Trial document




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  DRKS00015267

Trial Description

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Title

Long term, prospective, observational cohort study evaluating the safety profile in patients with highly active relapsing multiple sclerosis (RMS) newly started on oral cladribine

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Trial Acronym

CLARION

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is non-interventional, so participants will receive the treatment their treating physician assigns to them, independent of this study.

Both medications that are looked at in this study, are approved for use in patients with highly active Relapsing-Remitting Multiple Sclerosis.

The objective of this study is to further collect and evaluate data on (potential) side effects of oral cladribine over several years and to compare the safety profile of oral cladribine with that of fingolimod, in patients starting any of these two medicines.

The information from this study can be used to investigate if the medicines produce the desired therapeutic effect or not, and which factors might impact this.

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Brief Summary in Scientific Language

The research question is: What is the safety profile in terms of AESI (severe infections, herpes zoster infection, tuberculosis, progressive multifocal leukoencephalopathy (PML), other opportunistic infections, and malignancies) in patients with highly active MS newly initiating oral cladribine in the routine clinical practice, and how is this profile
comparatively to the safety profile of highly active MS patients newly initiating oral fingolimod?
Primary Objective:
• To further characterize and compare the risk, in terms of incidence of AESI (severe infections, herpes zoster infection, tuberculosis, PML, other opportunistic infections, and malignancies) in patients with highly active R(R)MS newly initiating oral cladribine or fingolimod.
Secondary Objectives:
• To assess the impact of the prior use of immunomodulatory / immunosuppressive agents on the incidence of AESI in patients with highly active R(R)MS newly initiating oral cladribine or fingolimod;
• To characterize the incidence and duration of severe lymphopenia in patients with highly active R(R)MS newly initiating oral cladribine;
• To describe further disease modifying therapy (DMT) prescribed when disease activity recurs in patients with highly active R(R)MS newly initiating oral cladribine;
Exploratory Objectives:
• To characterize treatment discontinuation and the reasons for discontinuation in patients with highly active R(R)MS newly initiating oral cladribine or fingolimod;
• To further characterize the relationship between severe lymphopenia and AESI in patients with highly active R(R)MS newly initiating oral cladribine.

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Organizational Data

  •   DRKS00015267
  •   2018/08/29
  •   2018/08/07
  •   no
  •   Approved
  •   EK 338092018, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  •   EUPAS24484  (European Union electronic Register of Post-Authorization Studies)
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Health Condition or Problem studied

  •   G35.9 -  [generalization G35: Multiple sclerosis]
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Interventions/Observational Groups

  •   Patients starting new with oral Cladribine

    - no investigations outside of clinical routine
  •   Patients starting new with Fingolimod

    - no investigations outside of clinical routine
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   IV
  •   No
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Primary Outcome

Number of AESIs (severe infections, herpes zoster infection, tuberculosis, PML, other opportunistic infections, and malignancies) in patients with highly active R(R)MS newly initiating oral cladribine or fingolimod

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Secondary Outcome

- Number of AESIs in patients with highly active R(R)MS newly initiating oral cladribine or
fingolimod by prior use of immunomodulatory/ immunosuppressive agents
In patients with highly active R(R)MS newly initiating oral cladribine:
- Number and duration of severe lymphopenia
- Number of patients by DMT after oral cladribine treatment in patients who experience a recurrence of disease activity

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Countries of Recruitment

  •   Germany
  •   Australia
  •   Belgium
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Italy
  •   Netherlands
  •   Norway
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2018/09/25
  •   8000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- Newly initiating oral cladribine or fingolimod according to local label for MS
- Written informed consent is obtained (in all countries for which the mixed model applies
(secondary data supplemented with primary data) and in some countries where only secondary data is used).

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Exclusion Criteria

- Received fingolimod prior to initiating oral cladribine;
- Received oral cladribine prior to initiating fingolimod.

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Addresses

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    • Merck KGaA
    • Frankfurter Str. 250
    • 64293  Darmstadt
    • Germany
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    • Merck KGaA
    • Ms.  MD, MPH, PhD  Meritxell  Sabidó Espin 
    • Frankfurter Str. 250
    • 64293  Darmstadt
    • Germany
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    • Merck KGaA
    • Ms.  MD, MPH, PhD  Meritxell  Sabidó 
    • Frankfurter Str. 250
    • 64293   Darmstadt
    • Germany
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Sources of Monetary or Material Support

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    • Merck KGaA
    • Frankfurter Str. 250
    • 64293  Darmstadt
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Beobachtungsplan
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