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Eine Studie zur Beurteilung der Wirksamkeit, Sicherheit und Pharmakokinetik einer höheren Ocrelizumab-Dosis in der Behandlung von Patient*innen mit schubförmiger Multipler Sklerose
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
- Autoimmunerkrankung
- Multiple Sklerose (MS)
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Aktiv, keine Rekrutierung
Diese Studie läuft in
Städte
- Berlin
- Bochum
- Dresden
- Kiel
- Leipzig
- Tübingen
- Ulm
- Wiesbaden
Studien-ID:
NCT04544436 2023-506467-34-00 BN42082
Studienzusammenfassung
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04544436,BN42082,2023-506467-34-00
Studien-ID
Ocrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone
Treatments
Multiple Sclerosis
Condition
Official Title
A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis
Einschlusskriterien
All
Gender
≥18 Years & ≤ 55 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Diagnosis of relapsing multiple sclerosis (RMS).
- At least two documented clinical attacks within the last 2 years prior to screening, or one clinical attack in the year prior to screening. No relapse 30 days prior to screening and at baseline.
- Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
- Expanded disability status scale (EDSS), at screening and baseline, from 0 to 5.5 inclusive.
- Documented MRI of brain with abnormalities consistent with MS prior to screening.
- Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
- For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
- For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile
Exclusion Criteria
- History of primary progressive MS at screening.
- Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening.
- History of confirmed or suspected progressive multifocal leukoencephalopathy.
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.
- Immunocompromised state.
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
- Inability to complete an MRI or contraindication to gadolinium administration.
- Contraindications to mandatory pre-medications for IRRs.
- Known presence of other neurologic disorders.
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
- Significant, uncontrolled disease that may preclude participant from participating in the study.
- History of or currently active primary or secondary, non-drug-related, immunodeficiency.
- Pregnant or breastfeeding or intending to become pregnant.
- Lack of peripheral venous access.
- History of alcohol or other drug abuse within 12 months prior to screening.
- Treatment with any investigational agent or treatment with any experimental procedure for MS.
- Previous use of anti-CD20s if in the last 2 years before screening, or if B-cell count is not normal, or if treatment was stopped due to safety reasons or lack of efficacy.
- Previous use of mitoxantrone, cladribine, atacicept, and alemtuzumab.
- Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label.
- If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication.
- Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.
- Any previous history of transplantation or anti-rejection therapy.
- Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization.
- Systemic corticosteroid therapy within 4 weeks prior to screening.
- Positive screening tests for active, latent, or inadequately treated hepatitis B.
- Sensitivity or intolerance to any ingredient of ocrelizumab.
- Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.
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