An observational study in Relapsing Remitting Multiple Sclerosis, sponsored by Providence Health & Services. Completed at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Providence Health & Services · Observational
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.
This is a multicenter, prospective, open-label, Phase IV clinical trial. Patients with relapsing forms of Multiple Sclerosis (MS), ages 18 to 65, who have received a stable dose of NTZ for 12 or more consecutive months, and have been free of relapses, disability worsening or Magnetic Resonance Imaging (MRI) progression 6 months prior to the transition screening visit will be eligible for the study. After informed consent to participate has been obtained, the patient will have physical exam (PE), non-blinded Expanded Disability Status Scale (EDSS), MRI, Multiple Sclerosis Impact Scale (MSIS-29) and labs done for the screening visit to determine eligibility. Brain MRI with and without contrast will be performed with the standard MS protocol. MRIs will be performed with 3mm slice thickness with no gaps between slices. Patients will receive their first dose of OCR 4 to 6 weeks after the last dose of NTZ. Other baseline measures, including physical exam, EDSS, MSIS-29, and labs will be performed within 4 weeks of screening. Physical exam, non-blinded EDSS, and labs will be performed at month 3, month 6, month 9, and month 12. MSIS-29 will be performed at months 6 and 12. In addition, MRIs will be performed at months 3, 6, and 12.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 43 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Providence Health & Services is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female patients with relapsing forms of MS, ages 18 to 65, must have received a stable dose of NTZ for 12 or more consecutive months, and have been free of relapses, disability worsening or MRI progression 6 months prior to switching from NTZ to OCR therapy are eligible to participate.
Exclusion Criteria:
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.
Relapse Free Survival at Month 12
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
Time frame: 12 Months
Relapse Rate at Months 3, 6, and 9
Proportion of relapse-free patients at months 3, 6, and 9
Time frame: 3, 6, and 9 months
MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Proportion of patients free from MRI evidence of MS disease activity at months 3, 6, and 12
Time frame: 3, 6, and 12 Months
New or Enlarging T2 Lesions at 3, 6, and 12 Months
Proportion 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.
Time frame: 3, 6, and 12 months
New Gd+ Lesions Detected at Months 3, 6, and 12
Proportion of patients with New Gd+ lesions detected at months 3, 6, and 12. For patients with New Gd+ lesions, number of New Gd+ lesions
Time frame: 3, 6, and 12 months
Change in the EDSS Score From Baseline to Month 12
Average 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.
Time frame: 12 months
Change in MSIS-29 From Baseline to Months 6 and 12
Average 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.
Time frame: 6 and 12 months
Proportion of Patients That Discontinued OCR
Proportion of patients that stop treatment with OCR for any reason
Time frame: 12 months
| Milestone | Ocrelizumab, OCREVUS |
|---|---|
| Started | 43 |
| Completed | 41 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 1 |
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
| Percentage of Participant Survival Rate | Ocrelizumab, OCREVUS |
|---|---|
| Relapse Free Survival at Month 12 | 95.2 (88.9 to 100) |
Proportion of relapse-free patients at months 3, 6, and 9
| percentage of relapse-free patients | Ocrelizumab, OCREVUS |
|---|---|
| Proportion of relapse-free patients at months 3 | 100 |
| Proportion of relapse-free patients at months 6 | 100 |
| Proportion of relapse-free patients at months 9 | 97.67 |
Proportion of patients free from MRI evidence of MS disease activity at months 3, 6, and 12
| percentage of patients free from MRI evi | Ocrelizumab, OCREVUS |
|---|---|
| Proportion of patients free from MRI evidence of MS disease activity at 3 months | 92.31 |
| Proportion of patients free from MRI evidence of MS disease activity at 6 months | 92.31 |
| Proportion of patients free from MRI evidence of MS disease activity at 12 months | 92.31 |
Proportion 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.
| percentage of participants with new or e | Ocrelizumab, OCREVUS |
|---|---|
| Proportion of participants with new or enlarging T1 and/or T2 lesions at 3 months | 4.65 |
| Proportion of participants with new or enlarging T1 and/or T2 lesions at 6 months | 0 |
| Proportion of participants with new or enlarging T1 and/or T2 lesions at 12 months | 0 |
Proportion of patients with New Gd+ lesions detected at months 3, 6, and 12. For patients with New Gd+ lesions, number of New Gd+ lesions
| percentage of participants with new Gd+ | Ocrelizumab, OCREVUS |
|---|---|
| Proportion of patients with new Gd+ lesions at 3 months | 5.13 |
| Proportion of patients with new Gd+ lesions at 6 months | 0 |
| Proportion of patients with new Gd+ lesions at 12 months | 0 |
Average 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.
| Score on EDSS | Ocrelizumab, OCREVUS |
|---|---|
| Baseline | 3.50 (1 to 6) |
| Month 12 | 3.50 (1 to 6.5) |
Average 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.
| score on MSIS29 Scale | Ocrelizumab, OCREVUS |
|---|---|
| Physical - Baseline to Month 6 | -1.346 (-1.763 to 4.455) |
| Psychological - Baseline to Month 6 | -1.283 (-2.086 to 0.4455) |
| Physical - Baseline to Month 12 | 1.524 (-5.085 to 2.036) |
| Psychological - Baseline to Month 12 | -0.6953 (-3.225 to 4.616) |
Proportion of patients that stop treatment with OCR for any reason
| percentage of participants | Ocrelizumab, OCREVUS |
|---|---|
| Proportion of Patients That Discontinued OCR | 4.65 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocrelizumab, OCREVUS | 0/43 (0%) | 8/43 (18.6%) | 36/43 (83.7%) |
| Event | Ocrelizumab, OCREVUS |
|---|---|
| Diabetic ketoacidosisEndocrine disorders | 2/43 |
| Acute kidney injuryRenal and urinary disorders | 2/43 |
| Urinary tract infectionInfections and infestations | 1/43 |
| SeizureNervous system disorders | 1/43 |
| Spontaneous abortionReproductive system and breast disorders | 1/43 |
| Chronic venous hypertension with symptomatic varicose veins, left legVascular disorders | 1/43 |
| AnaphylaxisImmune system disorders | 1/43 |
| Acute encephalopathyImmune system disorders | 1/43 |
| Acute cystitis without hematuriaRenal and urinary disorders | 1/43 |
| Acute renal failureRenal and urinary disorders | 1/43 |
| Event | Ocrelizumab, OCREVUS |
|---|---|
| Infusion related reactionGeneral disorders | 31/43 |
| Respiratory tract infectionInfections and infestations | 12/43 |
| Urinary tract infectionInfections and infestations | 7/43 |
| Age, Continuous(Years) | Ocrelizumab, OCREVUS |
|---|---|
| Median | 43 (20 to 64) |
| Sex: Female, Male(Participants) | Ocrelizumab, OCREVUS |
|---|---|
| Female | 33 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Ocrelizumab, OCREVUS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 34 |
| More than one race | 2 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Ocrelizumab, OCREVUS |
|---|---|
| United States | 43 |
| Disease duration(Years) | Ocrelizumab, OCREVUS |
|---|---|
| Median | 11 (1 to 29) |
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Providence Health & Services