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THUR 172 Phase iv study of cladribine tablets and quality of life: clarify-ms
  1. S Schippling1,
  2. D Langdon2,
  3. A Solari3,
  4. B Brochet4,5,
  5. R Hupperts6,
  6. F Piehl7,
  7. J Lechner-Scott8,
  8. X Montalban9,10,
  9. B Keller11,
  10. N Alexandri11
  1. 1University Hospital Zürich, Rämistrasse, Zürich, Switzerland
  2. 2Royal Holloway, University of London, Egham, Surrey, UK
  3. 3Foundation IRCCS Neurological Institute C. Besta, Milano, Italy
  4. 4Université Bordeaux-Segalen, France
  5. 5Centre Hospitalier-Universitaire of Bordeaux, France
  6. 6Orbis Medisch Centrum, Sittard, The Netherlands
  7. 7Karolinska Institutet, Stockholm, Sweden
  8. 8University of Newcastle, University Drive, Callaghan, Australia
  9. 9Division of Neurology, St Michael’s Hospital, University of Toronto, Toronto, ON, Canada
  10. 10Department of Neurology-Neuroimmunology, Multiple Sclerosis of Catalonia (Cemcat), Vall d’Hebron University Hospital, Vall d’Hebron, Barcelona, Spain
  11. 11Merck KGaA, Darmstadt, Germany


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Background Relapsing multiple sclerosis (RMS) negatively affects health-related quality of life (HRQoL).

Objective An open-label, single-arm, exploratory Phase IV study in centres in Europe and Australia will assess HRQoL in RMS patients receiving CT 3.5 mg/kg (CT3.5).

Methods Eligible patients will receive CT 3.5 (cumulative) over 2 years. HRQoL (Multiple Sclerosis Quality of Life-54 [MSQoL-54]) and other patient-reported outcomes (Fatigue Severity Scale; Hospital Anxiety and Depression Scale; Treatment Satisfaction Questionnaire for Medication v1.4) will be assessed at baseline, and at 6, 12, 24 months.

Other outcomes include AEs, MRI measures (T1 Gd+ lesions, T2 lesions, brain atrophy), number of relapses, and disability/functioning measures (EDSS; 9-Hole Peg Test; Timed 25-Foot Walk and Brief International Cognitive Assessment for Multiple Sclerosis). The sample size estimation is based on the power to detect a mean difference of 5 points in MSQoL-54 composite score at 24 months vs baseline.

Results The study aims to recruit 356 adults with RMS by 2019. Final data are anticipated in 2022.

Conclusions This study will explore the effects of CT on HRQoL outcomes, and describe the effects of CT on treatment satisfaction and disability/functioning.

Disclosure statement The trial is sponsored by Merck KGaA, Darmstadt, Germany.

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