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Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease

Study acronym: OVERLORD-MS
StatusActive, Not Recruiting
PhasePhase 3
Started2020-11-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 27, 2025 (before its estimated August 14, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-06-24
Study Status, Oversight, Contacts/Locations v7
Primary completion date2025-05-14→2025-08-14
Completion date2025-05-14→2025-09-14
Study sites15→12
2023-08-30
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-02-14→2025-05-14
Completion date2025-02-14→2025-05-14
Enrollment targetestimated 211→confirmed 214
Study sitesdetails revised at 15 of 15 sites
2022-10-14
Study Status, Arms and Interventions v5
Re-verified, no change to tracked fields
2022-09-09
Study Status, Contacts/Locations v4
Study sites11→15
2022-03-18
Study Status v3
Re-verified, no change to tracked fields
Show 2 earlier versions
2021-03-17
Study Status, Eligibility, Contacts/Locations v2
Study sites6→11
Eligibility criteria-96 characters
[...] hs. Disease activity defined as ≥ 1 relapse3 or ≥ 1 new MRI lesion4lesion during the last 12 months EDSS score ≤ 4.0 Absence of comor [...] d et al. 2014) Any ongoing infection, including tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface ant [...] y treated with these medications for other diseases than MS Treatment with glucocorticoids or ACTH within one month prior to start of study treatment Previous use of MS-therapies such as natalizumab, fingolimod [...]
2020-11-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-10-15→confirmed 2020-11-02
Study sitesdetails revised at 6 of 6 sites
2020-09-30
Original filing
This is a multicenter non-inferiority study, designed to establish non-inferiority of the study treatment rituximab compared with the comparator ocrelizumab for consecutively included patients (male or female) with active relapsing-remitting multiple sclerosis aged 18-60 years.
Trial Details
NCT Number NCT04578639
Lead Sponsor Haukeland University Hospital
Collaborators: University Hospital, Akershus, Oslo University Hospital, Helse Stavanger HF, St. Olavs Hospital, University Hospital of North Norway
Conditions Relapsing Remitting Multiple Sclerosis
Enrollment 214 participants
Start Date 2020-11-02
Primary Completion 2025-08-14 (estimated)
Study Completion 2025-09-14 (estimated)
Updated on ClinicalTrials.gov 2025-06-27