Registro español de alteraciones hematoogicas durante el tratamiento con siponimod. (SILITOX Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45188
• EU PAS number:
  EUPAS45187
• Study ID:
  45188
• Official title and acronym:
  Registro español de alteraciones hematoogicas durante el tratamiento con siponimod. (SILITOX Study)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Siponimod blocks the action of cell receptors called 'sphingosine-1-phosphate receptors', which are involved in the movement of lymphocytes, thereby preventing the movement of lymphocytes from the lymph nodes to the brain and spinal cord. This redistribution of lymphocytes to secondary lymphoid organs produces a dose-dependent reduction in the number of peripheral lymphocytes. In the EXPAND study, grade 4 lymphopenia was observed in only 1% of patients. Newly marketed drugs require more information about aspects of efficacy or safety that may arise during their use in clinical practice, outside the controlled environment of the clinical trial. Siponimod is subject to additional monitoring, which will expedite the discovery of new information about its safety. In this context, a retrospective observational study is proposed to evaluate the real incidence of lymphopenia and other hematological alterations during, at least, the first three months of treatment with siponimod in real-life patients. A secondary objective will be to analyze the baseline characteristics that potentially predispose to lymphopenia, either by modifying the pharmacokinetic properties (age, sex, CY2C9 genotype, weight, dosage, or duration of treatment) or the pharmacodynamics (previous therapies received and concomitant therapies) of the drug. treatment with siponimod. Finally, it will be analyzed whether the appearance of lymphopenia and/or its intensity predispose to adverse events of an infectious nature.
• Study status:
  Finalised

Research institutions and networks

Institutions

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Clinical Pharmacology Department, Hospital La Paz, School of Medicine

Spain

Multiple centres: 15 centres are involved in the study. (Hospital Universitario San Carlos Madrid, Hospital Universitario Gomez Ulla Madrid, Hospital Universitario Ramon y Cajal Madrid, Hospital Vall Hebron Barcelona, Hospital del Mar/Hospital Germans Trias i Pujol Barcelona, Hospital Universitario de Bellvitge Barcelona, Hospital Universitario General de Valencia Valencia, Hospital Clínico Universitario de Valladolid Valladolid, Hospital Universitario Virgen del Rocio Sevilla, Hospital Universitario Virgen de la Victoria, Hospital Regional de Málaga Malaga)

Study timelines

Date when funding contract was signed

Planned: 10/06/2022

Actual: 13/02/2023

Study start date

Planned: 01/09/2022

Actual: 14/02/2023

Data analysis start date

Planned: 01/06/2022

Actual: 14/02/2023

Date of interim report, if expected

Planned: 01/02/2023

Actual: 14/02/2023

Date of final study report

Planned: 01/03/2023

Actual: 14/02/2023

Sources of funding

Other

More details on funding

The study is not funded

Study protocol

Initial protocol

PROTOCOLO ESTUDIO SIPONIMOD V1 1012021

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable