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出境医 / 临床实验 / Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Study Description
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 (RRMS), extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis (MS) Drug: Cladribine Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 675 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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)
Actual Study Start Date : August 15, 2019
Actual Primary Completion Date : February 27, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Cladribine Drug: 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.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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".

  2. Number of Participants in Each Category of Clinical Characteristics [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.

  3. Disease Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
  4. Relapse Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.

  5. Total Volume of Time Constant 2 (T2) Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Total Volume of T2 Lesions will be measured by Using Magnetic Resonance Imaging (MRI) Scans.

  6. Total Number of Time Constant 2 (T2) Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    T2 Lesions will be measured by Using MRI Scans.

  7. Number of Time Constant 1 (T1) Hypointense Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    T1 Hypointense Lesions will be measured by Using MRI Scans.

  8. Volume of Time Constant 1 (T1) Hypointense Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Total volume of T1 Hypointense Lesions will be measured by Using MRI Scans.

  9. Brain Volume [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Brain volume will be measured by Using MRI Scans.

  10. Ventricular Volume [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Ventricular Volume will be measured by Using MRI Scans.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations

Locations
Show Show 98 study locations
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE August 15, 2019
Actual Primary Completion Date February 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020) 		Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Percentage of Participants Using Wheelchair Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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".
  • Number of Participants in Each Category of Clinical Characteristics [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.
  • Disease Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
  • Relapse Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.
  • Total Volume of Time Constant 2 (T2) Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Total Volume of T2 Lesions will be measured by Using Magnetic Resonance Imaging (MRI) Scans.
  • Total Number of Time Constant 2 (T2) Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    T2 Lesions will be measured by Using MRI Scans.
  • Number of Time Constant 1 (T1) Hypointense Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    T1 Hypointense Lesions will be measured by Using MRI Scans.
  • Volume of Time Constant 1 (T1) Hypointense Lesions [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Total volume of T1 Hypointense Lesions will be measured by Using MRI Scans.
  • Brain Volume [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Brain volume will be measured by Using MRI Scans.
  • Ventricular Volume [ Time Frame: Within 6-14 weeks of signing the informed consent form ]
    Ventricular Volume will be measured by Using MRI Scans.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Percentage of Participants with 3-Month Sustained Expanded Disability Status Scale (EDSS) Score 6.0 or Higher [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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".
  • Number of Participants in Each Category of Clinical Characteristics [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.
  • Disease Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
  • Relapse Duration [ Time Frame: Within 2 weeks of signing the informed consent form ]
    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.
  • Total Volume of Time Constant 2 (T2) Lesions [ Time Frame: Within 6 weeks of signing the informed consent form ]
    Total Volume of T2 Lesions will be measured by Using Magnetic Resonance Imaging (MRI) Scans
  • Total Number of Time Constant 2 (T2) Lesions [ Time Frame: Within 6 weeks of signing the informed consent form ]
    T2 Lesions will be measured by Using MRI Scans.
  • Number of Time Constant 1 (T1) Hypointense Lesions [ Time Frame: Within 6 weeks of signing the informed consent form ]
    T1 Hypointense Lesions will be measured by Using MRI Scans.
  • Brain Volume [ Time Frame: Within 6 weeks of signing the informed consent form ]
    Brain volume will be measured by Using MRI Scans.
  • Ventricular Volume [ Time Frame: Within 6 weeks of signing the informed consent form ]
    Ventricular Volume will be measured by Using MRI Scans.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Official Title  ICMJE 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)
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 (RRMS), extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Multiple Sclerosis (MS)
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE Experimental: Cladribine
Intervention: Drug: Cladribine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2021) 		675
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		971
Estimated Study Completion Date  ICMJE September 30, 2021
Actual Primary Completion Date February 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   Finland,   France,   Georgia,   Germany,   Italy,   Korea, Republic of,   Lebanon,   Lithuania,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Switzerland,   Tunisia,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961204
Other Study ID Numbers  ICMJE MS700568_0026
2019-000069-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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