N/A
Completed N=43
Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
Source: ClinicalTrials.gov NCT03157830 ↗Enrolled (actual)
43
Serious AEs
18.6%
Results posted
Sep 2024
Primary outcomePrimary: Relapse Free Survival at Month 12 — 95.2 Percentage of Participant Survival Rate
Summary
The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ) by evaluating relapse rate, progression on MRI and disability progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse Free Survival at Month 12 |
95.2 | — |
| SECONDARY Relapse Rate at Months 3, 6, and 9 |
100; 100; 97.67 | — |
| SECONDARY MRI Evidence of MS Disease Activity at Months 3, 6, and 12 |
92.31; 92.31; 92.31 | — |
| SECONDARY New or Enlarging T2 Lesions at 3, 6, and 12 Months |
4.65; 0; 0 | — |
| SECONDARY New Gd+ Lesions Detected at Months 3, 6, and 12 |
5.13; 0; 0 | — |
| SECONDARY Change in the EDSS Score From Baseline to Month 12 |
3.50; 3.50 | — |
| SECONDARY Change in MSIS-29 From Baseline to Months 6 and 12 |
-1.346; -1.283; 1.524; -0.6953 | — |
| SECONDARY Proportion of Patients That Discontinued OCR |
4.65 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female with relapsing form of MS, age 18 to 65, inclusive, at the time of informed consent.
- In the opinion of the investigator, able to understand the purpose and risk of the study and provide signed informed consent document.
- Must have received a stable dose of NTZ for 12 or more consecutive months, and have had no evidence of on-NTZ disease activity (clinically or on MRI) for the 6 months prior to the screening visit.
- Naïve to OCR.
- No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
- EDSS of ≤ 6.0 at screening.
- Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
Exclusion Criteria
- History of primary or secondary progressive multiple sclerosis.
- Evidence of active hepatitis B infection at screening.
- Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
- Patients with untreated hepatitis C or tuberculosis. Patients who have history of progressive multifocal leukoencephalopathy (PML) or known to be HIV positive, per standard care.
- Any persistent or severe infection.
- Pregnancy or lactation.
- Significant or uncontrolled somatic disease or severe depression in the last year.
- Inability to complete an MRI.
- Previous treatment with B-cell targeted therapies.
- Current use of immunosuppressive medication.
- Patients who have had evidence of disease activity within the 6 months prior to screening. This includes MS relapse, or new or enlarging T2 lesions or Gd+ enhancing lesions, or disability progression.
- Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
Data sourced from ClinicalTrials.gov (NCT03157830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.