A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

NCT05269004
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,300
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Lead sponsor
Hoffmann-La Roche
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Start date
2022-05-03
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Number of sites
236
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Summary
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
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Acronym
OLERO
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Short title
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
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Official title
A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-12-31
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First posted
2022-03-07
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Registry last updated
2026-07-29
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Primary completion date
2027-12-31
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Start date
2022-05-03
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Participants
1,300
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Participant count basis
Estimated
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Planned participants
1,300
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Protocol amendments
0
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Number of sites
236
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Hoffmann-La Roche
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05269004
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ClinicalTrials.gov ID
NCT05269004
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0

    Timeframe: Up to 44 months

  1. Change in Expanded Disability Status Scale (EDSS) score over time

    Timeframe: Week 0, 24, 48, 72, 96, 120, 168

  2. Change in 9-Hole Peg Test (9HPT) over time

    Timeframe: Week 0, 24, 48, 72, 96, 120, 168

  3. Change in Timed 25-Foot Walk Test (T25FWT) over time

    Timeframe: Week 0, 24, 48, 72, 96, 120, 168

  4. The number of T1 lesions and number of new or enlarging T2 lesions

    Timeframe: Week 0, 24, 48, 72, 96, 120, 168

  5. The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume

    Timeframe: Week 0, 24, 48, 72, 96, 120, 168

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet

  • Concurrent participation in any clinical trial (other than the Parent study)
  • Unable or unwilling to comply with the requirements of the protocol
Sources for eligibility
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  • Barrow Neurological InstitutePhoenix, United States
  • Arizona Neuroscience Research LLCPhoenix, United States
  • MS Center of CaliforniaLaguna Hills, United States
  • Stanford Hospital and ClinicsPalo Alto, United States
  • University of California San FranciscoSan Francisco, United States
  • University of California San FranciscoSan Francisco, United States
  • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)Aurora, United States
  • Advanced Neurosciences Research LLCFort Collins, United States
  • Neurology Associates PAMaitland, United States
  • University of MiamiMiami, United States
  • Neurological Services of OrlandoOrlando, United States
  • University of South FloridaTampa, United States
  • Vero Beach Neurology and Research InstituteVero Beach, United States
  • Atlanta Neuroscience InstituteAtlanta, United States
  • Northwestern UniversityChicago, United States
  • Consultants in Neurology LtdNorthbrook, United States
  • Indiana Univ School of MedIndianapolis, United States
  • Kansas University Medical CenterKansas City, United States
  • Massachusetts General HospitalBoston, United States
  • Wayne State UniversityDetroit, United States
  • Henry Ford HospitalDetroit, United States
  • Michigan Institute for Neurological DisordersFarmington Hills, United States
  • Minneapolis Clinic of NeurologyGolden Valley, United States
  • University of MinnesotaMinneapolis, United States
  • Washington UniversitySt Louis, United States

And 211 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2021-005746-15
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)