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Trial record 3 of 15 for:    ocrelizumab | Multiple Sclerosis | France

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 25, 2020
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
Allocation: N/A
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 : October 31, 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


Locations
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France
Centre hospitalier d'Agen; Neurologie
Agen, France, 47923
Centre Hospitalier d'Aix CPHA; Neurologie
Aix En Provence, France, 13616
CHU Amiens Hopital Sud; Neurologie
Amiens Cedex1, France, 80054
CHU Angers, Batiement Larrey 2, Neurologie
Angers Cedex 9, France, 49933
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Besançon, France, 25030
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Bordeaux, France, 33076
CHU Brest Hopital La Cavale Blanche; Neurologie
Brest, France, 29609
Hopital Pierre Wertheimer; Neurologie D
Bron, France, 69677
Hopital Cote De Nacre; Unite Neurologie Generale
Caen, France, 14033
CH Jean Rougier; Neurologie
Cahors, France, 46005
Ch De Calais; Hopital De Jour
Calais Cedex, France, 62107
Clinique du Parc; Cabinet de Neurologie
Castelnau Le Lez, France, 34170
CHMS Site Chambery; Neurologie
CHAMBERY Cedex, France, 73011
CHU Hopital Gabriel Montpied; Service de Neurologie
Clermont Ferrand, France, 63003
Hôpital General - Service de neurologie; Service de neurologie
Dijon Cedex, France, 21079
CH de Gonesse; Neurologie
Gonesse, France, 95503
CHU de Grenoble; Neurologie
La Tronche, France, 38700
Centre hospitalier Andre Mignot; Neurologie
Le Chesnay Cedex, France, 78157
CH Le Mans; Neurologie
Le Mans, France, 72037
Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie
Libourne Cedex, France, 33505
CH St Vincent de Paul
Lille, France, 59000
Hopital Roger Salengro; Service de Neurologie
Lille, France
CHU Dupruytren - Limoges; Neurologie
Limoges, France, 87042
Hopital européen de Marseille; Neurologie
Marseille, France, 13003
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, France, 13005
Fondation Hopital Saint Joseph; Neurologie
Marseille, France, 13285
Gh De Meaux; Neurologie
Meaux, France, 77104
Centre hospitalier Annecy Genevois Site St Julien; Neurologie
Metz Tessy, France, 74370
Centre hospitalier de Montlucon; Neurologie
Montlucon, France, 03100
Hopital Gui de Chauliac; Neurologie
Montpellier, France, 34295
Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie
Mulhouse Cedex 1, France, 68070
Hopital Central - CHU de Nancy; Service de Neurologie
Nancy, France, 54035
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes, France, 44805
Hôpital Pasteur; Service de Neurologie
Nice, France, 06002
CHU de Nîmes Hopital Caremeau; Service de Neurologie
Nimes, France, 30900
Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire
Paris, France, 75014
Fondation Rothschild; Service de Neurologie
Paris, France, 75019
Hopital Saint Antoine; Neurologie
Paris, France, 75571
CHU Poitiers - La Milétrie; Neurologie
Poitiers, France, 86021
Centre Hospitalier de Cornouaille; Neurologie
Quimper, France, 29000
Hopital Pontchaillou
Rennes, France, 35033
Hôpital Charles Nicolle; Service de Neurologie
Rouen, France, 76031
CHU Saint Etienne - Hôpital Nord; Neurologie
Saint-priest-en-jarez, France, 42270
Hopital Civil de Strasbourg; Service de Neurologie
Strasbourg, France, 67091
Hopital Foch; Neurologie
Suresnes, France, 92151
HIA de Toulon hôpital militaire; Neurologie
Toulon, France, 83041
Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie
Tourcoing Cedex, France, 59208
Centre hospitalier de Valence; Neurologie
Valence Cedex 9, France, 26953
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    
Other Study ID Numbers: ML40359
2018-000780-91 ( EudraCT Number )
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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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
Ocrelizumab
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs