Ocrelizumab
DrugAdministered by subcutaneous Injection
NCT Number: NCT03972306
This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
University of Colorado, Aurora, Colorado, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks)
Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).
Exclusion criteria
Administered by subcutaneous Injection
Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
Time frame: At predefined intervals from baseline through end of study (approximately 5 years)
Time frame: At predefined intervals from baseline through end of study (approximately 5 years)
Time frame: Baseline to end of study (approximately 5 years)
Time frame: Baseline to end of study (approximately 5 years)
Time frame: Baseline to end of study (approximately 5 years)
Time frame: Baseline to end of study (approximately 5 years)
Time frame: Baseline to end of study (approximately 5 years)
Time frame: Baseline to end of study (approximately 5 years)
Hoffmann-La Roche
Industry
A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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