PRO-MSACTIVE
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Percentage of participants free of disease activity
From Enrollment to Week 48
RelapsesMRI lesionsProportion of patients free of disease activity, defined as follow:
Other measures (16)
Annualized relapse rate
At Week 48
RelapsesPercentage of participants with stable, improved, or worsened expanded disability status scale (EDSS)
From Enrollment to Week 48
Disability progressionPercentage of participants with confirmed disability progression at Week 24 (CDP24)
At Week 48
Disability progressionMean Change in EDSS
From Baseline to Week 48
Disability progressionPercentage of relapse-free RMS participants
From Enrollment to Week 24 and Week 48
RelapsesPercentage of participants with no T1 gadolinium-enhancing lesion and no new and/or enlarging T2 lesion as detected by brain MRI
At Week 48
MRI lesionsPercentage of participants with no T1 gadolinium-enhancing lesion as detected by brain MRI
At Week 48
MRI lesionsPercentage of participants with no new and/or enlarging T2 lesion as detected by brain MRI
At Week 48
MRI lesionsChange in the score of MS symptom severity scale (SymptoMScreen)
At Week 24 and Week 48
FatigueQuality of life (reported by participants)Change in the score of Modified Fatigue Impact Scale (MFIS)
At Week 24 and Week 48
FatigueQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Results
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.
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History
Started
Aug 2018
Main results due
Feb 2021
Finished
Feb 2021
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