Long term monitoring of multiple sclerosis patients on cladribine treatment
Type of Study/Intervention
Form of MS
Relapsing remitting MS
Multiple sclerosis (MS) is the most common non-traumatic neurological disorder that affects young adults. Cladribine tablets (Mavenclad®) is a new oral therapy for MS. The current dosing for cladribine tablets is 2 courses given one year apart. This has been shown to be effective in reducing relapses in 75% of patients for up to 4 years (based on annualised relapse rate). However, re-initiation of treatment after year 4 has not been studied. This will be a multicenter, 6-year, phase IV, low interventional trial. Subjects meeting the eligibility criteria will receive an initial treatment course in year 1 and a continuing treatment course in year 2. After 3 years, patients will have the option for re-initiation of treatment, if clinically indicated or the option to switch to another disease modifying therapy (DMT). This study is testing the hypothesis that patients who receive an additional course of cladribine tablets will experience less disease activity than those who chose to change DMT.
During the study we will evaluate blood-based molecules called biomarkers, brain scans and brain function tests. At the end of the study, we will use the results of these tests to determine if there are ways to decide if re-initiation of treatment after the initial 2-year course is appropriate. This may be one test or a combination of several tests. In addition, we determine if these biomarkers can be used at onset of disease to determine if patients will respond to cladribine therapy before they start.
• 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
• 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.
Anticipated start date
Jeannette Lechner-Scott: [email protected]
T: 02 4921 3540
NSW, QLD, SA, TAS, VIC, WA
Full details of the trial can be found on the ANZCTR clinical trials database: http://www.ANZCTR.org.au/ACTRN12619000257167.aspx