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Clinical Trials/ACTRN12619000257167
ACTRN12619000257167Active, not recruitingPhase 3

Cladribine: a multicenter, LOng-term efficacy and Biomarker Australian Study in patients with relapsing-remitting multiple sclerosis.

John Hunter Hospital of Hunter New England Local Health District0 sites150 target enrollmentStarted: February 20, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Sponsor
Enrollment
150
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 70 Years (—)
Sex
All

Inclusion Criteria

  • •To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
  • •Subjects must be eligible for and already intending to commence cladribine tablets in accordance with the Australian PI.
  • •Subjects must have the ability to understand the purpose and risks of the study, as outlined in the Patient Informed Consent Form (PICF) and provide signed and informed consent and authorization to use protected health information (PHI) in accordance with nation and local privacy regulations.
  • •Subjects must meet the McDonald criteria (2017) for the diagnosis of RRMS.
  • •Male or female subjects aged 18-70 years old
  • •Be able to provide details for or consent to providing access to a stored minimum dataset (ie demographics, date of diagnosis, relapse information, baseline EDSS)
  • •Be able and willing to comply with all study procedures, including MRI scanning as per protocol.
  • •Must agree to use contraception from baseline until 6 months after the last dose of cladribine tablets, unless their partners are infertile or surgically sterile.
  • •Subjects must be aware of all precautions listed in the PI for Mavenclad® and any subsequent DMD treatment received within this clinical study must be adhered to

Exclusion Criteria

  • •To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
  • •Subjects must not have a concurrent diagnosis of a neurological, psychiatric or other disease which, in the opinion of the investigator, could impair capacity to provide informed consent, interfere with study assessments or impair the participant’s ability to comply with the study protocol.
  • •Any contra-indication to MRI scanning including:
  • •Cardiac pacemaker
  • •Cardiac defibrillator
  • •Metal fragments in the eye
  • •Any other non-MRI compatible medical device / implant or medical condition
  • •Severe claustrophobia
  • •Subjects who have any contraindication listed on the Australian PI or who have any of the listed precautions listed on the Australian PI.
  • •Patients who have highly active MS (defined as one relapse in the previous year and at least 1 T1Gd+ lesion or 9 or more T2 lesions, while on therapy with other DMTs. Two or more relapses in the previous year, whether on DMT treatment or not), who also have an EDSS of less than or equal to 5.0) and have not had prior exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.
  • •The Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the trial.

Investigators

Sponsor
John Hunter Hospital of Hunter New England Local Health District

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