Phase
Condition
Memory Loss
Multiple Sclerosis
Scar Tissue
Treatment
Perfusion of treatment Ocrelizumab
Perfusion of treatment Rituximab
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion);
Age between 18 and 55 years
EDSS ≤ 5
Brain MRI within 6 months before inclusion
For women of childbearing potential*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate <1%, for the duration of the study and until 12 months after last dose administered) * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Having signed an informed consent form
Patients covered with social insurance
Non-Inclusion Criteria:
Secondary or primary progressive MS;
Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;
Previous treatment by fingolimod or natalizumab in the last 4 weeks;
Treatment with high dose corticosteroids during the 30 days preceding the inclusion;
Occurrence of a relapse less than 30 days before inclusion;
Pregnancy or breastfeeding;
Other neurologic or systemic disease;
Concomitant participation or Participation in another therapeutic trial in the last 6 months;
Incapacity to understand or sign the consent form;
Contraindication to MRI;
Contraindication to anti-CD20 therapies:
Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
Active malignancy.
Any ongoing infection
Severe heart failure (New York Heart Association Class IV) or severe uncontrolled cardiac disease
Positive test for HIV, hepatitis B or C, or tuberculosis
Severe immune deficiency:
Lymphopenia grade 3 (0.2 to 0.5 × 10^9/L) or higher grades
Neutropenia grade 3 (0.5 to 1.0 × 10^9/L) or higher grades
Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids
AST or ALT >=3ULN
Platelet (thrombocyte) count < 100 x 10^9/L
Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
Study Design
Study Description
Connect with a study center
Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
Lyon, Bron 69677
FranceSite Not Available
CHRU de Brest - Hôpital la Cavale Blanche
Brest, 29609
FranceSite Not Available
Centre Hospitalier Universitaire de Caen
Caen, 14033
FranceActive - Recruiting
Centre Hospitalier de Pontoise - GHT NOVO
Cergy-Pontoise, 95300
FranceSite Not Available
Hôpital Gabriel Montpieds
Clermont-Ferrand, 63003
FranceSite Not Available
Centre hospitalier de Gonnesse
Gonesse, 95503
FranceSite Not Available
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, 59160
FranceSite Not Available
Centre Hospitalier Universitaire de Limoges
Limoges, 87042
FranceSite Not Available
AP-HM - Hôpital la Timone
Marseille, 13385
FranceActive - Recruiting
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
FranceActive - Recruiting
Centre Hospitalier Régional de Nancy
Nancy, 54035
FranceActive - Recruiting
CHU de Nantes -Hôpital Nord Laennec
Nantes, 44800
FranceActive - Recruiting
CHU de Nice - Hôpital Pasteur 2
Nice, 06002
FranceActive - Recruiting
CHU de Nîmes - Hôpital Caremeau
Nîmes, 30029
FranceSite Not Available
AP-HP Höpital la Pitié-Salpétrière
Paris, 75010
FranceSite Not Available
Groupe Hospitalier Universitaire Henri Mondor
Paris, 94000
FranceSite Not Available
Hôpital Saint-Germain
Poissy, 78303
FranceSite Not Available
Centre Hospitalier de Cornouaille
Quimper, 29107
FranceActive - Recruiting
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, 35000
FranceActive - Recruiting
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76038
FranceSite Not Available
CHRU de Strasbourg - Hôpital Hautpierre
Strasbourg, 67200
FranceActive - Recruiting
Hôpital Foch
Suresnes, 92150
FranceSite Not Available
CHU de Toulouse - Bâtiment Pierre Paul Riquet
Toulouse, 31059
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.