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OpenTrials
Completed

NCT Number: NCT03589105

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre hospitalier d'Agen; Neurologie, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ocrelizumab 300 mg

Drug

Two doses of 300 mg infusion administered 14 days apart.

Ocrelizumab 600 mg

Drug

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

Primary outcomes

  1. Percentage of participants free of disease activity

    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.

Secondary outcomes

  1. Annualized relapse rate

    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.

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

    Time frame: From Enrollment to Week 48

    This outcome measure describes the efficacy of ocrelizumab in active RMS participants.

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

    Time frame: At Week 48

    This outcome measure describes the efficacy of ocrelizumab in active RMS participants.

  4. Mean Change in EDSS

    Time frame: From Baseline to Week 48

    This outcome measure describes the efficacy of ocrelizumab in active RMS participants.

  5. Percentage of relapse-free RMS participants

    Time frame: From Enrollment to Week 24 and Week 48

    This outcome measure describes the efficacy of ocrelizumab in active RMS participants.

  6. Percentage of participants with no T1 gadolinium-enhancing lesion and no new and/or enlarging T2 lesion as detected by brain MRI

    Time frame: At Week 48

    This outcome measure describes the efficacy of ocrelizumab in active RMS participants.

  7. Percentage of participants with no T1 gadolinium-enhancing lesion as detected by brain MRI

    Time frame: At Week 48

    This outcome measure describes the efficacy of ocrelizumab in active RMS participants.

  8. Percentage of participants with no new and/or enlarging T2 lesion as detected by brain MRI

    Time frame: At Week 48

    This outcome measure evaluates the impact of ocrelizumab on disease activity in participants with active RMS.

  9. Change in the score of MS symptom severity scale (SymptoMScreen)

    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.

  10. Change in the score of Modified Fatigue Impact Scale (MFIS)

    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.

  11. Change in the score of EuroQol 5-Dimension Questionnaire (EQ-5D-5L with Visual Analogue Scale (VAS)) for health-related quality of life

    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.

  12. Change in the score of Work Productivity and Activity Impairment scale (WPAI:SHP)

    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.

  13. Change in the score of Multiple Sclerosis International Quality Of Life Questionnaire (MusiQOL)

    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.

  14. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM-14)

    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.

  15. Percentage of Participants with Adverse Events (AE)

    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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2018
Registry last updated
Jan 11, 2022

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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