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Multiple SclerosisPhase 4PRO-MSACTIVENCT03589105

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

A Phase 4 study testing Ocrelizumab 300 mg and Ocrelizumab 600 mg in people with Multiple Sclerosis, run by Hoffmann-La Roche at 46 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab 300 mg and Ocrelizumab 600 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
423 participants
Where
46 sitesFrance
Study dates
6 Aug 2018to 15 Feb 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

France46 sites

  • Centre hospitalier d'Agen; Neurologie

    Agen, 47923

  • CHU Amiens Hopital Sud; Neurologie

    Amiens Cedex1, 80054

  • CHU Angers, Batiement Larrey 2, Neurologie

    Angers, 49933

  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

    Besançon, 25030

  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B

    Bordeaux, 33076

  • CHU Brest Hopital La Cavale Blanche; Neurologie

    Brest, 29609

  • Hopital Pierre Wertheimer; Neurologie D

    Bron, 69677

  • Hopital Cote De Nacre; Unite Neurologie Generale

    Caen, 14033

  • CH Jean Rougier; Neurologie

    Cahors, 46005

  • Ch De Calais; Hopital De Jour

    Calais, 62107

  • CHMS Site Chambery; Neurologie

    Chambéry, 73011

  • CHU Hopital Gabriel Montpied; Service de Neurologie

    Clermont-Ferrand, 63003

  • Hôpital General - Service de neurologie; Service de neurologie

    Dijon, 21079

  • CH de Gonesse; Neurologie

    Gonesse, 95503

  • CHU de Grenoble; Neurologie

    La Tronche, 38700

  • Centre hospitalier Andre Mignot; Neurologie

    Le Chesnay, 78157

  • CH Le Mans; Neurologie

    Le Mans, 72037

  • Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie

    Libourne, 33505

  • CH St Vincent de Paul

    Lille, 59000

  • Hopital Roger Salengro; Service de Neurologie

    Lille

  • CHU Dupruytren - Limoges; Neurologie

    Limoges, 87042

  • Hopital européen de Marseille; Neurologie

    Marseille, 13003

  • CHU de la Timone - Hopital d Adultes; Service de Neurologie

    Marseille, 13005

  • Fondation Hopital Saint Joseph; Neurologie

    Marseille, 13285

  • Gh De Meaux; Neurologie

    Meaux, 77104

  • Centre hospitalier Annecy Genevois Site St Julien; Neurologie

    Metz-Tessy, 74370

  • Centre hospitalier de Montlucon; Neurologie

    Montluçon, 03100

  • Hopital Gui de Chauliac; Neurologie

    Montpellier, 34295

  • Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie

    Mulhouse, 68070

  • Hopital Central - CHU de Nancy; Service de Neurologie

    Nancy, 54035

  • Hôpital Guillaume et René Laënnec; Service Neurologie

    Nantes, 44805

  • Hôpital Pasteur; Service de Neurologie

    Nice, 06002

  • CHU de Nîmes Hopital Caremeau; Service de Neurologie

    Nîmes, 30900

  • Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire

    Paris, 75014

  • Fondation Rothschild; Service de Neurologie

    Paris, 75019

  • Hopital Saint Antoine; Neurologie

    Paris, 75571

  • CHU Poitiers - La Milétrie; Neurologie

    Poitiers, 86021

  • Centre Hospitalier de Cornouaille; Neurologie

    Quimper, 29000

  • Hopital Pontchaillou

    Rennes, 35033

  • Hôpital Charles Nicolle; Service de Neurologie

    Rouen, 76031

  • CHU Saint Etienne - Hôpital Nord; Neurologie

    Saint-Priest-en-Jarez, 42270

  • Hopital Civil de Strasbourg; Service de Neurologie

    Strasbourg, 67091

  • Hopital Foch; Neurologie

    Suresnes, 92151

  • HIA de Toulon hôpital militaire; Neurologie

    Toulon, 83041

  • Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie

    Tourcoing, 59208

  • Centre hospitalier de Valence; Neurologie

    Valence, 26953

Other trials in France

About this study

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

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.

Being tested
Ocrelizumab 300 mg, Ocrelizumab 600 mg
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ocrelizumab 300 mgDrug

    Two doses of 300 mg infusion administered 14 days apart.

  • Ocrelizumab 600 mgDrug

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

Study groups in NCT03589105
Study groupRoleWhat they receive
Ocrelizumab Treatment CyclesExperimentalEach 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.
Receives: Drug: Ocrelizumab 300 mg; Drug: Ocrelizumab 600 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants free of disease activity

    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.

    Measured: From Enrollment to Week 48

Secondary outcomes (15)

  1. Annualized relapse rate

    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.

    Measured: At Week 48

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

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

    Measured: From Enrollment to Week 48

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

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

    Measured: At Week 48

  4. Mean Change in EDSS

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

    Measured: From Baseline to Week 48

  5. Percentage of relapse-free RMS participants

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

    Measured: From Enrollment to Week 24 and Week 48

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

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

    Measured: At Week 48

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

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

    Measured: At Week 48

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

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

    Measured: At Week 48

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

    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.

    Measured: At Week 24 and Week 48

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

    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.

    Measured: At Week 24 and Week 48

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

    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.

    Measured: At Week 24 and Week 48

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

    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.

    Measured: At Week 24 and Week 48

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

    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.

    Measured: At Week 24 and Week 48

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

    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.

    Measured: At Week 24 and Week 48

  15. Percentage of Participants with Adverse Events (AE)

    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)

    Measured: From Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2018
  2. Study start6 Aug 2018
  3. Primary completion15 Feb 2021
  4. Study completion15 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589105
Sponsor's protocol ID
ML40359
Other IDs
2018-000780-91, 2018
Acronym
PRO-MSACTIVE
Status last verified
Jan 2022
First submitted
5 Jul 2018
Last updated
11 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37008796

  • 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.

    PubMed 36007299

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ocrelizumab 300 mg and Ocrelizumab 600 mg in people with Multiple Sclerosis, run by Hoffmann-La Roche at 46 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants free of disease activity (time frame: From Enrollment to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589105, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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