The use of therapeutic monitoring of ocrelizumab serum concentrations for personalized pharmacotherapy of relapsing-remitting and primary progressive multiple sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Ostrava

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

16 Jun 2025 → ongoing

Decision date (initial)

2024-09-10

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fakultní nemocnice Ostrava

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 4

1. To determine serum concentrations of OCR in patients with RR and/or PP RS
2. To determine whether with the development of paraclinical and clinical parameters or with the prognosis of patients with RR and/or PP MS, the dose of OCR or the serum concentration of OCR is better correlated
3. To analyze the correlation of possible adverse effects of OCR with its measured serum concentration
4. 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

Conditions and MedDRA coding

Multiple Sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients diagnosed with RR and/or PP RS with already established or newly started OCR treatment
2. Men and women older than 18 years
3. Signing the Informed Consent to participate in the study
4. 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 5

1. Hypersensitivity to the medicinal substance or to any excipient
2. Current active infection
3. Patients in a severe immunocompromised state
4. Known active malignant disease
5. Pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 10

1. To determine serum concentrations of neurofilament light chains (ng/L)
2. To determine serum concentrations of glial fibrillary acidic protein (ng/L)
3. To determine the presence of antibodies against OCR (mg/L)
4. To determine the number of CD19+ cells (or other cells of the immune system that are associated with MS)
5. To determine the quality of life measured with the MSQOL-54 questionnaire (point value score)
6. To assess clinical status using the 25FWT, 9HPT and SDMT tests (point value score)
7. 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)
8. To determine disability progression (assessed as change on the EDSS scale)
9. To determine the course of MS (assessed as NEDA-3 concept)
10. To determine occurrence of relapses since the previous check-up (for patients with relapsing remitting MS)

Secondary endpoints 4

1. To determine serum concentrations of OCR in patients with RR and/or PP RS – observational goal
2. 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
3. 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
4. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Ostrava

Sponsor organisation

Fakultni Nemocnice Ostrava

Address

17. Listopadu 1790/5, Poruba Poruba

City

Ostrava

Postcode

708 00

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Ostrava

Contact name

Pavel Hradílek, MD, Ph.D.

Public contact point

Organisation

Fakultni Nemocnice Ostrava

Contact name

Pavel Hradílek, MD, Ph.D.

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 39 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications