Running, not recruitingPhase 3Relapsing and progressiveNCT052690042023-505974-14-002021-005746-15

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

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

    Up to 44 months

    Safety
  • 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

    Safety

Other measures (6)

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

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

    Disability progression
  • Change in 9-Hole Peg Test (9HPT) over time

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

    Disability progression
  • Change in Timed 25-Foot Walk Test (T25FWT) over time

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

    Disability progressionWalking and mobility
  • The number of T1 lesions and number of new or enlarging T2 lesions

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

    MRI lesions
  • The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume

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

    MRI lesions
  • 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time

    Disability progressionWalking and mobility

Who could take part

Relapsing and progressive · 18 to 64

Inclusion criteria * 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 Exclusion criteria * Concurrent participation in any clinical trial (other than the Parent study) * Unable or unwilling to comply with the requirements of the protocol

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Linked trials

    • Extended by

      OleroMAX

      Phase 3 · Recruiting

    Links found where a registry record names another trial's registry number.

    Related trials

    History

      1. Started

        May 2022

      2. Main results due

        Dec 2027

      3. Finished

        Dec 2027

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