CAMELOT-MS Cladribine tablets in Highly-active Relapsing MS

• Research type

  Research Study

• Full title

  Cladribine tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice

• IRAS ID

  295925

• Contact name

  Wallace Brownlee

• Contact email

  wallace.brownlee1@nhs.net

• Sponsor organisation

  Merck Serono Ltd

• Duration of Study in the UK

  1 years, 11 months, 26 days

• Research summary

  Research Summary: The purpose of this observational research study is to investigate the effectiveness of cladribine tablets in a UK real-world setting in patients with highly-active relapsing Multiple Sclerosis (MS). Real-world insights, data and experience are becoming increasingly important to inform clinical decisions of treatment choice in MS.
  The study will collect information from patient chart reviews to allow investigation of the medium to long-term treatment outcomes and patterns of cladribine tablets in standard clinical practice. This study will take place in patients' usual clinics rather than trial units where typically there are additional interventions applied.
  In the UK, the first patients to be treated with cladribine tablets were initiated on the treatment soon after the EU marketing authorization in August 2017. The UK currently has a large patient population that has been treated with cladribine tablets including patients already entering the fourth year after treatment initiation. The recruitment of patients who have already initiated treatment maximizes the follow-up time and minimizes the time needed to collect data.
  The study will run for approximately 2 years at UK hospitals. Patients will consent to their data being extracted from their medical records at two timepoints. The first timepoint is at enrolment and the second timepoint is 12 months after enrolment. The data extracted will span the 12 months prior to a patient starting on cladribine tablets to 12 months after enrolment. This is a chart review study only and there are no study visits or procedures that the patient will need to attend or complete for this study besides a consent visit. The consent visit may be conducted face to face or remotely.

  Summary of results: the study doctors reported a decrease in the number of relapses in the participants over 5 years after the first treatment with cladribine tablets. Specifically, one year after the first
  treatment, the study doctors observed that there were 83%
  fewer relapses compared to before starting the treatment with
  cladribine tablets. This reduction in relapses continued and by
  the fifth year, the participants experienced 89% fewer relapses.
  There were 116 participants in this study. 35 (30.2%) participants
  had unwanted effects that the study doctors reported as at least
  possibly related to the study treatment. The most common unwanted
  effect that the study doctors thought might be related to the study
  treatment was a temporary decrease in white blood cells (called
  lymphocytes) in the blood. This reduction, known as lymphopenia, is
  connected to how cladribine tablets function in the body. Lymphopenia is common in people taking cladribine tablets and it is expected that most people recover to either normal white blood cell counts or mild lymphopenia within 9 months of taking the last tablet

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  21/WM/0137

• Date of REC Opinion

  7 Jun 2021

• REC opinion

  Further Information Favourable Opinion