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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 (PRO-MSACTIVE)

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ClinicalTrials.gov Identifier: NCT03589105
Recruitment Status : Active, not recruiting
First Posted : July 17, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ocrelizumab 300 mg Drug: Ocrelizumab 600 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 423 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 17, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: 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.
Drug: Ocrelizumab 300 mg
Two doses of 300 mg infusion administered 14 days apart.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589105


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03589105     History of Changes
Other Study ID Numbers: ML40359
2018-000780-91 ( EudraCT Number )
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs