Cladribine effects on patient-reported outcomes and their clinical and biometric correlates in highly active relapsing multiple sclerosis at first switch: the observational, multicenter, prospective, phase IV CLADFIT-MS study.

Patient-reported outcomes (PROs) are essential for understanding the effects of MS and its treatments on patients' lives; they play an important role in multiple sclerosis (MS) research and practice. We present the protocol for an observational study to prospectively assess the effect of cladribine tablets on PROs and their correlation to disability and physical activity in adults with highly active relapsing MS switching from a first disease modifying drug (DMD) to cladribine tablets in routine clinical practice at study sites in Italy. The primary objective will be to evaluate changes from baseline in the impact of highly active MS on self-assessed physical functioning 52 weeks after the switch to cladribine tablets using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary objectives will include self-assessed psychological impact of highly active MS in daily life and general health after the switch to cladribine tablets as well as changes in cognitive function, anxiety, and depression symptoms. Additional PRO measures will include the Hospital Anxiety and Depression Scale (HADS), the EuroQoL 5-Dimension 5-Level (EQ-5D-5L), the Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), and the Patient-Reported Outcomes Measurement Information System (PROMIS). Wearable devices will acquire activity data (step counts, walking speed, time asleep, and energy expenditure). Additional clinical, radiological, and laboratory data will be collected when available during routine management. The findings will complement data from controlled trials by providing insight from daily clinical practice into the effect of cladribine tablets on the patient's experience and self-assessed impact of treatment on daily life.

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Copyright © 2024 Borriello, Chisari, Maimone, Mirabella, Paolicelli, Assogna, Caradonna and Patti.

Déclaration de conflit d'intérêts

DM received travel grants and honoraria for participating to Advisory Board and invited lectures from Alexion, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche, and Sanofi. MM has received honoraria for speaking, advisory board/consulting from Biogen, Novartis, Merck Serono, Roche, Almirall, Sanofi Genzyme, Janssen, Bristol-Myers Squibb, Viatris, Alexion. He is principal investigator in clinical trials for Biogen, Merck KGaA, Novartis, Roche, Sanofi Genzyme, CSL Behring, Ultragenix, Argenx. DP received speaker honoraria from Novartis, Sanofi-Genzyme, Biogen Idech, Merck, Roche, BMS, Almirall. FA and SC are employees of Merck Serono S.p.A., Italy, an affiliate of Merck KGaA. FP received personal fees for advisory and speaking activities by Alexion, Almirall, Biogen, Bristol Meyers & Squibb, Janssen, Merck, Novartis, Roche, Sanofi. He also received research grants by Alexion, Almirall, Biogen, Bristol Meyers & Squibb, Merck, Novartis, Roche, Sanofi, FISM, MUR, Italian Health Minister and Reload Onlus Association. The authors declare that this study received funding from Merck Serono S.p.A., Rome, Italy an affiliate of Merck (Cross Ref Funder ID: 10.13039/100009945). The funder had the following involvement in the study: study design, collection, data analysis and interpretation. Medical writing support was provided by EDITAMED S.r.l. and funded by Merck Serono S.p.A., Rome, Italy an affiliate of Merck. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.