ong term monitoring of multiple sclerosis patients on cladribine treatment

Phase 3

Active, not recruiting

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12619000257167
• Lead Sponsor: John Hunter Hospital of Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the treatment response status of patients taking cladribine tablets over 6-years according to NEDA3 (No Evidence of Disease Activity) criteria.[ at 72 months (6 years) post-baseline.]

Secondary Outcome Measures

Name	Time	Method
Treatment response status of patients taking cladribine tablets over 6-years according to NEDA4 (No Evidence of Disease Activity) criteria (which includes brain volume loss).[ 72 months post-baseline];Composite secondary outcome: Biomarker analysis using whole blood flow cytometry assays to assess changes in the proportion of lymphocytes (T-cells, B-cells and natural killer (NK) cells) and the proportion of B memory cells.<br>[ 3, 7, 12, 18, 24, 36, 48, 60, and 72 months post=baseline];Biomarker analysis using digital ELISA assays to assess changes in the concentration of serum neurofilament light chain.[ 7, 12, 18, 24, 36, and 72 months post-baseline];Exploratory outcome: Biomarker analysis using whole blood DNA methylation assays to assess genome-wide changes in DNA methylation profile[ 7, 24 and 72 months post-baseline]