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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    971
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 25 November 2020
Investigator
US Medical Information
Primary Contact
University of Sydney (7.3 mi away) Contact
+81 other location
cladribine
relapsing multiple sclerosis

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 early multiple sclerosis (ORACLE MS) and Oral Cladribine in participants with relapsing remitting multiple sclerosis, extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.

Details
Treatment cladribine
Clinical Study IdentifierNCT03961204
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on25 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Radiologically Isolated Syndrome or Multiple Sclerosis or Dermatite Atopique modérée ou grave?
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
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
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