MSFrontier

FNO-RS2-OCREPRIPRO

The use of therapeutic monitoring of ocrelizumab serum concentrations for personalized pharmacotherapy of relapsing-remitting and primary progressive multiple sclerosis
RecruitingPhase 4Relapsing and progressive2024-514549-12-00

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • To determine serum concentrations of neurofilament light chains (ng/L)

    Blood or spinal fluid markersHow the body handles the medicine

  • To determine serum concentrations of glial fibrillary acidic protein (ng/L)

    How the body handles the medicine

  • To determine the presence of antibodies against OCR (mg/L)

  • To determine the number of CD19+ cells (or other cells of the immune system that are associated with MS)

    Immune response

  • To determine the quality of life measured with the MSQOL-54 questionnaire (point value score)

    Quality of life (reported by participants)

  • To assess clinical status using the 25FWT, 9HPT and SDMT tests (point value score)

    Disability progressionThinking and memory

  • To assess the results of brain magnetic resonance examination (number of new or recently enlarged T2 lesions or T1 Gd+ lesions, average percentage change in brain volume)

    MRI lesionsBrain volume loss

  • To determine disability progression (assessed as change on the EDSS scale)

    Disability progression

  • To determine the course of MS (assessed as NEDA-3 concept)

  • To determine occurrence of relapses since the previous check-up (for patients with relapsing remitting MS)

    Relapses

Other measures (4)

  • To determine serum concentrations of OCR in patients with RR and/or PP RS – observational goal

    How the body handles the medicine

  • To determine whether the dose of OCR or the serum concentration of OCR better correlates with the development of paraclinical and clinical parameters and with the prognosis of patients with RR and/or PP MS - observational goal

    How the body handles the medicine

  • To analyze the correlation of possible adverse effects of OCR with its measured serum concentration; evaluated variables: OCR adverse effects (infectious and other), blood count, serum creatinine concentration (µmol/L), eGFR (ml/s), serum concentration of IgG (g/L) and IgM (g/L) – safety target

    How the body handles the medicineSafety

  • On the basis of the obtained data, possibly introduce TDM OCR into routine clinical practice in patients with RR and/or PP MS and thus expand the multidisciplinary approach to patients with this diagnosis – implementation goal

Who could take part

Relapsing and progressive · 18 and over

Inclusion: - Patients diagnosed with RR and/or PP RS with already established or newly started OCR treatment - Men and women older than 18 years - Signing the Informed Consent to participate in the study - Female patients of childbearing age who can become pregnant must have a negative result of serum human chorionic gonadotropin (hCG) at the initial visit and use a highly reliable method of contraception with a home control urine pregnancy test every month for the entire duration of the study Exclusion: - Hypersensitivity to the medicinal substance or to any excipient - Current active infection - Patients in a severe immunocompromised state - Known active malignant disease - Pregnancy or breastfeeding

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

To determine whether and how serum OCR concentrations correlate with selected paraclinical and clinical indicators in patients with relapsing-remitting and/or primary progressive MS

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History

    1. Started

      Jun 2025

    2. Finished

      Aug 2026

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