Trial · NCT02028884
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
NCT02028884, Phase 3, Completed, Hoffmann-La Roche; results first posted 2020-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD). Trials, record NCT02028884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02028884
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
- NCT number
- NCT02028884
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 85 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
- Interventions
- Satralizumab, Placebo, Baseline Treatment
- First posted
- 2014-01-07
- Last updated
- 2023-04-18
- Other registries' IDs
- eudract:2013-003752-21
- Results first posted
- 2020-12-31
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | Up to Week 224 | TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD) as adjudicated by an independent clinical endpoint committee (CEC). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse. |
| Secondary | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Baseline, Week 24 | The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = "no pain" and 100 = "pain as bad as it could be". Participants rated their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the "no pain" marker was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE). |
| Secondary | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Baseline, Week 24 | The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and SE. |
| Secondary | Relapse-Free Rate During the DB Period | Up to Week 216 | Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse. |
| Secondary | Annualized Relapse Rate (ARR) During the DB Period | Up to Week 216 | The ARR is calculated as the total number of participants with relapses experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred \< 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse. |
| Secondary | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement. |
| Secondary | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 168 | The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden. A negative change from baseline indicates an improvement. |
| Secondary | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement. |
| Secondary | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline up to Week 216 | Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement. |
| Secondary | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | Up to Week 224 | ITT population included all participants randomized to the treatment groups. For participants who had not relapsed, the TFR was censored on the date of end of the DB period. | weeks | MEDIAN |
| SECONDARY | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Baseline, Week 24 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data were imputed by baseline observation carried forward (BOCF) method. | score on scale | MEAN |
| SECONDARY | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Baseline, Week 24 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data was imputed using BOCF method | score on scale | MEAN |
| SECONDARY | Relapse-Free Rate During the DB Period | Up to Week 216 | ITT population included all participants randomized to the treatment groups. | percentage of participants | NUMBER |
| SECONDARY | Annualized Relapse Rate (ARR) During the DB Period | Up to Week 216 | ITT population included all participants randomized to the treatment groups. | patients w relapse/patient-years at risk | NUMBER |
| SECONDARY | Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 168 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period | Baseline up to Week 216 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. | LogMAR units | MEAN |
| SECONDARY | Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period | Baseline up to Week 216 | ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on scale | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group714
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | Placebo + Baseline Treatment | 120.6 | 95% Confidence Interval 37.0 to NA | weeks | |
| Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period | Satralizumab + Baseline Treatment | NA | 95% Confidence Interval NA to NA | weeks | |
| Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Placebo + Baseline Treatment | Baseline | 34.619 | Standard Error 4.026 | score on scale |
| Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Satralizumab + Baseline Treatment | Baseline | 27.561 | Standard Error 4.399 | score on scale |
| Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Placebo + Baseline Treatment | Change from Baseline at Week 24 | -3.505 | Standard Error 2.357 | score on scale |
| Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain During the DB Period | Satralizumab + Baseline Treatment | Change from Baseline at Week 24 | 2.871 | Standard Error 2.391 | score on scale |
| Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Placebo + Baseline Treatment | Baseline | 33.857 | Standard Error 1.746 | score on scale |
| Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Satralizumab + Baseline Treatment | Baseline | 34.732 | Standard Error 1.646 | score on scale |
| Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Placebo + Baseline Treatment | Change from Baseline at Week 24 | 2.234 | Standard Error 0.943 | score on scale |
| Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score During the DB Period | Satralizumab + Baseline Treatment | Change from Baseline at Week 24 | 0.145 | Standard Error 0.963 | score on scale |
1 to 10 of 714Source ClinicalTrials.gov
See all 714 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Placebo + Baseline Treatment, Then Satralizumab | 42 | |
| Double-blind Period | STARTED | Satralizumab + Baseline Treatment, Then Satralizumab | 42 | |
| Double-blind Period | STARTED | SA237 - Enrolled in Open-Label | 0 | |
| Double-blind Period | COMPLETED | Placebo + Baseline Treatment, Then Satralizumab | 32 | |
| Double-blind Period | COMPLETED | Satralizumab + Baseline Treatment, Then Satralizumab | 39 | |
| Double-blind Period | COMPLETED | SA237 - Enrolled in Open-Label | 0 | |
| Double-blind Period | NOT COMPLETED | Placebo + Baseline Treatment, Then Satralizumab | 10 | |
| Double-blind Period | NOT COMPLETED | Satralizumab + Baseline Treatment, Then Satralizumab | 3 | |
| Double-blind Period | NOT COMPLETED | SA237 - Enrolled in Open-Label | 0 | |
| Open-label Extension Period | STARTED | Placebo + Baseline Treatment, Then Satralizumab | 32 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events650
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Baseline Treatment Double Blind Period | 5 | 42 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Satralizumab + Baseline Treatment Double Blind Period | 3 | 42 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Baseline Treatment Open Label Period | 2 | 32 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Satralizumab + Baseline Treatment Open Label Period | 5 | 39 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Satralizumab Open-Label Period | 0 | 1 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo + Baseline Treatment Double Blind Period | 1 | 42 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Satralizumab + Baseline Treatment Double Blind Period | 2 | 42 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo + Baseline Treatment Open Label Period | 4 | 32 | 4 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Satralizumab + Baseline Treatment Open Label Period | 1 | 39 | 2 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Satralizumab Open-Label Period | 0 | 1 | 0 |
1 to 10 of 650Source ClinicalTrials.gov
See all 650 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Baseline Treatment Double Blind Period | 0 | 42 |
| Total, all-cause mortality | Satralizumab + Baseline Treatment Double Blind Period | 0 | 42 |
| Total, all-cause mortality | Placebo + Baseline Treatment Open Label Period | 0 | 32 |
| Total, all-cause mortality | Satralizumab + Baseline Treatment Open Label Period | 0 | 39 |
| Total, all-cause mortality | Satralizumab Open-Label Period | 0 | 1 |
| Total, other adverse events | Placebo + Baseline Treatment Double Blind Period | 37 | 42 |
| Total, other adverse events | Satralizumab + Baseline Treatment Double Blind Period | 35 | 42 |
| Total, other adverse events | Placebo + Baseline Treatment Open Label Period | 30 | 32 |
| Total, other adverse events | Satralizumab + Baseline Treatment Open Label Period | 30 | 39 |
| Total, other adverse events | Satralizumab Open-Label Period | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Baseline Treatment vs Satralizumab + Baseline Treatment: Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period | Trial comparisons |
| Placebo + Baseline Treatment vs Satralizumab + Baseline Treatment: Number of Participants With at Least One Serious Adverse Event in the DB Period | Trial comparisons |
| Placebo + Baseline Treatment vs Satralizumab + Baseline Treatment: Number of Participants With at Least One Adverse Event in the DB Period | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02028884
GET https://conductscience.org/api/trials/v1/NCT02028884/registered?page=2