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NCT Number: NCT05269004

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Español, Ciudad Autonoma Bs As, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Drug

Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Primary outcomes

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

    Time frame: Up to 44 months

Secondary outcomes

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

    Time frame: Week 0, 24, 48, 72, 96, 120, 168

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

    Time frame: Week 0, 24, 48, 72, 96, 120, 168

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

    Time frame: Week 0, 24, 48, 72, 96, 120, 168

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

    Time frame: 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

    Time frame: Week 0, 24, 48, 72, 96, 120, 168

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: OLERO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2022
Registry last updated
May 1, 2026

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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