Trial document




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  DRKS00013587

Trial Description

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Title

CLEVER: CLadribine tablets - EValuation of therapy satisfaction

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Trial Acronym

CLEVER

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URL of the Trial

http://none

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Brief Summary in Lay Language

This observational study is conducted in patients who are suffering from multiple sclerosis and who are treated with Cladribine 10 mg. In the realm of the study the patients' treatment satisfaction is being evaluated.

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Brief Summary in Scientific Language

This is a prospective evaluation of treatment satisfaction in patients who suffer from multiple sclerosis and who are treated with Cladribine 10 mg (Mavenclad) as per registered label; the primary endpoint is patient's treatment satisfaction 6 months after treatment initiation.

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Organizational Data

  •   DRKS00013587
  •   2018/01/16
  •   [---]*
  •   no
  •   Approved
  •   EK 387102017, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G35 -  Multiple sclerosis
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Interventions/Observational Groups

  •   Patients who suffer of multiple sclerosis and are already being treated with Cladribin will be asked whether they would like to participate in this observational trial. If they confirm their consent in writing, the following questionnaires will be handed out to them for completion:
    Treatment Satisfaction Questionnaire for Medication (TSQM), Service questionnaire and Usage questionnaire for patients.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

The primary endpoint is overall treatment satisfaction with Cladribine tablets as assessed by the Global Satisfaction subscale score of the questionnaire TSQM-14 (Version 1.4) in week 24.

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Secondary Outcome

Secondary Objective are:
To assess treatment satisfaction with Cladribine
tablets with special focus on patient perceived
effectiveness, tolerability, convenience;

To describe patients’ characteristics and profile prior to Cladribine treatment (demographics, prior MS treatments, disease severity);

To evaluate predictors of treatment satisfaction; and Participation in Patient Support Program (PSP).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/16
  •   700
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

· Patients (male or female) aged 18 years and over
· All patients eligible to receive Cladribine tablets as per registered label
· Patients using Cladribine tablets for the first time.
- Inclusion to the NIS can occur at treatment initiation or within 24 weeks after treatment initiation
· Signed informed consent

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Exclusion Criteria

· Existing pregnancy or lactation
· Contraindications to use of Cladribine tablets
according to the Summary of Product Characteristics

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Addresses

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    • Merck Serono GmbH, Germany
    • Alsfelder Str. 17
    • 64289  Darmstadt
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Merck Serono GmbH
    • Ms.  PhD  Anita  Posevitz-Fejfár 
    • Alsfelder Str. 17
    • 64289   Darmstadt
    • Germany
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    • Merck Serono GmbH
    • Ms.  PhD  Anita  Posevitz-Fejfár 
    • Alsfelder Str. 17
    • 64289  Darmstadt
    • Germany
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Sources of Monetary or Material Support

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    • Merck Serono GmbH, Germany
    • Alsfelder Str. 17
    • 64289  Darmstadt
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.