Ocrelizumab 300 mg
DrugTwo doses of 300 mg infusion administered 14 days apart.
NCT Number: NCT03589105
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Centre hospitalier d'Agen; Neurologie, Agen, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two doses of 300 mg infusion administered 14 days apart.
A single does of 600 mg infusion administered 24 weeks after the initial dose.
Time frame: From Enrollment to Week 48
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.
Time frame: At Week 48
Annualized relapse rate is defined as the total number of clinical relapses divided by the number of participant-years of study treatment exposure. This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: From Enrollment to Week 48
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: At Week 48
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: From Baseline to Week 48
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: From Enrollment to Week 24 and Week 48
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: At Week 48
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: At Week 48
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Time frame: At Week 48
This outcome measure evaluates the impact of ocrelizumab on disease activity in participants with active RMS.
Time frame: At Week 24 and Week 48
This outcome measure describes the impact of ocrelizumab on patient reported outcomes (MS symptom severity, fatigue, health-related quality of life with standard and disease specific scales, work productivity, and treatment satisfaction) in active RMS patients.
Time frame: At Week 24 and Week 48
This outcome measure describes the impact of ocrelizumab on patient reported outcomes (MS symptom severity, fatigue, health-related quality of life with standard and disease specific scales, work productivity, and treatment satisfaction) in active RMS patients.
Time frame: At Week 24 and Week 48
This outcome measure describes the impact of ocrelizumab on patient reported outcomes (MS symptom severity, fatigue, health-related quality of life with standard and disease specific scales, work productivity, and treatment satisfaction) in active RMS patients.
Time frame: At Week 24 and Week 48
This outcome measure describes the impact of ocrelizumab on patient reported outcomes (MS symptom severity, fatigue, health-related quality of life with standard and disease specific scales, work productivity, and treatment satisfaction) in active RMS patients.
Time frame: At Week 24 and Week 48
This outcome measure describes the impact of ocrelizumab on patient reported outcomes (MS symptom severity, fatigue, health-related quality of life with standard and disease specific scales, work productivity, and treatment satisfaction) in active RMS patients.
Time frame: At Week 24 and Week 48
This outcome measure describes the impact of ocrelizumab on patient reported outcomes (MS symptom severity, fatigue, health-related quality of life with standard and disease specific scales, work productivity, and treatment satisfaction) in active RMS patients.
Time frame: From Baseline to Week 48
This outcome measure describes ocrelizumab safety in active RMS patients. Severity of AEs is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0)
Hoffmann-La Roche
Industry
An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis
Acronym: PRO-MSACTIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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