NCT04688788Active, not recruitingPhase 3
Non-inferiority study of ocrelizumab and rituximab in active multiple sclerosis
Danish non-inferiority study of ocrelizumab and rituximab in MS: A randomized study comparing the efficacy of ocrelizumab and rituximab in active multiple sclerosis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Apr 2026
Brief summary (registry, in English)
The primary aim of the study is to test whether rituximab treatment is non-inferior to ocrelizumab treatment in active forms of multiple sclerosis, which will be evaluated with the primary endpoint percentage of patients with no new or enlarging T2 white matter lesions from month 6 to month 24. Patients completing the core-study of 24 months treatment, will be asked to continue in the extension study of additional 36 months duration.The extension long-term phase of the study (month 24 to month 60) willevaluate the long term efficacy and safety of rituximab and ocrelizumab therapy given as either standard dosing or extended interval dosing. The long-term phase of the study will examine whether extended interval dosing may be a preferable dosing strategy for patients who have been stable on well-established CD20-depleting therapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 28 Apr 2021
- Lead sponsor
- Rigshospitalet
- Diseases
- Multiple sclerosis
- NCT number
- NCT04688788
- EU CT number
- 2024-514287-84-00
- EudraCT number
- 2020-002981-15
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- Pregnancy or breast feeding • Lack of effective contraception (failure rate <1%) for women of child-bearing potential • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization • Active malignant disease in the previous 5 years • Positive test for HIV, hepatitis B or C, or tuberculosis • Negative test for varicella zoster • Lymphopenia grade 2 (0.5 to 0.8 × 109/L) or higher grades of lymphopenia (in case of switching from fingolimod, siponimod or ozanimod lymphopenia is accepted at screening visit (note that treatment with interferon-beta can induce transient lymphopenia) • Neutropenia grade 2 (1.0 to 1.5 × 109/L) or higher grades • Thrombocytopenia grade 2 (50 to 75 × 109/L) or higher grades • Previous treatment with alemtuzumab or hematopoietic stem-cell transplantation • Previous treatment with cladribine, CD20-depleting antibodies, daclizumab or other immune suppressive treatment which is judged to still exert immune suppressive effect by treating physician • Methylprednisolone treatment 4 weeks within baseline visit and baseline MRI scan • Findings on the screening MRI (for patients without MRI scan of the brain the previous 12 months the baseline MRI scan is also used as screening MRI) judged to preclude participation by the treating physician • Other diseases judged to be relevant by the treating physician • Contraindication to MRI • Known allergy or hypersensitivity to rituximab or ocrelizumab
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sygehus Sønderjylland, Aabenraa Coordinator of this site? Confirm its status | Aabenraa | Denmark | Active, not recruiting |
| Aalborg Universitetshospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Århus Universitets hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Esbjerg Hospital Coordinator of this site? Confirm its status | Esbjerg | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Active, not recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Active, not recruiting |
| Regionshospitalet Gødstrup Coordinator of this site? Confirm its status | Herning | Denmark | Active, not recruiting |
| Nordsjællands Hospital Hillerød Coordinator of this site? Confirm its status | København S | Denmark | Active, not recruiting |
| Kolding Hospital Coordinator of this site? Confirm its status | Kolding | Denmark | Active, not recruiting |
| Odense Universitetshospital Coordinator of this site? Confirm its status | Odense | Denmark | Active, not recruiting |
| Regionhospitalet Viborg Coordinator of this site? Confirm its status | Viborg | Denmark | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.