Trial · NCT04667949
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
NCT04667949, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2025-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients. Trials, record NCT04667949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04667949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
- NCT number
- NCT04667949
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 98 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Interventions
- Fingolimod 0.5mg
- First posted
- 2020-12-16
- Last updated
- 2026-01-13
- Other registries' IDs
- eudract:2024-000601-32
- Results first posted
- 2025-08-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Annualized Relapse Rate (ARR) in Adult Group | Baseline to Month 24 | A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician. The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained. As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study. For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity. |
| Secondary | Annualized Rate of the Number of New or Newly Enlarged T2 Lesions | Baseline to end of treatment (up to Month 24) | Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable. The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset. Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group. |
| Secondary | Change From Baseline in Number of New or Newly Enlarged T2 Lesions | Baseline up to Month 24 | Number of new/newly enlarged T2 lesions since baseline as measured by MRI |
| Secondary | Change From Baseline in T2 Lesion Volume | Baseline up to Month 24 | T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value |
| Secondary | Number of Gd-enhancing T1 Lesions Per Scan in Adult Group | Baseline up to Month 24 | Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable. The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset. MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group. |
| Secondary | Number of Gd-enhancing T1 Lesions | Baseline up to Month 24 | Number of Gd-enhancing T1 lesions as measured by MRI |
| Secondary | Change From Baseline in Gd-enhancing T1 Lesion Volume | Baseline up to Month 24 | Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value |
| Secondary | Number of T1 Hypo-intense Lesions | Baseline up to Month 24 | Number of T1 hypo-intense lesions as measured by MRI |
| Secondary | Change From Baseline in T1 Hypo-intense Lesion Volume | Baseline up to Month 24 | T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value |
Source ClinicalTrials.gov
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| POST_HOC | Participant Based Annualized Relapse Rate (ARR) | Baseline to Month 24 | Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | relapses per participant-year | MEAN |
| POST_HOC | Time Based Annualized Relapse Rate (ARR) | Baseline to Month 24 | Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | relapses per participant-year | NUMBER |
| PRIMARY | Adjusted Annualized Relapse Rate (ARR) in Adult Group | Baseline to Month 24 | Adult participants in the Full Analysis Set (FAS). FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | relapses per participant-year | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Annualized Rate of the Number of New or Newly Enlarged T2 Lesions | Baseline to end of treatment (up to Month 24) | Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure.. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Lesions per participant-year | NUMBER |
| SECONDARY | Change From Baseline in Number of New or Newly Enlarged T2 Lesions | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | new / newly enlarged T2 lesions | MEAN |
| SECONDARY | Change From Baseline in T2 Lesion Volume | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | milliliters | MEDIAN |
| SECONDARY | Number of Gd-enhancing T1 Lesions Per Scan in Adult Group | Baseline up to Month 24 | Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Lesions per participant per scan | NUMBER |
| SECONDARY | Number of Gd-enhancing T1 Lesions | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | T1 lesions | MEAN |
| SECONDARY | Change From Baseline in Gd-enhancing T1 Lesion Volume | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | microliters | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participant Based Annualized Relapse Rate (ARR) | Fingolimod (< 18 Years) | All relapses - Participant based | 0.1952 | Standard Deviation 0.50314 | relapses per participant-year |
| Participant Based Annualized Relapse Rate (ARR) | Fingolimod > 18 Years | All relapses - Participant based | 0.0969 | Standard Deviation 0.50002 | relapses per participant-year |
| Participant Based Annualized Relapse Rate (ARR) | Fingolimod (< 18 Years) | Confirmed relapses - Participant based | 0.0460 | Standard Deviation 0.15253 | relapses per participant-year |
| Participant Based Annualized Relapse Rate (ARR) | Fingolimod > 18 Years | Confirmed relapses - Participant based | 0.0372 | Standard Deviation 0.24424 | relapses per participant-year |
| Time Based Annualized Relapse Rate (ARR) | Fingolimod (< 18 Years) | All relapses - Time based | 0.161 | relapses per participant-year | |
| Time Based Annualized Relapse Rate (ARR) | Fingolimod > 18 Years | All relapses - Time based | 0.065 | relapses per participant-year | |
| Time Based Annualized Relapse Rate (ARR) | Fingolimod (< 18 Years) | Confirmed relapses - Time based | 0.054 | relapses per participant-year | |
| Time Based Annualized Relapse Rate (ARR) | Fingolimod > 18 Years | Confirmed relapses - Time based | 0.019 | relapses per participant-year | |
| Adjusted Annualized Relapse Rate (ARR) in Adult Group | Fingolimod > 18 Years | 0.018 | 95% Confidence Interval 0.006 to 0.061 | relapses per participant-year | |
| Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | Fingolimod (< 18 Years) | Adverse events (AEs) | 11 | Participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod (< 18 Years) | 11 | |
| Overall Study | STARTED | Fingolimod > 18 Years | 87 | |
| Overall Study | COMPLETED | Fingolimod (< 18 Years) | 10 | |
| Overall Study | COMPLETED | Fingolimod > 18 Years | 75 | |
| Overall Study | NOT COMPLETED | Fingolimod (< 18 Years) | 1 | |
| Overall Study | NOT COMPLETED | Fingolimod > 18 Years | 12 |
Source ClinicalTrials.gov
Adverse events249
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 | Hypoglobulinaemia | Blood and lymphatic system disorders | Less Than 18 Years | 1 | 11 | |
| other | Hypoglobulinaemia | Blood and lymphatic system disorders | Greater Than or Equal to 18 Years | 2 | 87 | |
| other | Hypoglobulinaemia | Blood and lymphatic system disorders | Overall | 3 | 98 | |
| other | Leukopenia | Blood and lymphatic system disorders | Less Than 18 Years | 5 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | Greater Than or Equal to 18 Years | 22 | 87 | |
| other | Leukopenia | Blood and lymphatic system disorders | Overall | 27 | 98 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Less Than 18 Years | 7 | 11 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Greater Than or Equal to 18 Years | 24 | 87 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Overall | 31 | 98 | |
| other | Neutropenia | Blood and lymphatic system disorders | Less Than 18 Years | 3 | 11 |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Less Than 18 Years | 0 | 11 |
| Total, all-cause mortality | Greater Than or Equal to 18 Years | 0 | 87 |
| Total, all-cause mortality | Overall | 0 | 98 |
| Total, other adverse events | Less Than 18 Years | 11 | 11 |
| Total, other adverse events | Greater Than or Equal to 18 Years | 85 | 87 |
| Total, other adverse events | Overall | 96 | 98 |
| Total, serious adverse events | Less Than 18 Years | 3 | 11 |
| Total, serious adverse events | Greater Than or Equal to 18 Years | 12 | 87 |
| Total, serious adverse events | Overall | 15 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04667949
GET https://conductscience.org/api/trials/v1/NCT04667949/results?page=2