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Safety of Switching From Rituximab to Ocrelizumab in MS Patients
Phase 3 trial testing Ocrelizumab in Multiple Sclerosis in 200 participants. Completed in 6 March 2019.
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 January 2017 |
| Primary completion | 6 March 2019 |
| Estimated completion | 6 March 2019 |
| Sites | 1 location across United States |
University of Colorado, Denver
Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The investigators will report the proportion of infusions with \>= 1 IRR (infusion-related reaction) between the switching and comparator groups. Data was collected at Day 1, Day 15, and Week 24 and combined to determine the overall proportion of IRRs over the life of the study.
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 10 | |
| Comparator Group | 14 |
The investigators will report the difference in the total number of IRRs after each infusion of ocrelizumab compared to combined rituximab infusions in the comparator group.
| Group | Value | 95% CI |
|---|---|---|
| Comparator Group | 28 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 12 |
The severity of IRRs will be assessed following each infusion of ocrelizumab in the switching and comparator group using the National Cancer Institute's Common Terminology for Adverse Events Scale (Grades range from 1-5, with higher Grades indicating more severe reactions). The frequency of each severity grade of IRR will be compared in a similar fashion .
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 86 | |
| Comparator Group | 172 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 8 | |
| Comparator Group | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 6 | |
| Comparator Group | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 0 | |
| Comparator Group | 0 |
The severity of IRRs will be assessed following each infusion of ocrelizumab in the switching and comparator group using the National Cancer Institute's Common Terminology for Adverse Events Scale (Grades range from 1-5, with higher Grades indicating more severe reactions). The frequency of each severity grade of IRR will be compared in a similar fashion.
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 96 | |
| Comparator Group | 172 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 0 | |
| Comparator Group | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 4 | |
| Comparator Group | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 0 | |
| Comparator Group | 0 |
The severity of IRRs will be assessed following each infusion of ocrelizumab in the switching and comparator group using the National Cancer Institute's Common Terminology for Adverse Events Scale (Grades range from 1-5, with higher Grades indicating more severe reactions). The frequency of each severity grade of IRR will be compared in a similar fashion .
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 88 | |
| Comparator Group | 172 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 9 | |
| Comparator Group | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 3 | |
| Comparator Group | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Switching Group | 0 | |
| Comparator Group | 0 |
We will also compare the proportion of patients with an IRR following day 1 infusion versus the proportion of patients with an IRR at day 15 and month 6 infusions of ocrelizumab in the switching group.
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 Infusion | 14 | |
| Switching Group - Day 15 Infusion | 4 | |
| Switching Group - Week 24 Infusion | 12 |
Proportion of ocrelizumab patients who test positive for ocrelizumab anti-drug anti-bodies
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 Infusion | 1.00 | 0.03 – 5.45 |
| Switching Group - Week 24 Infusion | 1.00 | 0.03 – 5.45 |
Proportion of patients who test positive for rituximab anti-drug anti-bodies.
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 | 16.00 | 8.81 – 23.19 |
| Switching Group - Week 24 | 7.00 | 2.86 – 13.89 |
Proportion of patients with CD19% \<= 1%.
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 | 57.14 | 47.35 – 66.94 |
| Switching Group - Week 24 | 92.00 | 84.84 – 96.48 |
| Switching Group - 1 Year | 90.32 | 82.42 – 95.48 |
Proportion of patients with CD20% \<= 1%
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 | 56.70 | 46.84 – 66.56 |
| Switching Group - Week 24 | 92.00 | 84.84 – 96.48 |
| Switching Group - 1 Year | 88.64 | 82.01 – 95.27 |
Comparing Eotaxin concentration between pre and post ocrelizumab infusion - Day 1
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 - Pre Infusion | 117.44 | ± 50.19 |
| Switching Group - Day 1 - Post Infusion | 101.41 | ± 55.94 |
Comparing IFN-gamma concentration between pre and post ocrelizumab infusion - Day 1
| Group | Value | 95% CI |
|---|---|---|
| Switching Group - Day 1 - Pre Infusion | 2.03 | ± 1.42 |
| Switching Group - Day 1 - Post Infusion | 4.58 | ± 5.28 |
Time frame: 1 year - enrollment to month 12 infusion.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Switching Group | Comparator Group |
|---|---|---|---|
| clostridium difficile colitis | Gastrointestinal disorders | — | — |
| Sepsis | Immune system disorders | — | — |
| Hip Dislocation | Musculoskeletal and connective tissue disorders | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Unknown pulmonary complications | Respiratory, thoracic and mediastinal disorders | — | — |
| Liver and renal failure | Renal and urinary disorders | — | — |
| Hyperammonemia | Metabolism and nutrition disorders | — | — |
| Acute Encephalopathy | General disorders | — | — |
| Reaction | System | Switching Group | Comparator Group |
|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Headache | General disorders | — | — |
| Nausea | General disorders | — | — |
| Numbness | General disorders | — | — |
Most-reported serious reactions: clostridium difficile colitis, Sepsis, Hip Dislocation, Pneumonia, Unknown pulmonary complications, Liver and renal failure, Hyperammonemia, Acute Encephalopathy.
Data from ClinicalTrials.gov NCT02980042 adverse events section.
This is a prospective between and within group observational study to determine differences in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS) patients who have been administered at least two infusions of rituximab, six months apart and are willing to be switched to ocrelizumab compared to a 100 patients who are continuing on rituximab as a comparison cohort from the clinic population treated as part of clinical care.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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