
care decisions.
Description:
Multiple sclerosis (MS) is a common autoimmune disease of the central nervous system. The
repetition of relapses and their severity will lead in the long term to the accumulation of
disability. The risk factors for relapses are still poorly understood, but it is suspected
that air pollution and seasonal viral infections may increase the risk of relapse.
The Sars-Cov-2 virus pandemic has abruptly disrupted the daily environment, to date three
lock-down periods have been implemented, in France, to limit the spread of COVID 19, the
first was from March 17 to May 11, 2020, the second was less strict from October 30 to
December 15, 2020, and the third began April 3, 2021. The reduction in road traffic during
the first containment was accompanied in Ile de France by a 30 to 50% decrease in fine
particulate matter and nitrogen oxide air pollution compared to the previous year. The
confinements and the generalized application of barrier measures have also been associated
with a clear decrease in the circulation of seasonal viruses, in particular influenza and
viral gastroenteritis viruses, compared to the previous year.
To date, the impact of measures to prevent the spread of the Sars-CoV-2 epidemic on the risk
of MS relapse has not been studied. However, these periods offer a unique opportunity to
assess, in a quasi-experimental model, the impact of air pollution and viral infections on
the risk of MS relapse, in a context where these factors have shown large variations compared
to the usual seasonal values observed.
The pandemic has also had a profound impact on the health care system, with the corollary
that patients with chronic pathologies have had difficulty accessing care, as hospital
structures have had to deal with an unprecedented crisis, resulting in the de-scheduling of
non-urgent procedures and great difficulty in accessing in-person consultations. Numerous
uncertainties concerning the risk of severe COVID-19 in patients treated with
immune-modulators or immune-suppressors have led to the suspension or delay of the initiation
of immuno-active treatments to prevent the aggravation of the disease. To date, no study has
evaluated the impact of changes in the management of MS patients during this particular
period and to assess the impact on the progression of neurological disability.
The primary objective of the study will be to determine the impact of environmental risk
factors (air pollution, exposure to seasonal viruses) and health care access on the risk of
clinical MS relapse, in the context of the lockdown periods, compared to periods prior to the
COVID-19 pandemic.
The secondary objective will be to assess the impact of environmental risk factors (air
pollution, exposure to seasonal viruses), on the risk of accumulation of MS disability, in
the context of the lockdown periods, compared to periods prior to the COVID-19 pandemic.
This study will include patients followed in the neurology department of the Pitié
Salpêtrière Hospital in Paris for relapsing-remitting MS, and will be conducted as bellow:
Inclusion visit:
- Conducted during the patient's usual follow-up (consultation / day hospital).
- Information and collection of non-opposition by the investigating neurologist
- Clinical examination to evaluate the disability (EDSS scale), as part of the care
(systematic for all MS consultations)
- A paper questionnaire is given to the patient during the consultation. The patient will
be contacted by telephone within 15 days after the consultation by a health care staff
to collect the answers to the questionnaire.
Different sources of data will be used together:
1. Clinical data from the OFSEP registry (French Multiple Sclerosis Observatory). OFSEP is
a national registry in which neurological clinical data of MS patients are prospectively
collected.
(i) Date of first symptoms of the disease (ii) Date of diagnosis (iii) Date of disease
relapses, date of first symptoms of the relapse (iv) Neurological disability score at
each neurological assessment as assessed by the EDSS score (v) Nature, date of
initiation and discontinuation of treatment and reasons for discontinuation (vi)
Comorbidities, infectious and neoplastic complications (vii) Education level
2. Data from the telephone questionnaire:
(i) Zip code of patient's iterative residences since 2018, as well as zip code of
residence at the time of the two confinements (ii) Occupational status (iii) Occurrence
of COVID infection/date needed for hospitalization (iv) During the COVID-19 outbreak,
did the patient: avoid seeing a doctor, avoid going to health care facilities, stop
background treatment for MS. If yes to any of the questions, the change(s) was: decided
by the patient, recommended by the treating physician, recommended by the neurologist,
other (specify) (v) During the COVID-19 outbreak, did the patient stop his or her
rehabilitation care (physical therapy, speech therapy)? If yes, date of cessation,
duration, reason for cessation (planned, decided by the patient, recommended by the
rehabilitation specialist, recommended by the attending physician, recommended by the
neurologist)
3. Pollution data from approved air quality monitoring associations (AASQA): for the Ile de
France region, this is AIR PARIF, which collects the daily average exposure to fine
particles (PM10, PM2.5), ozone (O3), and nitrogen oxides (NO2) at 37 stations in the
different departments of Ile de France. The data from the station closest to each
patient's home will be analysed.
4. Data on the circulation of influenza and gastroenteritis, produced by Santé Publique
France ("Sentinelles" network, OSCOUR network, National Reference Center for Respiratory
Infections Viruses).
