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Trial details
Trial details
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis
Current status:
Approved
|
Date registered:
18/03/2020
|
Date last updated:
16/03/2020
Trial version(s)
History: 26/03/2019
Current: 26/03/2019
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2020030215
Protocol number
MS700568_0026
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
25/07/2019
Primary sponsor
Merck KGaA
Primary sponsor: Country of origin
Germany
Public title
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis
Acronym
Scientific title
An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials
Acronym
Brief summary of the study: English
The purpose of this study is to explore the long-term outcomes, durability of effect, and real-world treatment patterns in patients previously participating in the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials (i.e. parent studies). The results from this study may be of benefit to patients with multiple sclerosis (MS) and clinicians by helping to inform future treatment approaches and treatment decision-making.
Brief summary of the study: Arabic
عند مرضى مصابين بتصلّب المتعدد Cladribine تقييم النتائج طويلة الأمد و مدّة تأثير العلاج بأقراص
Health conditions/problem studied: Specify
Multiple Sclerosis
Interventions: Specify
No Intervention, except: *Optional blood sample: Patients willing to consent to provide an optional blood sample and who are seen at a site with available capabilities to store and ship samples, will have a blood draw taken at Study Visit 1 for pharmacogenetics testing.
Key inclusion and exclusion criteria: Inclusion criteria
1. Patients with MS randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received ≥ 1 course of IMP (Cladribine Tablets or placebo). or Patients with their FCDE randomised in ORACLE MS clinical trial who have received≥ 1 course of IMP (Cladribine Tablets or placebo). 2. Informed Consent
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
65
Key inclusion and exclusion criteria: Exclusion criteria
1. Medical Conditions: Any condition, including any uncontrolled disease state other than MS, that in the Investigator’s opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation. For the MRI sub-study: 1. Female Participants Who are pregnant 2. Patient taking Cladribine Tablets as part of another study at the time of the start of this study
Type of Study
Type
Observational
Study model
Cohort
Study model: Explain model
NA
Time perspective
Other
Time perspective: Specify perspective
Ambispective
Time perspective: Explain time perspective
Ambispective: Retrospective and Prospective
Target follow-up duration
6
Target follow-up duration: Unit
Weeks
Number of groups/cohorts
4
Biospecimen retention
Samples with DNA**
Biospecimen description
8ml blood sample will be collected for DNA analysis from consenting participants
Target sample size
8
Actual enrollment target size
Date of first enrollment: Type
Actual
Date of first enrollment: Date
15/08/2019
Date of study closure: Type
Actual
Date of study closure: Date
28/02/2021
Recruitment status
Recruiting
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
NO Individual Patient Data Sharing
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
European Clinical Trials Database
EudraCT number: 2019-000069-19
Sources of Monetary or Material Support
Name
Merck KGaA Germany
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Dr. Bassem
Yamout
Hamra, Cairo Street
Lebanon
+9613221222
-
American University of Beirut Medical Center
Scientific
Kristin
Gabriel
EMD Serono, Inc. One Technology Place, Rockland MA 02370
United States of America
+1 781 427 1502
Kristin.Gabriel@emdserono.com
EMD Serono, Inc.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Bellevue Medical Center
Dr. Souheil Gbeily
Neurology
Approved
American University of Beirut Medical Center
Dr. Bassem Yamout
Neurology
Not approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Bellevue Medical Center
10/09/2019
Prof. Souheil Jbeily
souheil.gebeily@gmail.com
9611682666
Countries of Recruitment
Name
Australia
Austria
Belgium
Bulgaria
Canada
Croatia
Czech Republic
Estonia
Finland
France
Georgia
Germany
Greece
Italy
Republic of Korea
Latvia
Lithuania
Morocco
Norway
Poland
Portugal
Romania
Russian Federation
Republic of Serbia
Spain
Sweden
Switzerland
Tunisia
Ukraine
United Kingdom
United States of America
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Multiple Sclerosis
Multiple sclerosis (G35)
MS, Multiple Sclerosis
Interventions
Intervention
Description
Keyword
Optional Blood Sampling
Purpose: Pharmaco-genetics Testing
blood sampling
Primary Outcomes
Name
Time points
Measure
To evaluate long-term mobility after treatment with an investigational medicinal product (IMP; Cladribine Tablets or placebo) as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials.
Proportion of study participants using a wheelchair (defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day) the majority of the time in the 3 months prior to Study Visit 1 for the CLARITY/CLARITY-EXT and ORACLE MS populations,
• Expanded Disability Status Scale (EDSS) score of 7.0 or higher (if available), or • Alternative clinical description data in medical records.
Key Secondary Outcomes
Name
Time points
Measure
To assess the long-term disability status after treatment with IMP as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials for the CLARITY/CLARITY-EXT and ORACLE MS populations.
Proportion of study participants with 3-month sustained (i.e. ambulatory disability consistent with EDSS on at least 2 clinic visits no less than 3 months apart)
EDSS of 6.0 or higher in the last year prior to enrollment or corresponding clinical description in medical records
To evaluate differences in clinical characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
Clinical characteristics at Study Visit 1 of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last doseb of IMP and who did not receive disease modifying treatment until Year 4 or later following their last doseb of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last doseb of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
-
To evaluate differences in magnetic resonance imaging (MRI) characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
MRI characteristics at Study Visit 2 of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last doseb of IMP and who did not receive disease modifying treatment until Year 4 or later following their last doseb of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last doseb of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
-
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
Download as PDF
Save a PDF copy of the summary of the trial