A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting
NCT ID: NCT03589105
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
423 participants
INTERVENTIONAL
2018-08-06
2021-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ocrelizumab Treatment Cycles
Each participant will receive an initial dose of two 300 mg infusions of Ocrelizumab each separated by 14 days followed by one single dose of 600 mg 24 weeks after the initial dose.
Ocrelizumab 300 mg
Two doses of 300 mg infusion administered 14 days apart.
Ocrelizumab 600 mg
A single does of 600 mg infusion administered 24 weeks after the initial dose.
Interventions
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Ocrelizumab 300 mg
Two doses of 300 mg infusion administered 14 days apart.
Ocrelizumab 600 mg
A single does of 600 mg infusion administered 24 weeks after the initial dose.
Eligibility Criteria
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Inclusion Criteria
* Patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features: (i) at least one clinical relapse over a 6-month period prior to screening; (ii) AND/OR at least one T1 gadolinium-enhancing lesion or new and/or enlarging T2 lesion as detected by brain Magnetic Resonance Imaging (MRI) performed over a 3 months period prior to screening with no change of Disease-Modifying Treatment(s) (DMT) compared to a previous MRI performed within 24 months before screening
* For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 12 months after the last dose of ocrelizumab
* Participants should be beneficiary of healthcare coverage under the social security system
Exclusion Criteria
* Inability to complete an MRI (contraindications for MRI include but are not restricted to weight ≥140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc…)
* Gadolinium intolerance
* History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord
* History or known presence of central nervous system (CNS) or spinal cord tumor (e.g., meningioma, glioma)
* History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
* History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1 (HTLV-1), herpes zoster myelopathy)
* History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis; MELAS \[mitochondrial myopathy, encephalopathy, lactic acidosis, stroke\] syndrome)
* Neuromyelitis optica
* History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjogren's syndrome, Behçet's disease, sarcoidosis)
* History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression)
* Vulnerable patients (Patient referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Centre hospitalier d'Agen; Neurologie
Agen, , France
CHU Amiens Hopital Sud; Neurologie
Amiens Cedex1, , France
CHU Angers, Batiement Larrey 2, Neurologie
Angers, , France
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Besançon, , France
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Bordeaux, , France
CHU Brest Hopital La Cavale Blanche; Neurologie
Brest, , France
Hopital Pierre Wertheimer; Neurologie D
Bron, , France
Hopital Cote De Nacre; Unite Neurologie Generale
Caen, , France
CH Jean Rougier; Neurologie
Cahors, , France
Ch De Calais; Hopital De Jour
Calais, , France
CHMS Site Chambery; Neurologie
Chambéry, , France
CHU Hopital Gabriel Montpied; Service de Neurologie
Clermont-Ferrand, , France
Hôpital General - Service de neurologie; Service de neurologie
Dijon, , France
CH de Gonesse; Neurologie
Gonesse, , France
CHU de Grenoble; Neurologie
La Tronche, , France
Centre hospitalier Andre Mignot; Neurologie
Le Chesnay, , France
CH Le Mans; Neurologie
Le Mans, , France
Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie
Libourne, , France
CH St Vincent de Paul
Lille, , France
Hopital Roger Salengro; Service de Neurologie
Lille, , France
CHU Dupruytren - Limoges; Neurologie
Limoges, , France
Hopital européen de Marseille; Neurologie
Marseille, , France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, , France
Fondation Hopital Saint Joseph; Neurologie
Marseille, , France
Gh De Meaux; Neurologie
Meaux, , France
Centre hospitalier Annecy Genevois Site St Julien; Neurologie
Metz-Tessy, , France
Centre hospitalier de Montlucon; Neurologie
Montluçon, , France
Hopital Gui de Chauliac; Neurologie
Montpellier, , France
Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie
Mulhouse, , France
Hopital Central - CHU de Nancy; Service de Neurologie
Nancy, , France
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes, , France
Hôpital Pasteur; Service de Neurologie
Nice, , France
CHU de Nîmes Hopital Caremeau; Service de Neurologie
Nîmes, , France
Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire
Paris, , France
Fondation Rothschild; Service de Neurologie
Paris, , France
Hopital Saint Antoine; Neurologie
Paris, , France
CHU Poitiers - La Milétrie; Neurologie
Poitiers, , France
Centre Hospitalier de Cornouaille; Neurologie
Quimper, , France
Hopital Pontchaillou
Rennes, , France
Hôpital Charles Nicolle; Service de Neurologie
Rouen, , France
CHU Saint Etienne - Hôpital Nord; Neurologie
Saint-Priest-en-Jarez, , France
Hopital Civil de Strasbourg; Service de Neurologie
Strasbourg, , France
Hopital Foch; Neurologie
Suresnes, , France
HIA de Toulon hôpital militaire; Neurologie
Toulon, , France
Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie
Tourcoing, , France
Centre hospitalier de Valence; Neurologie
Valence, , France
Countries
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References
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Pau D, Lotz M, Grandclaude G, Jegou R, Civet A. Interactive statistical monitoring to optimize review of potential clinical trial issues during study conduct. Contemp Clin Trials Commun. 2023 Mar 17;33:101101. doi: 10.1016/j.conctc.2023.101101. eCollection 2023 Jun.
Manchon E, Laplaud D, Vukusic S, Labauge P, Moreau T, Kobelt G, Grouin JM, Lotz M, Pau D, Christine LF. Efficacy, safety and patient reported outcomes in patients with active relapsing multiple sclerosis treated with ocrelizumab: Final results from the PRO-MSACTIVE study. Mult Scler Relat Disord. 2022 Dec;68:104109. doi: 10.1016/j.msard.2022.104109. Epub 2022 Aug 13.
Other Identifiers
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2018-000780-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML40359
Identifier Type: -
Identifier Source: org_study_id
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