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

NCT03589105 | Completed Phase 4

• 2 other identifiers: ML403592018-000780-91
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 46

Brief Summary

This national, open-label study is designed to give complementary efficacy, safety and patient reported outcomes (PROs) data in participants with active relapsing forms of MS. Participants will receive a maximum of 2 treatment cycles of ocrelizumab infusions: an initial dose of two 300 milligram (mg) infusions separated by 14 days followed by one single infusion of 600 mg ocrelizumab 24 weeks after the first infusion. Disease activity is determined by clinical relapses and/or Magnetic Resonance Imaging (MRI) activity.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of participants free of disease activity

  This outcome measure evaluates the impact of ocrelizumab on disease activity in participants with active Relapsing Multiple Sclerosis (RMS). Freedom of disease activity is defined as participant without any relapse from enrollment to Week 48 and without T1 Gadolinium-enhancing lesion detected by brain MRI at Week 48 and without any new and/or enlarging T2 lesion detected by brain MRI at Week 48.

  From Enrollment to Week 48

Secondary Outcomes (15)

• Annualized relapse rate

  At Week 48

• Percentage of participants with stable, improved, or worsened expanded disability status scale (EDSS)

  From Enrollment to Week 48

• Percentage of participants with confirmed disability progression at Week 24 (CDP24)

  At Week 48

• Mean Change in EDSS

  From Baseline to Week 48

• Percentage of relapse-free RMS participants

  From Enrollment to Week 24 and Week 48

Study Arms (1)

Ocrelizumab Treatment Cycles

EXPERIMENTAL

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.

Drug: Ocrelizumab 300 mg; Drug: Ocrelizumab 600 mg

Interventions

Ocrelizumab 300 mg DRUG

Two doses of 300 mg infusion administered 14 days apart.

Ocrelizumab Treatment Cycles

Ocrelizumab 600 mg DRUG

A single does of 600 mg infusion administered 24 weeks after the initial dose.

Ocrelizumab Treatment Cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/=18 years at screening
• 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

You may not qualify if:

• Diagnosis of primary progressive MS
• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (46)

Centre hospitalier d'Agen; Neurologie

Agen, 47923, France

Location

CHU Amiens Hopital Sud; Neurologie

Amiens Cedex1, 80054, France

Location

CHU Angers, Batiement Larrey 2, Neurologie

Angers, 49933, France

Location

CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

Besançon, 25030, France

Location

Groupe Hospitalier Pellegrin; Service de neurochirurgie B

Bordeaux, 33076, France

Location

CHU Brest Hopital La Cavale Blanche; Neurologie

Brest, 29609, France

Location

Hopital Pierre Wertheimer; Neurologie D

Bron, 69677, France

Location

Hopital Cote De Nacre; Unite Neurologie Generale

Caen, 14033, France

Location

CH Jean Rougier; Neurologie

Cahors, 46005, France

Location

Ch De Calais; Hopital De Jour

Calais, 62107, France

Location

CHMS Site Chambery; Neurologie

Chambéry, 73011, France

Location

CHU Hopital Gabriel Montpied; Service de Neurologie

Clermont-Ferrand, 63003, France

Location

Hôpital General - Service de neurologie; Service de neurologie

Dijon, 21079, France

Location

CH de Gonesse; Neurologie

Gonesse, 95503, France

Location

CHU de Grenoble; Neurologie

La Tronche, 38700, France

Location

Centre hospitalier Andre Mignot; Neurologie

Le Chesnay, 78157, France

Location

CH Le Mans; Neurologie

Le Mans, 72037, France

Location

Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie

Libourne, 33505, France

Location

CH St Vincent de Paul

Lille, 59000, France

Location

Hopital Roger Salengro; Service de Neurologie

Lille, France

Location

CHU Dupruytren - Limoges; Neurologie

Limoges, 87042, France

Location

Hopital européen de Marseille; Neurologie

Marseille, 13003, France

Location

CHU de la Timone - Hopital d Adultes; Service de Neurologie

Marseille, 13005, France

Location

Fondation Hopital Saint Joseph; Neurologie

Marseille, 13285, France

Location

Gh De Meaux; Neurologie

Meaux, 77104, France

Location

Centre hospitalier Annecy Genevois Site St Julien; Neurologie

Metz-Tessy, 74370, France

Location

Centre hospitalier de Montlucon; Neurologie

Montluçon, 03100, France

Location

Hopital Gui de Chauliac; Neurologie

Montpellier, 34295, France

Location

Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie

Mulhouse, 68070, France

Location

Hopital Central - CHU de Nancy; Service de Neurologie

Nancy, 54035, France

Location

Hôpital Guillaume et René Laënnec; Service Neurologie

Nantes, 44805, France

Location

Hôpital Pasteur; Service de Neurologie

Nice, 06002, France

Location

CHU de Nîmes Hopital Caremeau; Service de Neurologie

Nîmes, 30900, France

Location

Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire

Paris, 75014, France

Location

Fondation Rothschild; Service de Neurologie

Paris, 75019, France

Location

Hopital Saint Antoine; Neurologie

Paris, 75571, France

Location

CHU Poitiers - La Milétrie; Neurologie

Poitiers, 86021, France

Location

Centre Hospitalier de Cornouaille; Neurologie

Quimper, 29000, France

Location

Hopital Pontchaillou

Rennes, 35033, France

Location

Hôpital Charles Nicolle; Service de Neurologie

Rouen, 76031, France

Location

CHU Saint Etienne - Hôpital Nord; Neurologie

Saint-Priest-en-Jarez, 42270, France

Location

Hopital Civil de Strasbourg; Service de Neurologie

Strasbourg, 67091, France

Location

Hopital Foch; Neurologie

Suresnes, 92151, France

Location

HIA de Toulon hôpital militaire; Neurologie

Toulon, 83041, France

Location

Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie

Tourcoing, 59208, France

Location

Centre hospitalier de Valence; Neurologie

Valence, 26953, France

Location

Related Publications (2)

• 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.

  PMID: 37008796 DERIVED

• 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.

  PMID: 36007299 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 17, 2018
• Study Start: August 6, 2018
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

FR (46)