Trial Outcomes & Findings for Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab (NCT NCT03157830)
NCT ID: NCT03157830
Last Updated: 2024-09-19
Results Overview
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
Recruitment status
COMPLETED
Target enrollment
43 participants
Primary outcome timeframe
12 Months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Ocrelizumab, OCREVUS
Patients eligible for this study will be receiving OCREVUS (also known as Ocrelizumab) as part of their routine care for multiple sclerosis (MS) treatment, and undergo the standard monitoring tests and procedures for multiple sclerosis (MS) patients receiving treatment. In addition, they will complete the Expanded Disability Status Scale (EDSS) scale on 6 occasions over a 12-month period, and the Multiple Sclerosis Impact Scale (MSIS-29) on three occasions during the 12 month period for research.
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|---|---|
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Overall Study
STARTED
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43
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Overall Study
COMPLETED
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41
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Ocrelizumab, OCREVUS
Patients eligible for this study will be receiving OCREVUS (also known as Ocrelizumab) as part of their routine care for multiple sclerosis (MS) treatment, and undergo the standard monitoring tests and procedures for multiple sclerosis (MS) patients receiving treatment. In addition, they will complete the Expanded Disability Status Scale (EDSS) scale on 6 occasions over a 12-month period, and the Multiple Sclerosis Impact Scale (MSIS-29) on three occasions during the 12 month period for research.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
Baseline characteristics by cohort
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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Age, Continuous
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43 Years
n=99 Participants
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Sex: Female, Male
Female
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33 Participants
n=99 Participants
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Sex: Female, Male
Male
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10 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=99 Participants
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Race (NIH/OMB)
White
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34 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=99 Participants
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Region of Enrollment
United States
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43 participants
n=99 Participants
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Disease duration
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11 Years
n=99 Participants
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PRIMARY outcome
Timeframe: 12 MonthsThe proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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Relapse Free Survival at Month 12
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95.2 Percentage of Participant Survival Rate
Interval 88.9 to 100.0
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SECONDARY outcome
Timeframe: 3, 6, and 9 monthsProportion of relapse-free patients at months 3, 6, and 9
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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Relapse Rate at Months 3, 6, and 9
Proportion of relapse-free patients at months 3
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100 percentage of relapse-free patients
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Relapse Rate at Months 3, 6, and 9
Proportion of relapse-free patients at months 6
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100 percentage of relapse-free patients
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Relapse Rate at Months 3, 6, and 9
Proportion of relapse-free patients at months 9
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97.67 percentage of relapse-free patients
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SECONDARY outcome
Timeframe: 3, 6, and 12 MonthsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing prior to MRI scans at month 3. Additionally two patients showed evidence of MRI activity prior to MRI scans.
Proportion of patients free from MRI evidence of MS disease activity at months 3, 6, and 12
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=41 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Proportion of patients free from MRI evidence of MS disease activity at 6 months
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92.31 percentage of patients free from MRI evi
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MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Proportion of patients free from MRI evidence of MS disease activity at 12 months
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92.31 percentage of patients free from MRI evi
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MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Proportion of patients free from MRI evidence of MS disease activity at 3 months
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92.31 percentage of patients free from MRI evi
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SECONDARY outcome
Timeframe: 3, 6, and 12 monthsProportion of patients with New or Enlarging T2 lesions at 3, 6, and 12 months. For patients with New or Enlarging T2 lesions, number of New and Enlarging T2 lesions.
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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New or Enlarging T2 Lesions at 3, 6, and 12 Months
Proportion of participants with new or enlarging T1 and/or T2 lesions at 3 months
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4.65 percentage of participants with new or e
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New or Enlarging T2 Lesions at 3, 6, and 12 Months
Proportion of participants with new or enlarging T1 and/or T2 lesions at 6 months
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0 percentage of participants with new or e
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New or Enlarging T2 Lesions at 3, 6, and 12 Months
Proportion of participants with new or enlarging T1 and/or T2 lesions at 12 months
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0 percentage of participants with new or e
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SECONDARY outcome
Timeframe: 3, 6, and 12 monthsProportion of patients with New Gd+ lesions detected at months 3, 6, and 12. For patients with New Gd+ lesions, number of New Gd+ lesions
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=39 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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New Gd+ Lesions Detected at Months 3, 6, and 12
Proportion of patients with new Gd+ lesions at 3 months
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5.13 percentage of participants with new Gd+
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New Gd+ Lesions Detected at Months 3, 6, and 12
Proportion of patients with new Gd+ lesions at 6 months
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0 percentage of participants with new Gd+
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New Gd+ Lesions Detected at Months 3, 6, and 12
Proportion of patients with new Gd+ lesions at 12 months
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0 percentage of participants with new Gd+
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SECONDARY outcome
Timeframe: 12 monthsAverage change in EDSS score. The Expanded Disability Status Scale (EDSS) is an assessment used by neurologist to assess changes in the level of disability over time in patients with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scores are also based on measures of impairment in the 8 functional systems. Higher scores indicate greater impact of MS on QoL.
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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Change in the EDSS Score From Baseline to Month 12
Baseline
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3.50 Score on EDSS
Interval 1.0 to 6.0
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Change in the EDSS Score From Baseline to Month 12
Month 12
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3.50 Score on EDSS
Interval 1.0 to 6.5
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SECONDARY outcome
Timeframe: 6 and 12 monthsAverage change in MSIS-29: Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Scores from individual items are summed to a total score. Physical impact score ranges from 20-80 and psychological impact scores ranges from 9-36. Higher scores indicate greater impact of MS on QoL.
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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Change in MSIS-29 From Baseline to Months 6 and 12
Physical - Baseline to Month 6
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-1.346 score on MSIS29 Scale
Interval -1.763 to 4.455
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Change in MSIS-29 From Baseline to Months 6 and 12
Psychological - Baseline to Month 6
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-1.283 score on MSIS29 Scale
Interval -2.086 to 0.4455
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Change in MSIS-29 From Baseline to Months 6 and 12
Physical - Baseline to Month 12
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1.524 score on MSIS29 Scale
Interval -5.085 to 2.036
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Change in MSIS-29 From Baseline to Months 6 and 12
Psychological - Baseline to Month 12
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-0.6953 score on MSIS29 Scale
Interval -3.225 to 4.616
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SECONDARY outcome
Timeframe: 12 monthsProportion of patients that stop treatment with OCR for any reason
Outcome measures
| Measure |
Ocrelizumab, OCREVUS
n=43 Participants
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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Proportion of Patients That Discontinued OCR
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4.65 percentage of participants
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Adverse Events
Ocrelizumab, OCREVUS
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocrelizumab, OCREVUS
n=43 participants at risk
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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Infections and infestations
Urinary tract infection
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2.3%
1/43 • Number of events 1 • 12 months
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Nervous system disorders
Seizure
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2.3%
1/43 • Number of events 1 • 12 months
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Reproductive system and breast disorders
Spontaneous abortion
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2.3%
1/43 • Number of events 1 • 12 months
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Vascular disorders
Chronic venous hypertension with symptomatic varicose veins, left leg
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2.3%
1/43 • Number of events 1 • 12 months
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Endocrine disorders
Diabetic ketoacidosis
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4.7%
2/43 • Number of events 2 • 12 months
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Immune system disorders
Anaphylaxis
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2.3%
1/43 • Number of events 1 • 12 months
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Immune system disorders
Acute encephalopathy
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2.3%
1/43 • Number of events 1 • 12 months
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Renal and urinary disorders
Acute cystitis without hematuria
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2.3%
1/43 • Number of events 1 • 12 months
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Renal and urinary disorders
Acute kidney injury
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4.7%
2/43 • Number of events 2 • 12 months
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Renal and urinary disorders
Acute renal failure
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2.3%
1/43 • Number of events 1 • 12 months
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Reproductive system and breast disorders
Malignancy, right breast*
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2.3%
1/43 • Number of events 1 • 12 months
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Other adverse events
| Measure |
Ocrelizumab, OCREVUS
n=43 participants at risk
Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.
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|---|---|
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General disorders
Infusion related reaction
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72.1%
31/43 • Number of events 31 • 12 months
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Infections and infestations
Respiratory tract infection
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27.9%
12/43 • Number of events 12 • 12 months
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Infections and infestations
Urinary tract infection
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16.3%
7/43 • Number of events 7 • 12 months
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Additional Information
Director of PBSI /WC Clinical Research Program
Providence Health & Services
Phone: (503) 216-1012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place