Trial · NCT00624468
Atacicept in Subjects With Optic Neuritis
NCT00624468, Phase 2, Terminated, EMD Serono; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Atacicept in Subjects With Optic Neuritis. Trials, record NCT00624468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00624468
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atacicept in Subjects With Optic Neuritis
- NCT number
- NCT00624468
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Optic Neuritis
- Interventions
- Atacicept, Placebo matched to atacicept
- First posted
- 2008-02-27
- Last updated
- 2016-02-17
- Results first posted
- 2016-02-17
- Limitations and caveats
- The Sponsor voluntarily terminated this trial after observing increased Multiple Sclerosis (MS) disease activity in trial 28063 (ATAMS).
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) | Baseline, LOV (Week 48) | The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline. |
| Secondary | Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Weeks 12, 24 and 36 | The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye. |
| Secondary | Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively. |
| Secondary | Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 | Baseline, Weeks 12, 24 and 36 | The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively. |
| Secondary | Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 | Baseline, Weeks 12, 24 and 36 | The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively. |
| Secondary | Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 | Baseline, Weeks 12, 24 and 36 | The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively. |
| Secondary | Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified | Weeks 12, 24 and 36 | Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity. |
| Secondary | Contrast Sensitivity: Total Number of Letters Correctly Identified | Weeks 12, 24 and 36 | Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity. |
| Secondary | Contrast Sensitivity: Score Line | Weeks 12, 24 and 36 | Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity). |
| Secondary | Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack | From baseline (Study Day 1) up to Week 36 | Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature \[axillary, orally or intraauricularly\] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) | Baseline, LOV (Week 48) | ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category. | micrometer | MEAN |
| SECONDARY | Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | micrometer | MEAN |
| SECONDARY | Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | micrometer | MEAN |
| SECONDARY | Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 | Baseline, Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category. | micrometer | MEAN |
| SECONDARY | Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 | Baseline, Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category. | micrometer | MEAN |
| SECONDARY | Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 | Baseline, Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category. | cubic micrometer | MEAN |
| SECONDARY | Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified | Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | letters | MEAN |
| SECONDARY | Contrast Sensitivity: Total Number of Letters Correctly Identified | Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | letters | MEAN |
| SECONDARY | Contrast Sensitivity: Score Line | Weeks 12, 24 and 36 | ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack | From baseline (Study Day 1) up to Week 36 | ITT population included all randomized participants. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) | Placebo: Double-blind Period | Baseline (n = 17, 17) | 103.893 | Standard Deviation 17.271 | micrometer |
| Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) | Atacicept: Double-blind Period | Baseline (n = 17, 17) | 104.170 | Standard Deviation 8.832 | micrometer |
| Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) | Placebo: Double-blind Period | Change at LOV (n = 16, 15) | -17.317 | Standard Deviation 15.158 | micrometer |
| Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) | Atacicept: Double-blind Period | Change at LOV (n = 16, 15) | -8.636 | Standard Deviation 10.056 | micrometer |
| Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Placebo: Double-blind Period | Change at Week 12 (n = 13, 13) | -14 | Standard Error 4 | micrometer |
| Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Atacicept: Double-blind Period | Change at Week 12 (n = 13, 13) | -7.9 | Standard Error 1.5 | micrometer |
| Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Placebo: Double-blind Period | Change at Week 24 (n = 4, 5) | -7 | Standard Error 6.9 | micrometer |
| Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Atacicept: Double-blind Period | Change at Week 24 (n = 4, 5) | -10.6 | Standard Error 3.7 | micrometer |
| Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Placebo: Double-blind Period | Change at Week 36 (n = 3, 4) | -7.5 | Standard Error 8.8 | micrometer |
| Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye | Atacicept: Double-blind Period | Change at Week 36 (n = 3, 4) | -9.4 | Standard Error 6.6 | micrometer |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Placebo: Double-blind Period | 17 | |
| Double-blind Period | STARTED | Atacicept: Double-blind Period | 17 | |
| Double-blind Period | STARTED | Placebo: SFU Period | 0 | |
| Double-blind Period | STARTED | Atacicept: SFU Period | 0 | |
| Double-blind Period | COMPLETED | Placebo: Double-blind Period | 3 | |
| Double-blind Period | COMPLETED | Atacicept: Double-blind Period | 4 | |
| Double-blind Period | COMPLETED | Placebo: SFU Period | 0 | |
| Double-blind Period | COMPLETED | Atacicept: SFU Period | 0 | |
| Double-blind Period | NOT COMPLETED | Placebo: Double-blind Period | 14 | |
| Double-blind Period | NOT COMPLETED | Atacicept: Double-blind Period | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events460
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 | Injection site reaction | General disorders | Placebo: Double-blind Period | 3 | 17 | |
| other | Injection site reaction | General disorders | Atacicept: Double-blind Period | 11 | 17 | |
| other | Injection site reaction | General disorders | Placebo: SFU Period | 1 | 13 | |
| other | Injection site reaction | General disorders | Atacicept: SFU Period | 2 | 14 | |
| other | Fatigue | General disorders | Placebo: Double-blind Period | 3 | 17 | |
| other | Fatigue | General disorders | Atacicept: Double-blind Period | 3 | 17 | |
| other | Fatigue | General disorders | Placebo: SFU Period | 0 | 13 | |
| other | Fatigue | General disorders | Atacicept: SFU Period | 0 | 14 | |
| other | Injection site haematoma | General disorders | Placebo: Double-blind Period | 1 | 17 | |
| other | Injection site haematoma | General disorders | Atacicept: Double-blind Period | 3 | 17 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo: Double-blind Period | ||
| Total, all-cause mortality | Atacicept: Double-blind Period | ||
| Total, all-cause mortality | Placebo: SFU Period | ||
| Total, all-cause mortality | Atacicept: SFU Period | ||
| Total, other adverse events | Placebo: Double-blind Period | 14 | 17 |
| Total, other adverse events | Atacicept: Double-blind Period | 16 | 17 |
| Total, other adverse events | Placebo: SFU Period | 6 | 13 |
| Total, other adverse events | Atacicept: SFU Period | 10 | 14 |
| Total, serious adverse events | Placebo: Double-blind Period | 0 | 17 |
| Total, serious adverse events | Atacicept: Double-blind Period | 0 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00624468
GET https://conductscience.org/api/trials/v1/NCT00624468/results?page=2