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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  • 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

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Maryland, Baltimore - Maryland Center for MS
Baltimore, Maryland 21201
Contact:
hrus@som.umaryland.edu

More Details

NCT ID
NCT03961204
Status
Recruiting
Sponsor
EMD Serono Research & Development Institute, Inc.

Study Contact

US Medical Information
888-275-7376
service@emdgroup.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.