Last reviewed · How we verify
Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset (IMPACT MS)
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients will be treated with ocrelizumab at disease onset to see if treatment favorably alters CSF markers of chronic inflammation.
Details
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 30 |
| Start date | 2020-08-30 |
| Completion | 2027-07 |
Conditions
- Relapsing Multiple Sclerosis
- Clinically Isolated Syndrome
Interventions
- Ocrelizumab
Primary outcomes
- Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab — 3 years
Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after 3 years of treatment with ocrelizumab. Intrathecal synthesis is measured by either a) normalization of the IgG Index (0.6 is the upper limit of normal) or b) eradication of oligoclonal bands
Countries
United States