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Trial details
Trial details
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab
Current status:
Approved
|
Date registered:
06/06/2022
Trial version(s)
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
History: 25/03/2021
Current: 25/03/2021
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2021034775
Protocol number
COMB157G23101
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab
Acronym
Scientific title
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy
Acronym
Brief summary of the study: English
The open label study to evaluate effectiveness of treatment with ofatumumab in patients transitioning from commonly used oral MS therapies - fingolimod or dimethyl fumarate, due to breakthrough disease.
Brief summary of the study: Arabic
دراسة تقدّميّة متعددة المراكز مفتوحة اللصاقة ذات مجموعة واحدة لتقييم فعاليّة العلاج بأوفاتوموماب والنتائج التي يفيد عنها المرضى المصابين بالتصلّب اللويحي الانتكاسي الذين ينتقلون من العلاج بثنائي ميثيل الفومارات أو بفينغوليمود
Health conditions/problem studied: Specify
Relapsing Multiple Sclerosis
Interventions: Specify
Biological: Ofatumumab Patients in the ofatumumab will receive injections of ofatumumab provided in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content) Other Name: OMB157
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: Diagnosis of multiple sclerosis (MS) Relapsing MS (RRMS or SPMS) course Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug Breakthrough disease as evidence by clinical relapses or MRI EDSS score of 0 to 4
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
60
Key inclusion and exclusion criteria: Exclusion criteria
Primary progressive MS or SPMS without disease activity Disease duration of more than 10 years since diagnosis Patients with an active chronic disease of the immune system other than MS Patients at risk of developing or having reactivation of hepatitis Patients with active systemic infections or with neurological findings consistent with PML Other protocol-defined inclusion/exclusion criteria may apply
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Single Arm Study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
US, UAE, Albania, Argentina, Canada, Singapore , Switzerland, Lebanon
Name of IMP
Ofatumumab
Year of authorization
2021
Month of authorization
11
Type of IMP
Immunological
Pharmaceutical class
Monoclonal antibodies
Therapeutic indication
Patients with: relapsing multiple sclerosis
Therapeutic benefit
potential efficacy of ofatumumab in patients with relapsing MS.
Biospecimen retention
Samples without DNA
Biospecimen description
Covance Central lab : Ambient and Frozen conditions
Target sample size
10
Actual enrollment target size
3
Date of first enrollment: Type
Actual
Date of first enrollment: Date
10/08/2021
Date of study closure: Type
Actual
Date of study closure: Date
25/06/2025
Recruitment status
Recruiting
Date of completion
31/08/2022
IPD sharing statement plan
Yes
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT04353492?term=ofatumumab+treatment+effectiveness&cond=relapsing+multiple+sclerosis+transitioning&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NCT04353492
Clinical trials.gov
Sources of Monetary or Material Support
Name
Novartis Pharma services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Taghrid
El Hajj
Beirut
Lebanon
9613494008
taghridelhajj@gmail.com
Rafik Hariri University Hospital
Scientific
Hind
Khairallah
Sinelfil
Lebanon
01512002#271
Hind.khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l
Public
Halim
Abboud
Beirut
Lebanon
9613535711
halimabboud@hotmail.com
Hotel Dieu De France
Public
Salam
Koussa
Beirut
Lebanon
9613726771
drkoussa@hotmail.com
Lebanese Geitaoui Hospital
Public
Samia
Khoury
Beirut
Lebanon
9611350000#7422
sk88@aub.edu.lb
American University of Beirut Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Rafik Hariri University Hospital
Taghrid El Hajj
Neurology
Approved
Hotel Dieu De France
Halim Abboud
Neurology
Approved
Lebanese Hospital Geitaoui
Salam Koussa
Neurology
Approved
American University of Beirut Medical Center
Samia Khoury
Neurology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Rafic Hariri University Hospital
02/12/2020
Rawan Yammout
rawan.yamout@crurhuh.com
018300000 ext 2037
Hotel Dieu de France
03/11/2020
Sami Richa
cue@usj.edu.lb
961421229
Hopital Libanais Getaoui Centre Hospitalier Universitaire
23/03/2021
Raja Chaftari
irb@hopital-libanais.com
961 1 590 000 # 8872 8859
American University of Beirut Medical Center
25/05/2021
Fuad Ziyadeh
fz05@aub.edu.lb
9611350000#5445
Countries of Recruitment
Name
Lebanon
Australia
Austria
Belgium
Bulgaria
Czech Republic
Germany
Greece
Hungary
Norway
Poland
Portugal
Russian Federation
Slovakia
Spain
Switzerland
Turkey
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Relapsing Multiple sclerosis
Multiple sclerosis (G35)
MS
Interventions
Intervention
Description
Keyword
Informed Consent form , IMP administration , Visit assessment and schedule
Informed Consent form , IMP administration , Visit assessment and schedule
ICF, IMP
Primary Outcomes
Name
Time points
Measure
Annual Relapse Rate
96 weeks
number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
Key Secondary Outcomes
Name
Time points
Measure
Safety evaluation
96 weeks
Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs as well as proportion of patients discontinuing treatment due to insufficient effectiveness or safety
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
SUSAR(s) 01OCT2021 31MAR2022
03/06/2022
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