Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02688985

Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

Multiple Sclerosis, Primary Progressive Clinical Trial

Official title:
An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis

Clinical Trial Summary

This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4 [control group]) will not be a part of the randomization and will be recruited separately, wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline. PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the start of the study before dosing with ocrelizumab and second LP at Week 52 following the first dose of ocrelizumab. A long-term extension will be conducted for participants that complete the study and continue to receive ocrelizumab. Treatment with ocrelizumab in the entire study will continue for approximately 4.5 years after the first infusion.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02688985
Study type Interventional
Source Genentech, Inc.
Contact
Status Completed
Phase Phase 3
Start date April 29, 2016
Completion date April 11, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03455582 - Cognition Evolution and MRI Markers in PPMS Patients on 2 Years N/A
Active, not recruiting NCT04544449 - A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis Phase 3
Completed NCT06436131 - The Effects of In-phase Bilateral Exercise in People With Progressive Multiple Sclerosis N/A
Recruiting NCT04918225 - Motor Asymmetry in Progressive Multiple Sclerosis Patients
Completed NCT02913157 - Hydroxychloroquine in Primary Progressive Multiple Sclerosis Phase 2
Completed NCT01982942 - Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis Phase 2
Recruiting NCT05204459 - MS-ResearchBiomarkerS
Completed NCT05663853 - An Observational Biomarker Study in Multiple Sclerosis (MS) Patients
Completed NCT01194570 - A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis Phase 3
Completed NCT02305264 - Imaging of Intracerebral Inflammation in MS N/A
Completed NCT03679468 - Improving Cognition in People With Progressive Multiple Sclerosis Using Aerobic Exercise and Cognitive Rehabilitation N/A
Recruiting NCT05496881 - Exercise Effects in Multiple Sclerosis N/A
Completed NCT02506751 - Open-label Study of Liothyronine in MS Phase 1
Temporarily not available NCT02606929 - Use of Well Known Drugs for New Destination - MS Improvement (MSNT) Phase 0
Completed NCT03424538 - The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients N/A
Completed NCT04545372 - Aerobic Exercises for Multiple Sclerosis N/A
Recruiting NCT05122559 - Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT02988401 - Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis Phase 1/Phase 2
Completed NCT02632591 - Use on Human Beings of Mix of Known Drugs for New Destination - MS Treatment Phase 1
Completed NCT01917019 - A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis Phase 3