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RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis. (TRIO)

Primary Purpose

Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Perfusion of treatment Rituximab
Perfusion of treatment Ocrelizumab
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing-remitting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
  • CHRU de Brest - Hôpital la Cavale Blanche
  • Centre Hospitalier Universitaire de Caen
  • Centre Hospitalier de Pontoise - GHT NOVO
  • Hôpital Gabriel Montpieds
  • Centre hospitalier de Gonnesse
  • Groupe Hospitalier de l'Institut Catholique de Lille
  • Centre Hospitalier Universitaire de Limoges
  • AP-HM - Hôpital la Timone
  • CHRU de Montpellier - Hôpital Gui de Chauliac
  • Centre Hospitalier Régional de Nancy
  • CHU de Nantes -Hôpital Nord Laennec
  • CHU de Nice - Hôpital Pasteur 2
  • CHU de Nîmes - Hôpital Caremeau
  • AP-HP Höpital la Pitié-Salpétrière
  • Groupe Hospitalier Universitaire Henri Mondor
  • Hôpital Saint-Germain
  • Centre Hospitalier de Cornouaille
  • Centre Hospitalier Universitaire de Rennes, Hôpital PontchaillouRecruiting
  • CHU de Rouen - Hôpital Charles Nicolle
  • CHRU de Strasbourg - Hôpital Hautpierre
  • Hôpital Foch
  • CHU de Toulouse - Bâtiment Pierre Paul Riquet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ocrelizumab

Rituximab

Arm Description

Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)

Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)

Outcomes

Primary Outcome Measures

To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years.
Percentage of patients without disease activity at 2 years (Disease activity is defined as: At least one relapse between baseline and M24 OR MRI activity defined as Gd enhancing lesions at M6 or as the appearance of at least one new T2 lesion between M6 and M24)

Secondary Outcome Measures

To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Annualized relapse rate
Relapses: annualized relapse rate
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Time of onset of the first relapse
mean time of onset of the first relapse
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without relapse
Percentage of patients without relapse
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without disability progression
Percentage of patients without disability progression (Expanded Disability Status Scale-EDSS) (Disability progression will be defined as an increase of 1.5 pt if baseline EDSS=0, 1pt EDSS (if baseline 1 ≤ EDSS<6), or an increase of 0.5pt if baseline EDSS is ≥ 6; confirmed at 6 months.) EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome.
MRI parameters : gadolinium (Gd) enhancing lesions
- Mean number of Gd enhancing lesions at M6
MRI parameters : gadolinium (Gd) enhancing lesions
- Percentage of patients with at least one Gd enhancing lesion(s)
MRI parameters : Mean Number of new T2 lesions
- Mean number of new brain T2 lesions
MRI parameters : Percentage of patients with one or more new T2 lesions
- Percentage of patients with one or more new brain T2 lesions
Patients quality of life : EQ-5D-5L
Change in the EQ-5D-5L score The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Patients quality of life : MusiQOL (Multiple Sclerosis International Quality of Life questionnaire)
Change in the MusiQOL score The MusiQoL is a specific questionnaire comprising 31 questions describing nine dimensions of quality of life (Appendix 1): activities of daily living (eight items); psychological well-being (four); relationships with friends (four); symptoms (three); relationships with family (three); relationships with the health care system (three); emotional and sexual life (two); coping (two); rejection (two). Each item is scored from 1 (never/not at all) to 5 (always/very much). Before calculating the score of the dimensions, the scores of negatively written items are reversed. The score of a dimension is obtained by averaging the scores of its constituent items. The dimension scores are then transformed linearly into scores ranging from 0 to 100 (100 being the maximum quality of life level). A global quality of life score is also available.
Patients quality of life : MusiQOL
Change in the MusiQOL score The MusiQoL is a specific questionnaire comprising 31 questions describing nine dimensions of quality of life (Appendix 1): activities of daily living (eight items); psychological well-being (four); relationships with friends (four); symptoms (three); relationships with family (three); relationships with the health care system (three); emotional and sexual life (two); coping (two); rejection (two). Each item is scored from 1 (never/not at all) to 5 (always/very much). Before calculating the score of the dimensions, the scores of negatively written items are reversed. The score of a dimension is obtained by averaging the scores of its constituent items. The dimension scores are then transformed linearly into scores ranging from 0 to 100 (100 being the maximum quality of life level). A global quality of life score is also available.
Patients experience : Musicare
Change in the Musicare score Musicare is a questionnaire to assess the experience of both patients and caregivers of quality of care in MS, in accordance with psychometric standards. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3). Each item is scored from 1 (Strongly agree) to 5 (Don't know).
Patients experience : Musicare
Change in the Musicare score Musicare is a questionnaire to assess the experience of both patients and caregivers of quality of care in MS, in accordance with psychometric standards. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3). Each item is scored from 1 (Strongly agree) to 5 (Don't know).
Medico-economic impact: cost-utility ratio, QALY
Incremental Cost-Effectiveness Ratio (ICER) defined as the cost for QALY gained in "ocrelizumab group" versus "rituximab group" at 24 months.
Safety: Number of each adverse event
Number of each adverse event will be compared between the two groups
Safety: Number of each severe adverse events
Number of each severe adverse events will be compared between the two groups

Full Information

First Posted
February 17, 2023
Last Updated
August 8, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05758831
Brief Title
RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
Acronym
TRIO
Official Title
A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 31, 2030 (Anticipated)
Study Completion Date
May 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years. During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months). Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.
Detailed Description
Multiple sclerosis (MS) is an autoimmune inflammatory disease of the central nervous system (CNS). This disease is the leading cause of non-traumatic disability in young adults and France is characterized by a high prevalence (currently 1/1000 inhabitants) of MS. Clinical trials with B cell depleting therapies have shown efficacy in relapsing-remitting MS (RRMS) and are increasingly perceived as an important addition to the existing panel of Disease-modifying treatments (DMTs). Rituximab, a mouse chimeric anti CD20, is approved for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, certain forms of vasculitis and Rheumatoid Arthritis with first marketing approval in 1998. Rituximab has undergone clinical testing in RRMS in 2008 in a phase II placebo-controlled trial, demonstrating the clinico-radiological efficacy in 104 patients. Despite these promising results and the absence of adverse events, its clinical development was interrupted by the manufacturer (Roche). However, for several years, rituximab has been increasingly prescribed (off-label) in Europe and USA in patients refractory to first-line therapies, with a very good safety and efficacy. Thus, rituximab is prescribed for 40% of RRMS patients treated in Sweden. Roche has then developed a humanized anti-CD20 monoclonal antibody (Ocrelizumab). Two phase III clinical trials (OPERA I and II) have demonstrated its efficacy in active RRMS. Ocrelizumab has just been authorized in France in this indication: RRMS patients with active disease (clinical or radiological). So, it can be prescribed as a first line or second line therapy in active RRMS patients. According to literature, there are no biological arguments to think that ocrelizumab could be more effective in active RRMS compared to rituximab. Moreover, regarding safety, rituximab has been used for other indications for almost two decades and no serious concern has arisen. The high cost of this new antibody (x6 to 10) compared to rituximab) makes it wonder about its place inside the anti-CD20 therapeutic strategy compared to rituximab for treating relapsing MS patients. Hypothesis: Researchers hypothesize that rituximab and ocrelizumab have the same efficacy in active RRMS patients. Indeed, if the non-inferiority of rituximab on the % of patients without disease activity is confirmed by the trial, the potential medico-economic benefit from a societal perspective will be a strong argument to ask for authorization of rituximab in active RRMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Relapsing-remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multicenter, prospective, comparative (non inferiority), randomized, double blinded phase III/IV study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomisation code transmitted to the pharmacy preparing the treatment. Blind labelling of treatments
Allocation
Randomized
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Active Comparator
Arm Description
Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)
Arm Title
Rituximab
Arm Type
Experimental
Arm Description
Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)
Intervention Type
Drug
Intervention Name(s)
Perfusion of treatment Rituximab
Intervention Description
Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
Intervention Type
Drug
Intervention Name(s)
Perfusion of treatment Ocrelizumab
Intervention Description
Perfusion of treatment (Ocrevus®)
Primary Outcome Measure Information:
Title
To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years.
Description
Percentage of patients without disease activity at 2 years (Disease activity is defined as: At least one relapse between baseline and M24 OR MRI activity defined as Gd enhancing lesions at M6 or as the appearance of at least one new T2 lesion between M6 and M24)
Time Frame
at 2 years
Secondary Outcome Measure Information:
Title
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Annualized relapse rate
Description
Relapses: annualized relapse rate
Time Frame
at 2 years
Title
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Time of onset of the first relapse
Description
mean time of onset of the first relapse
Time Frame
at 2 years
Title
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without relapse
Description
Percentage of patients without relapse
Time Frame
at 2 years
Title
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without disability progression
Description
Percentage of patients without disability progression (Expanded Disability Status Scale-EDSS) (Disability progression will be defined as an increase of 1.5 pt if baseline EDSS=0, 1pt EDSS (if baseline 1 ≤ EDSS<6), or an increase of 0.5pt if baseline EDSS is ≥ 6; confirmed at 6 months.) EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome.
Time Frame
at 2 years
Title
MRI parameters : gadolinium (Gd) enhancing lesions
Description
- Mean number of Gd enhancing lesions at M6
Time Frame
at 6 month
Title
MRI parameters : gadolinium (Gd) enhancing lesions
Description
- Percentage of patients with at least one Gd enhancing lesion(s)
Time Frame
at 6 month
Title
MRI parameters : Mean Number of new T2 lesions
Description
- Mean number of new brain T2 lesions
Time Frame
From Month 6 to Month 24
Title
MRI parameters : Percentage of patients with one or more new T2 lesions
Description
- Percentage of patients with one or more new brain T2 lesions
Time Frame
From Month 6 to Month 24
Title
Patients quality of life : EQ-5D-5L
Description
Change in the EQ-5D-5L score The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time Frame
From baseline (Day 0) to every six month of follow up until Month 24
Title
Patients quality of life : MusiQOL (Multiple Sclerosis International Quality of Life questionnaire)
Description
Change in the MusiQOL score The MusiQoL is a specific questionnaire comprising 31 questions describing nine dimensions of quality of life (Appendix 1): activities of daily living (eight items); psychological well-being (four); relationships with friends (four); symptoms (three); relationships with family (three); relationships with the health care system (three); emotional and sexual life (two); coping (two); rejection (two). Each item is scored from 1 (never/not at all) to 5 (always/very much). Before calculating the score of the dimensions, the scores of negatively written items are reversed. The score of a dimension is obtained by averaging the scores of its constituent items. The dimension scores are then transformed linearly into scores ranging from 0 to 100 (100 being the maximum quality of life level). A global quality of life score is also available.
Time Frame
From baseline (Day 0) to Month 12
Title
Patients quality of life : MusiQOL
Description
Change in the MusiQOL score The MusiQoL is a specific questionnaire comprising 31 questions describing nine dimensions of quality of life (Appendix 1): activities of daily living (eight items); psychological well-being (four); relationships with friends (four); symptoms (three); relationships with family (three); relationships with the health care system (three); emotional and sexual life (two); coping (two); rejection (two). Each item is scored from 1 (never/not at all) to 5 (always/very much). Before calculating the score of the dimensions, the scores of negatively written items are reversed. The score of a dimension is obtained by averaging the scores of its constituent items. The dimension scores are then transformed linearly into scores ranging from 0 to 100 (100 being the maximum quality of life level). A global quality of life score is also available.
Time Frame
From baseline (Day 0) to Month 24
Title
Patients experience : Musicare
Description
Change in the Musicare score Musicare is a questionnaire to assess the experience of both patients and caregivers of quality of care in MS, in accordance with psychometric standards. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3). Each item is scored from 1 (Strongly agree) to 5 (Don't know).
Time Frame
From baseline (Day 0) to Month 12
Title
Patients experience : Musicare
Description
Change in the Musicare score Musicare is a questionnaire to assess the experience of both patients and caregivers of quality of care in MS, in accordance with psychometric standards. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3). Each item is scored from 1 (Strongly agree) to 5 (Don't know).
Time Frame
From baseline (Day 0) to Month 24
Title
Medico-economic impact: cost-utility ratio, QALY
Description
Incremental Cost-Effectiveness Ratio (ICER) defined as the cost for QALY gained in "ocrelizumab group" versus "rituximab group" at 24 months.
Time Frame
At 2 years
Title
Safety: Number of each adverse event
Description
Number of each adverse event will be compared between the two groups
Time Frame
At 2 years
Title
Safety: Number of each severe adverse events
Description
Number of each severe adverse events will be compared between the two groups
Time Frame
At 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure MICHEL, MD
Phone
0299286774
Email
laure.michel@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Gazzola
Phone
0299289194
Email
agnes.gazzola@chu-rennes.fr
Facility Information:
Facility Name
Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
City
Lyon
State/Province
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra VUKUSIC, MD
Email
sandra.vukusic@chu-lyon.fr
Facility Name
CHRU de Brest - Hôpital la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurore JOURDAIN, MD
Email
aurore.jourdain@chu-brest.fr
Facility Name
Centre Hospitalier Universitaire de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles DEFER, MD
Email
defer-gi@chu-caen.fr
Facility Name
Centre Hospitalier de Pontoise - GHT NOVO
City
Cergy-Pontoise
ZIP/Postal Code
95300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe NICLOT, MD
Email
philipe.niclot@ght-novo.fr
Facility Name
Hôpital Gabriel Montpieds
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre CLAVELOU, MD
Email
pclavelou@chu-clermont-ferrand.fr
Facility Name
Centre hospitalier de Gonnesse
City
Gonesse
ZIP/Postal Code
95503
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric MANCHON, MD
Email
eric.manchon@ch-gonessse.fr
Facility Name
Groupe Hospitalier de l'Institut Catholique de Lille
City
Lille
ZIP/Postal Code
59160
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien POUPARD, MD
Email
poupart.julien@ghicl.net
Facility Name
Centre Hospitalier Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent MAGY, MD
Email
laurent.magy@chu-limoges.fr
Facility Name
AP-HM - Hôpital la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand AUDOIN, MD
Email
bertrand.audoin@ap-hm.fr
Facility Name
CHRU de Montpellier - Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre LABAUGE, MD
Email
labauge@yahoo.fr
Facility Name
Centre Hospitalier Régional de Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MATHEY, MD
Email
g.mathey@chrudenancy.fr
Facility Name
CHU de Nantes -Hôpital Nord Laennec
City
Nantes
ZIP/Postal Code
44800
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David LAPLAUD, MD
Email
david.laplaud@chu-nantes.fr
Facility Name
CHU de Nice - Hôpital Pasteur 2
City
Nice
ZIP/Postal Code
06002
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine LEBRUN-FRENAY, MD
Email
lebrun.frenay.c@chu-nice.fr
Facility Name
CHU de Nîmes - Hôpital Caremeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric THOUVENOT, MD
Email
eric.thounevot@chu-nimes.fr
Facility Name
AP-HP Höpital la Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline LOUAPRE, MD
Email
celine.louapre@aphp.fr
Facility Name
Groupe Hospitalier Universitaire Henri Mondor
City
Paris
ZIP/Postal Code
94000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain CREANGE, MD
Email
alain.creange@aphp.fr
Facility Name
Hôpital Saint-Germain
City
Poissy
ZIP/Postal Code
78303
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier HEINZLEF, MD
Email
oheinzlef@chi-poissy-st-germain.fr
Facility Name
Centre Hospitalier de Cornouaille
City
Quimper
ZIP/Postal Code
29107
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc COUSTANS, MD
Email
m.coutains@ch-cornouaille.fr
Facility Name
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure MICHEL, MD
First Name & Middle Initial & Last Name & Degree
Laure MICHEL, PH-PD
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand BOURRE, MD
Email
bertrand.bourre@chu-rouen.fr
Facility Name
CHRU de Strasbourg - Hôpital Hautpierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme DE SEZE, MD
Email
jerome.de.seze@chru-strasbourg.fr
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TCHIKVILADZE Maia, MD
Email
m.tchikviladze@hopital-foch.com
Facility Name
CHU de Toulouse - Bâtiment Pierre Paul Riquet
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan CIRON, MD
Email
ciron.j@chu-toulouse.fr

12. IPD Sharing Statement

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RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

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