PRO-MSACTIVE: 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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT03589105

Collaborator

(none)

423

Enrollment

Locations

Arm

30.4

Actual Duration (Months)

9.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Aug 6, 2018

Actual Primary Completion Date :

Feb 15, 2021

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of participants free of disease activity [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

Annualized relapse rate [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.
Percentage of participants with stable, improved, or worsened expanded disability status scale (EDSS) [From Enrollment to Week 48]
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Percentage of participants with confirmed disability progression at Week 24 (CDP24) [At Week 48]
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Mean Change in EDSS [From Baseline to Week 48]
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Percentage of relapse-free RMS participants [From Enrollment to Week 24 and Week 48]
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Percentage of participants with no T1 gadolinium-enhancing lesion and no new and/or enlarging T2 lesion as detected by brain MRI [At Week 48]
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Percentage of participants with no T1 gadolinium-enhancing lesion as detected by brain MRI [At Week 48]
This outcome measure describes the efficacy of ocrelizumab in active RMS participants.
Percentage of participants with no new and/or enlarging T2 lesion as detected by brain MRI [At Week 48]
This outcome measure evaluates the impact of ocrelizumab on disease activity in participants with active RMS.
Change in the score of MS symptom severity scale (SymptoMScreen) [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.
Change in the score of Modified Fatigue Impact Scale (MFIS) [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.
Change in the score of EuroQol 5-Dimension Questionnaire (EQ-5D-5L with Visual Analogue Scale (VAS)) for health-related quality of life [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.
Change in the score of Work Productivity and Activity Impairment scale (WPAI:SHP) [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.
Change in the score of Multiple Sclerosis International Quality Of Life Questionnaire (MusiQOL) [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.
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM-14) [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.
Percentage of Participants with Adverse Events (AE) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre hospitalier d'Agen; Neurologie	Agen	France	47923
2	CHU Amiens Hopital Sud; Neurologie	Amiens Cedex1	France	80054
3	CHU Angers, Batiement Larrey 2, Neurologie	Angers Cedex 9	France	49933
4	CHU de Besancon Hopital Jean Minjoz; Service de Neurologie	Besançon	France	25030
5	Groupe Hospitalier Pellegrin; Service de neurochirurgie B	Bordeaux	France	33076
6	CHU Brest Hopital La Cavale Blanche; Neurologie	Brest	France	29609
7	Hopital Pierre Wertheimer; Neurologie D	Bron	France	69677
8	Hopital Cote De Nacre; Unite Neurologie Generale	Caen	France	14033
9	CH Jean Rougier; Neurologie	Cahors	France	46005
10	Ch De Calais; Hopital De Jour	Calais Cedex	France	62107
11	CHMS Site Chambery; Neurologie	CHAMBERY Cedex	France	73011
12	CHU Hopital Gabriel Montpied; Service de Neurologie	Clermont Ferrand	France	63003
13	Hôpital General - Service de neurologie; Service de neurologie	Dijon Cedex	France	21079
14	CH de Gonesse; Neurologie	Gonesse	France	95503
15	CHU de Grenoble; Neurologie	La Tronche	France	38700
16	Centre hospitalier Andre Mignot; Neurologie	Le Chesnay Cedex	France	78157
17	CH Le Mans; Neurologie	Le Mans	France	72037
18	Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie	Libourne Cedex	France	33505
19	CH St Vincent de Paul	Lille	France	59000
20	Hopital Roger Salengro; Service de Neurologie	Lille	France
21	CHU Dupruytren - Limoges; Neurologie	Limoges	France	87042
22	Hopital européen de Marseille; Neurologie	Marseille	France	13003
23	CHU de la Timone - Hopital d Adultes; Service de Neurologie	Marseille	France	13005
24	Fondation Hopital Saint Joseph; Neurologie	Marseille	France	13285
25	Gh De Meaux; Neurologie	Meaux	France	77104
26	Centre hospitalier Annecy Genevois Site St Julien; Neurologie	Metz Tessy	France	74370
27	Centre hospitalier de Montlucon; Neurologie	Montlucon	France	03100
28	Hopital Gui de Chauliac; Neurologie	Montpellier	France	34295
29	Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie	Mulhouse Cedex 1	France	68070
30	Hopital Central - CHU de Nancy; Service de Neurologie	Nancy	France	54035
31	Hôpital Guillaume et René Laënnec; Service Neurologie	Nantes	France	44805
32	Hôpital Pasteur; Service de Neurologie	Nice	France	06002
33	CHU de Nîmes Hopital Caremeau; Service de Neurologie	Nimes	France	30900
34	Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire	Paris	France	75014
35	Fondation Rothschild; Service de Neurologie	Paris	France	75019
36	Hopital Saint Antoine; Neurologie	Paris	France	75571
37	CHU Poitiers - La Milétrie; Neurologie	Poitiers	France	86021
38	Centre Hospitalier de Cornouaille; Neurologie	Quimper	France	29000
39	Hopital Pontchaillou	Rennes	France	35033
40	Hôpital Charles Nicolle; Service de Neurologie	Rouen	France	76031
41	CHU Saint Etienne - Hôpital Nord; Neurologie	Saint-priest-en-jarez	France	42270
42	Hopital Civil de Strasbourg; Service de Neurologie	Strasbourg	France	67091
43	Hopital Foch; Neurologie	Suresnes	France	92151
44	HIA de Toulon hôpital militaire; Neurologie	Toulon	France	83041
45	Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie	Tourcoing Cedex	France	59208
46	Centre hospitalier de Valence; Neurologie	Valence Cedex 9	France	26953

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT03589105

Other Study ID Numbers:

ML40359
2018-000780-91

First Posted:

Jul 17, 2018

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Ocrelizumab

Study Results

No Results Posted as of Jan 11, 2022