Status:
RECRUITING
B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Rationale: B-cell depleting therapies like ocrelizumab are very effective in the treatment of relapsing remitting multiple sclerosis (RRMS). As B cell repopulation varies extensively between individua...
Eligibility Criteria
Inclusion
- A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria34
- EDSS score of 0 to 6.5
- Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion)
Exclusion
- Previous treatment with alemtuzumab, cladribine or stem cell transplantation
- Relapse in the past 3 months prior to inclusion
- Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion
- Inability to undergo regular MRI scanning
- Women who are pregnant or expect to become pregnant during the study period
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT05296161
Start Date
April 20 2022
End Date
March 1 2026
Last Update
April 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdam UMC, location VU
Amsterdam, North Holland, Netherlands, 1081 HV