Trial · NCT01705236
A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®
NCT01705236, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2020-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®. Trials, record NCT01705236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01705236
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®
- NCT number
- NCT01705236
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 87 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapsing Remitting Multiple Sclerosis RRMS
- Interventions
- Fingolimod
- First posted
- 2012-10-12
- Last updated
- 2020-03-02
- Results first posted
- 2020-03-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Baseline, month 36 | The primary endpoint was the change, i.e. the absolute difference, in average RNFL thickness from baseline to month 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT). |
| Secondary | Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Baseline, month 12, month 24 | Change from baseline in average RNFL thickness to months 12 and 24 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT). |
| Secondary | Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Baseline, month 12, month 24, month 36 | Change from baseline in average quadrant RNFL thickness to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average quadrant RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT). Quadrant RNFL thickness were: Nasal-inferior; nasal-superior; temporal-inferior; temporal-superior. |
| Secondary | Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV) | 12, 24 and 36 months | Change from baseline in TMV to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). |
| Secondary | Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP) | Baseline, month 12, month 24, month 36 | Change from baseline in GCIP to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). The change in Ganglion cell layer thickness (GCLT) had been defined as secondary endpoint in the protocol, but OCT measured the GCIP instead. This was done because both layers were not clearly separable by OCT. GCIP was calculated as mean of the inner sectors (nasal, superior, temporal, and inferior) and declared as usual parameter instead. This change was introduced prior to data base lock, but the derivation of GCIP was corrected after data base lock. |
| Secondary | Number of Participants With Adverse Events | 36 months | Number of participants with adverse events and specifically macular edema. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Baseline, month 36 | Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment. | micrometer | MEAN |
| SECONDARY | Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Baseline, month 12, month 24 | Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment. | micrometer | MEAN |
| SECONDARY | Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Baseline, month 12, month 24, month 36 | Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment. | micrometer | MEAN |
| SECONDARY | Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV) | 12, 24 and 36 months | Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment. | Cubic millimeter | MEAN |
| SECONDARY | Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP) | Baseline, month 12, month 24, month 36 | Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment. | micrometer | MEAN |
| SECONDARY | Number of Participants With Adverse Events | 36 months | Safety Population (SAF). The SAF consisted of all subjects treated with fingolimod for whom safety information had been collected. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | -1.5 | Standard Deviation 2.7 | micrometer | |
| Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Change from baseline to month 12 | -0.8 | Standard Deviation 2.4 | micrometer |
| Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Change from baseline to month 24 | -1.1 | Standard Deviation 2.4 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Nasal-superior RNFL thickness: month 12 | 0.5 | Standard Deviation 4.0 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Nasal-superior RNFL thickness: month 24 | -0.4 | Standard Deviation 3.4 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Nasal-superior RNFL thickness: month 36 | -0.7 | Standard Deviation 3.9 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Nasal-inferior RNFL thickness: month 12 | -1.2 | Standard Deviation 4.9 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Nasal-inferior RNFL thickness: month 24 | -1.6 | Standard Deviation 5.1 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Nasal-inferior RNFL thickness: month 36 | -2.1 | Standard Deviation 5.2 | micrometer |
| Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT) | Fingolimod - Longitudinal Assessment | Temporal-inferior RNFL thickness: month 12 | -1.2 | Standard Deviation 2.5 | micrometer |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod - Longitudinal Assessment | 87 | |
| Overall Study | COMPLETED | Fingolimod - Longitudinal Assessment | 60 | |
| Overall Study | NOT COMPLETED | Fingolimod - Longitudinal Assessment | 27 |
Source ClinicalTrials.gov
Adverse events35
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 | LYMPHOPENIA | Blood and lymphatic system disorders | Fingolimod - Longitudinal Assessment | 9 | 87 | |
| other | DIARRHOEA | Gastrointestinal disorders | Fingolimod - Longitudinal Assessment | 6 | 87 | |
| other | BRONCHITIS | Infections and infestations | Fingolimod - Longitudinal Assessment | 6 | 87 | |
| other | CONJUNCTIVITIS | Infections and infestations | Fingolimod - Longitudinal Assessment | 5 | 87 | |
| other | NASOPHARYNGITIS | Infections and infestations | Fingolimod - Longitudinal Assessment | 41 | 87 | |
| other | SINUSITIS | Infections and infestations | Fingolimod - Longitudinal Assessment | 6 | 87 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Fingolimod - Longitudinal Assessment | 7 | 87 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Fingolimod - Longitudinal Assessment | 7 | 87 | |
| other | VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | Fingolimod - Longitudinal Assessment | 8 | 87 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Fingolimod - Longitudinal Assessment | 5 | 87 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod - Longitudinal Assessment | 0 | 87 |
| Total, other adverse events | Fingolimod - Longitudinal Assessment | 68 | 87 |
| Total, serious adverse events | Fingolimod - Longitudinal Assessment | 11 | 87 |
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/NCT01705236
GET https://conductscience.org/api/trials/v1/NCT01705236/results?page=2