OCRELIZUMAB for Multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Patients diagnosed with RR and/or PP RS with already established or newly started OCR treatment\n- Men and women older than 18 years\n- Signing the Informed Consent to participate in the study\n- 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 criteria

• {"criterion_text":"- Hypersensitivity to the medicinal substance or to any excipient\n- Current active infection\n- Patients in a severe immunocompromised state\n- Known active malignant disease\n- Pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- To determine serum concentrations of neurofilament light chains (ng/L)","definition_or_measurement_approach":"Measurement of serum neurofilament light chain concentrations expressed in ng/L"}
• {"endpoint_text":"- To determine serum concentrations of glial fibrillary acidic protein (ng/L)","definition_or_measurement_approach":"Measurement of serum glial fibrillary acidic protein concentrations expressed in ng/L"}
• {"endpoint_text":"- To determine the presence of antibodies against OCR (mg/L)","definition_or_measurement_approach":"Measurement of anti-ocrelizumab antibodies in serum (concentration in mg/L)"}
• {"endpoint_text":"- To determine the number of CD19+ cells (or other cells of the immune system that are associated with MS)","definition_or_measurement_approach":"Quantification of CD19+ cell counts (or other relevant immune cell counts) in peripheral blood"}
• {"endpoint_text":"- To determine the quality of life measured with the MSQOL-54 questionnaire (point value score)","definition_or_measurement_approach":"Patient-reported quality of life assessed using the MSQOL-54 questionnaire (point value score)"}
• {"endpoint_text":"- To assess clinical status using the 25FWT, 9HPT and SDMT tests (point value score)","definition_or_measurement_approach":"Clinical performance assessed with the 25-Foot Walk Test (25FWT), 9-Hole Peg Test (9HPT) and Symbol Digit Modalities Test (SDMT); results recorded as point/value scores"}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Brain MRI evaluation: count of new or recently enlarged T2 lesions and T1 Gd+ lesions; measurement of average percentage change in brain volume"}
• {"endpoint_text":"- To determine disability progression (assessed as change on the EDSS scale)","definition_or_measurement_approach":"Assessment of disability progression as change in Expanded Disability Status Scale (EDSS) score"}
• {"endpoint_text":"- To determine the course of MS (assessed as NEDA-3 concept)","definition_or_measurement_approach":"Assessment of disease course using the NEDA-3 composite concept (no evidence of disease activity across defined components)"}
• {"endpoint_text":"- To determine occurrence of relapses since the previous check-up (for patients with relapsing remitting MS)","definition_or_measurement_approach":"Count and documentation of clinical relapses occurring since the prior visit for patients with relapsing-remitting MS"}

Secondary endpoints

• {"endpoint_text":"- To determine serum concentrations of OCR in patients with RR and/or PP RS – observational goal","definition_or_measurement_approach":"Measurement of serum ocrelizumab concentrations in study participants (observational)"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Analytical correlation between ocrelizumab dose or serum concentration and paraclinical/clinical parameter changes and patient prognosis (observational analysis)"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Correlation analysis between measured ocrelizumab serum concentrations and adverse effects; safety variables include infection events, blood count, serum creatinine (µmol/L), eGFR (ml/s), IgG (g/L) and IgM (g/L)"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Implementation objective assessing feasibility of introducing therapeutic drug monitoring (TDM) for ocrelizumab into routine clinical practice based on collected data"}

Czechia

Earliest CTIS Part Ii Submission Date

08-08-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

393

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Fakultni Nemocnice Ostrava

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia