Optic NeuritisPhase 2NCT00624468
Atacicept in Subjects With Optic Neuritis
A Phase 2 study testing Atacicept in people with Optic Neuritis, run by EMD Serono at 28 sites in 11 countries.
Trial summary
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Atacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 28 sitesin 11 countries
- Study dates
- Jun 2008to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1
- Other protocol defined inclusion criteria could apply
Who cannot join
- Pre treatment with immunosuppressants and immunomodulating drugs
- Relevant cardiac, hepatic and renal diseases
- Clinical significant abnormalities in blood cell counts and immunoglobulin levels
- Clinical significant acute or chronic infections
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
28 sites in 11 countries.
28 sites in 11 countries
United States8 sites
Research Site
Aurora, Colorado
Research Site
Birmingham, Alabama
Research Site
Burlington, Vermont
Research Site
East Lansing, Michigan
Research Site
Fairfield, Connecticut
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Philadelphia, Pennsylvania
Germany4 sites
Research Site
Freiburg im Breisgau
Research Site
Munich
Research Site
Tübingen
Research Site
Würzburg
Canada3 sites
Research Site
Montreal, Quebec
Research Site
Ottawa, Ontario
Research Site
Vancouver, British Columbia
About this study
Official title: A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.
- Conditions
- Optic Neuritis
- Being tested
- Atacicept, Placebo matched to atacicept
- Keywords
- atacicept, neuritis
- Medical subject headings
- Optic Neuritis, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciceptDrug
Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Placebo matched to ataciceptDrug
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Atacicept | Experimental | Not described Receives: Drug: Atacicept |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matched to atacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)
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.
Measured: Baseline, LOV (Week 48)
Secondary outcomes (9)
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye
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.
Measured: Weeks 12, 24 and 36
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at 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.
Measured: Baseline, Weeks 12 and 24
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at 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.
Measured: Baseline, Weeks 12, 24 and 36
Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at 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.
Measured: Baseline, Weeks 12, 24 and 36
Change From Baseline in Macular Volume in the Affected Eye at 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.
Measured: Baseline, Weeks 12, 24 and 36
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified
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.
Measured: Weeks 12, 24 and 36
Contrast Sensitivity: Total Number of Letters Correctly Identified
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.
Measured: Weeks 12, 24 and 36
Contrast Sensitivity: Score Line
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).
Measured: Weeks 12, 24 and 36
Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack
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.
Measured: From baseline (Study Day 1) up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionJan 2011
Why it stopped: EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS \[Please refer to ATAMS\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624468
- Sponsor's protocol ID
- 28156
- Status last verified
- Jan 2016
- First submitted
- 15 Feb 2008
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course
- ClinicalTrials.gov ID
- NCT00624468
- Acronym / sponsor ID
- 28156
- Conditions
- Optic Neuritis
- Keywords
- atacicept, neuritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS \[Please refer to ATAMS\]
- Enrolment
- 34 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atacicept | Experimental | Drug: Atacicept |
| Placebo | Placebo comparator | Drug: Placebo matched to atacicept |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (5 listed)
- Pre treatment with immunosuppressants and immunomodulating drugs
- Relevant cardiac, hepatic and renal diseases
- Clinical significant abnormalities in blood cell counts and immunoglobulin levels
- Clinical significant acute or chronic infections
- Other protocol defined exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtaciceptAtacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. | Drug | Atacicept |
| Placebo matched to ataciceptPlacebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)
Time frame: 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.
9 secondary outcomes
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye
Time frame: Weeks 12, 24 and 36
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36
Time frame: Baseline, Weeks 12, 24 and 36
Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36
Time frame: Baseline, Weeks 12, 24 and 36
Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36
Time frame: Baseline, Weeks 12, 24 and 36
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified
Time frame: Weeks 12, 24 and 36
Contrast Sensitivity: Total Number of Letters Correctly Identified
Time frame: Weeks 12, 24 and 36
Contrast Sensitivity: Score Line
Time frame: Weeks 12, 24 and 36
Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack
Time frame: From baseline (Study Day 1) up to Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
28 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atacicept in people with Optic Neuritis, run by EMD Serono at 28 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Germany, Canada, Spain, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) (time frame: Baseline, LOV (Week 48)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.