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Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

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ClinicalTrials.gov Identifier: NCT04783935
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Description
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Brief Summary:
The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Mavenclad® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cladribine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mavenclad® Drug: Mavenclad®
No intervention will be administered as a part of this study. Participants who had received Mavenclad® up to 2 years (Year 1 and 2) in the parent study MS700568_0022 (NCT03364036) will be enrolled into this extension study and will be assessed up to 2 years follow-up (Year 3 and 4).
Other Name: Cladribine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 [ Time Frame: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study ]
    NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.


Secondary Outcome Measures :
  1. Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and 4 [ Time Frame: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study ]
    NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.

  2. Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Onset of Action of Mavenclad® Treatment During the Parent Study until the End of Year 3 and 4 [ Time Frame: After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4 ]
    NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.

  3. Percentage of Participants Remaining Three Parameter No Evidence of Disease Activity (NEDA-3) During Year 3 or 4 among those with NEDA-3 During Year 1 or 2 [ Time Frame: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study ]
    NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.

  4. Time to First Disease Activity at Year 3 and 4 [ Time Frame: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study ]
  5. Time to First Disease Activity During up to 4 Years [ Time Frame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) ]
  6. Time to First New or Enlarging T2 Lesion [ Time Frame: From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) ]
  7. Time to First New T1 Gadolinium Enhancing (Gd+) Lesion [ Time Frame: From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) ]
  8. Time to First Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) [ Time Frame: From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) ]
  9. Time to First Qualifying Relapse [ Time Frame: From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) ]
  10. Time to Second Qualifying Relapse [ Time Frame: From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) ]
  11. Time to Treatment Start with Other Disease Modifying Drugs (DMDs) [ Time Frame: From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) ]
  12. Time from Extension Study Baseline to First New or Enlarging T2 Lesion [ Time Frame: Time from Baseline (extension study), up to 2 years ]
  13. Time from Extension Study Baseline to First New T1 Gadolinium Enhancing (Gd+) Lesion [ Time Frame: Time from Baseline (extension study), up to 2 years ]
  14. Time from Extension Study Baseline to First Confirmed Disability Progression (CDP), as measured by Expanded Disability Status Scale (EDSS) [ Time Frame: Time from Baseline (extension study), up to 2 years ]
  15. Time from Extension Study Baseline to First Qualifying Relapse [ Time Frame: Time from Baseline (extension study), up to 2 years ]
  16. Time from Extension Study Baseline to Second Qualifying Relapse [ Time Frame: Time from Baseline (extension study), up to 2 years ]
  17. Time from Extension Study Baseline to Treatment Start with Other Disease Modifying Drugs (DMDs) [ Time Frame: Time from Baseline (extension study), up to 2 years ]
  18. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants of the MAGNIFY Multiple Sclerosis (MS) trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on Magnetic resonance imaging (MRI) is available/acquired from at least parent study Month 18 or Month 24 visit and Expanded Disability Status Scale (EDSS) and relapse from parent study Month 24 visit
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Participation in other studies/trials
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783935


Contacts
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Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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Sponsors and Collaborators
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
More Information
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Additional Information:

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Responsible Party: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT04783935    
Other Study ID Numbers: MS700568_0157
2020-003995-42 ( EudraCT Number )
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
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, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany:
Multiple Sclerosis
Mavenclad ®
Cladribine
Relapsing Multiple Sclerosis
Immune cell kinetics
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs