Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03961204
Ethics application status
Date submitted
22/05/2019
Date registered
23/05/2019

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

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Data Collection

Other: Cohort A - The participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.


Other interventions: Data Collection
No study treatment was administered as part of this study
Intervention code [1] 0 0
Other interventions
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
Timepoint [1] 0 0
3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
Secondary outcome [1] 0 0
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
Timepoint [1] 0 0
At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
Secondary outcome [2] 0 0
Clinical and Demographic Characteristic: Age, Disease Duration
Timepoint [2] 0 0
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [3] 0 0
Number of Participants in Each Category of Clinical and Demographic Characteristics
Timepoint [3] 0 0
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [4] 0 0
Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
Timepoint [4] 0 0
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [5] 0 0
Clinical Characteristic: Number of Relapses
Timepoint [5] 0 0
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [6] 0 0
Number of Total T1-weighted (T1-W) Lesions
Timepoint [6] 0 0
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [7] 0 0
Number of Total T2-weighted (T2-W) Lesions
Timepoint [7] 0 0
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [8] 0 0
T1-weighted (T1-W) Lesion Volume
Timepoint [8] 0 0
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [9] 0 0
T2-weighted (T2-W) Lesion Volume
Timepoint [9] 0 0
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Secondary outcome [10] 0 0
Total Brain Volume
Timepoint [10] 0 0
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

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
Sex
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
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2021
Sample size
Target
Accrual to date
Final
662
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
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
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
Burnaby
Country [16] 0 0
Canada
State/province [16] 0 0
Gatineau
Country [17] 0 0
Canada
State/province [17] 0 0
Greenfield Park
Country [18] 0 0
Canada
State/province [18] 0 0
Ottawa
Country [19] 0 0
Croatia
State/province [19] 0 0
Split
Country [20] 0 0
Croatia
State/province [20] 0 0
Varaždin
Country [21] 0 0
Czechia
State/province [21] 0 0
Hradec Kralove
Country [22] 0 0
Czechia
State/province [22] 0 0
Olomouc
Country [23] 0 0
Czechia
State/province [23] 0 0
Ostrava-Poruba
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 2
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 5
Country [26] 0 0
Czechia
State/province [26] 0 0
Teplice
Country [27] 0 0
Estonia
State/province [27] 0 0
Tallinn
Country [28] 0 0
Estonia
State/province [28] 0 0
Tartu
Country [29] 0 0
Finland
State/province [29] 0 0
Turku
Country [30] 0 0
France
State/province [30] 0 0
Lille
Country [31] 0 0
France
State/province [31] 0 0
Nimes
Country [32] 0 0
France
State/province [32] 0 0
Rennes cedex 09
Country [33] 0 0
Georgia
State/province [33] 0 0
Tbilisi
Country [34] 0 0
Germany
State/province [34] 0 0
Duesseldorf
Country [35] 0 0
Germany
State/province [35] 0 0
Hanover
Country [36] 0 0
Germany
State/province [36] 0 0
Regensburg
Country [37] 0 0
Germany
State/province [37] 0 0
Rostock
Country [38] 0 0
Italy
State/province [38] 0 0
Bari
Country [39] 0 0
Italy
State/province [39] 0 0
Catania
Country [40] 0 0
Italy
State/province [40] 0 0
Chieti
Country [41] 0 0
Italy
State/province [41] 0 0
Gallarate
Country [42] 0 0
Italy
State/province [42] 0 0
Genova
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Napoli
Country [45] 0 0
Italy
State/province [45] 0 0
Orbassano
Country [46] 0 0
Italy
State/province [46] 0 0
Pavia
Country [47] 0 0
Italy
State/province [47] 0 0
Roma
Country [48] 0 0
Italy
State/province [48] 0 0
Rome
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Goyang-si
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Lebanon
State/province [51] 0 0
Beirut
Country [52] 0 0
Lithuania
State/province [52] 0 0
Kaunas
Country [53] 0 0
Norway
State/province [53] 0 0
Haukeland
Country [54] 0 0
Norway
State/province [54] 0 0
Trondheim
Country [55] 0 0
Poland
State/province [55] 0 0
Gdansk
Country [56] 0 0
Poland
State/province [56] 0 0
Lublin
Country [57] 0 0
Poland
State/province [57] 0 0
Poznan
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Portugal
State/province [59] 0 0
Lisboa
Country [60] 0 0
Romania
State/province [60] 0 0
Bucaresti
Country [61] 0 0
Romania
State/province [61] 0 0
Targu Mures
Country [62] 0 0
Romania
State/province [62] 0 0
Timisoara
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Kemerovo
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Kursk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Nizhny Novgorod
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Novosibirsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Rostov-on-don
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Saint-Petersburg
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Samara
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saratov
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Smolensk
Country [73] 0 0
Russian Federation
State/province [73] 0 0
St. Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Tomsk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Tyumen
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Yaroslavl
Country [77] 0 0
Serbia
State/province [77] 0 0
Belgrade
Country [78] 0 0
Serbia
State/province [78] 0 0
Nis
Country [79] 0 0
Spain
State/province [79] 0 0
Córdoba
Country [80] 0 0
Spain
State/province [80] 0 0
Santa Cruz de Tenerife
Country [81] 0 0
Sweden
State/province [81] 0 0
Göteborg
Country [82] 0 0
Switzerland
State/province [82] 0 0
Lausanne
Country [83] 0 0
Tunisia
State/province [83] 0 0
Monastir
Country [84] 0 0
Tunisia
State/province [84] 0 0
Sfax
Country [85] 0 0
Tunisia
State/province [85] 0 0
Tunis
Country [86] 0 0
Ukraine
State/province [86] 0 0
Kharkiv
Country [87] 0 0
Ukraine
State/province [87] 0 0
Vinnytsia
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Nottingham
Country [89] 0 0
United Kingdom
State/province [89] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available to whom?
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://bit.ly/IPD21


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Giovannoni G, Boyko A, Correale J, Edan G, Freedma... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03961204