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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03961204




Registration number
NCT03961204
Ethics application status
Date submitted
22/05/2019
Date registered
23/05/2019
Date last updated
23/11/2020

Titles & IDs
Public title
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis (MS)
Scientific title
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials
Secondary ID [1] 0 0
2019-000069-19
Secondary ID [2] 0 0
MS700568_0026
Universal Trial Number (UTN)
Trial acronym
CLASSIC-MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cladribine

Experimental: Cladribine -


Treatment: Drugs: Cladribine
Participants will not receive any investigational medicinal product (IMP) in the study. Participants will be eligible who had participated in parent studies 25643 (NCT00213135), 27820 (NCT00641537) and 28821 (NCT00725985) and had received Cladribine tablets or placebo.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher - EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is 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.
Timepoint [1] 0 0
Within 2 weeks of signing the informed consent form
Secondary outcome [1] 0 0
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher - EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as "intermittent or unilateral constant assistance cane, crutch, brace required to walk about 100 meters with or without resting".
Timepoint [1] 0 0
Within 2 weeks of signing the informed consent form
Secondary outcome [2] 0 0
Number of Participants in Each Category of Clinical Characteristics - Clinical characteristics included gender, age/year of birth, race, ethnicity, education, employment status, disease modifying treatment and disease classification (relapsing remitting multiple sclerosis [RRMS] or Secondary Progressive Multiple Sclerosis [SPMS]). Number of participants in each category of clinical characteristics will be reported.
Timepoint [2] 0 0
Within 2 weeks of signing the informed consent form
Secondary outcome [3] 0 0
Disease Duration
Timepoint [3] 0 0
Within 2 weeks of signing the informed consent form
Secondary outcome [4] 0 0
Relapse Duration - A relapse will be defined as participant-reported symptoms and objectively observed signs typical of an acute inflammatory demyelinating event in the central nervous system (CNS), developing acutely or sub-acutely, with duration of at least 24 hours, in the absence of fever or infection.
Timepoint [4] 0 0
Within 2 weeks of signing the informed consent form
Secondary outcome [5] 0 0
Total Volume of Time Constant 2 (T2) Lesions - Total Volume of T2 Lesions will be measured by Using Magnetic Resonance Imaging (MRI) Scans.
Timepoint [5] 0 0
Within 6-14 weeks of signing the informed consent form
Secondary outcome [6] 0 0
Total Number of Time Constant 2 (T2) Lesions - T2 Lesions will be measured by Using MRI Scans.
Timepoint [6] 0 0
Within 6-14 weeks of signing the informed consent form
Secondary outcome [7] 0 0
Number of Time Constant 1 (T1) Hypointense Lesions - T1 Hypointense Lesions will be measured by Using MRI Scans.
Timepoint [7] 0 0
Within 6-14 weeks of signing the informed consent form
Secondary outcome [8] 0 0
Volume of Time Constant 1 (T1) Hypointense Lesions - Total volume of T1 Hypointense Lesions will be measured by Using MRI Scans.
Timepoint [8] 0 0
Within 6-14 weeks of signing the informed consent form
Secondary outcome [9] 0 0
Brain Volume - Brain volume will be measured by Using MRI Scans.
Timepoint [9] 0 0
Within 6-14 weeks of signing the informed consent form
Secondary outcome [10] 0 0
Ventricular Volume - Ventricular Volume will be measured by Using MRI Scans.
Timepoint [10] 0 0
Within 6-14 weeks of signing the informed consent form

Eligibility
Key inclusion criteria
- Participants with relapsing remitting multiple sclerosis (RRMS) randomised in
CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=)
1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo

- Participants with their first clinical demyelinating event randomised in ORACLE MS
clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo

- Participants who has sign informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form and this protocol
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who has 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 study participants at selected sites where MRI assessment will be conducted
following exclusion criteria will apply to MRI assessments only:

- Female study participants who are pregnant

- Participants who are taking Cladribine Tablets as part of another study at the time of
the start of this study

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - Camperdown
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Dakota
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United States of America
State/province [6] 0 0
Oklahoma
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United States of America
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Pennsylvania
Country [8] 0 0
Austria
State/province [8] 0 0
Linz
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Belgium
State/province [10] 0 0
Seraing
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Pleven
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Shumen
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Stara Zagora
Country [15] 0 0
Canada
State/province [15] 0 0
Gatineau
Country [16] 0 0
Canada
State/province [16] 0 0
Greenfield Park
Country [17] 0 0
Canada
State/province [17] 0 0
Ottawa
Country [18] 0 0
Croatia
State/province [18] 0 0
Split
Country [19] 0 0
Croatia
State/province [19] 0 0
VaraĹždin
Country [20] 0 0
Czechia
State/province [20] 0 0
Hradec Kralove
Country [21] 0 0
Czechia
State/province [21] 0 0
Olomouc
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava-Poruba
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 2
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 5
Country [25] 0 0
Czechia
State/province [25] 0 0
Teplice
Country [26] 0 0
Estonia
State/province [26] 0 0
Tallinn
Country [27] 0 0
Estonia
State/province [27] 0 0
Tartu
Country [28] 0 0
Finland
State/province [28] 0 0
Turku
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
State/province [30] 0 0
Nimes
Country [31] 0 0
France
State/province [31] 0 0
Rennes cedex 09
Country [32] 0 0
Georgia
State/province [32] 0 0
Tbilisi
Country [33] 0 0
Germany
State/province [33] 0 0
Duesseldorf
Country [34] 0 0
Germany
State/province [34] 0 0
Hanover
Country [35] 0 0
Germany
State/province [35] 0 0
Regensburg
Country [36] 0 0
Italy
State/province [36] 0 0
Bari
Country [37] 0 0
Italy
State/province [37] 0 0
Catania
Country [38] 0 0
Italy
State/province [38] 0 0
Chieti
Country [39] 0 0
Italy
State/province [39] 0 0
Genova
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Napoli
Country [42] 0 0
Italy
State/province [42] 0 0
Orbassano
Country [43] 0 0
Italy
State/province [43] 0 0
Pavia
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Goyang-si
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Lithuania
State/province [47] 0 0
Kaunas
Country [48] 0 0
Norway
State/province [48] 0 0
Haukeland
Country [49] 0 0
Norway
State/province [49] 0 0
Trondheim
Country [50] 0 0
Poland
State/province [50] 0 0
Gdansk
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Poland
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Lublin
Country [52] 0 0
Poland
State/province [52] 0 0
Poznan
Country [53] 0 0
Portugal
State/province [53] 0 0
Lisboa
Country [54] 0 0
Romania
State/province [54] 0 0
Bucaresti
Country [55] 0 0
Romania
State/province [55] 0 0
Targu Mures
Country [56] 0 0
Romania
State/province [56] 0 0
Timisoara
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Kemerovo
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Kursk
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Nizhny Novgorod
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Novosibirsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Rostov-on-don
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Saint-Petersburg
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Samara
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Russian Federation
State/province [65] 0 0
Saratov
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Russian Federation
State/province [66] 0 0
Smolensk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St. Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Tomsk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Tyumen
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Yaroslavl
Country [71] 0 0
Serbia
State/province [71] 0 0
Belgrade
Country [72] 0 0
Serbia
State/province [72] 0 0
Nis
Country [73] 0 0
Spain
State/province [73] 0 0
Córdoba
Country [74] 0 0
Spain
State/province [74] 0 0
Santa Cruz de Tenerife
Country [75] 0 0
Sweden
State/province [75] 0 0
Göteborg
Country [76] 0 0
Switzerland
State/province [76] 0 0
Lausanne
Country [77] 0 0
Tunisia
State/province [77] 0 0
Monastir
Country [78] 0 0
Tunisia
State/province [78] 0 0
Sfax
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kharkiv
Country [80] 0 0
Ukraine
State/province [80] 0 0
Vinnytsia
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Nottingham
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to explore the long-term outcomes, durability of effect, and
real world treatment patterns in participants previously participating in the Phase 3 oral
cladribine in first clinical demyelinating event(ORACLE MS) and Oral Cladribine in
participants with relapsing remitting multiple sclerosis, extension study
(CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643
(NCT00213135) and 27820 (NCT00641537) respectively.
Trial website
https://clinicaltrials.gov/show/NCT03961204
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US Medical Information
Address 0 0
Country 0 0
Phone 0 0
888-275-7376
Fax 0 0
Email 0 0
eMediUSA@emdserono.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03961204