Atacicept in Subjects With Optic Neuritis

Optic Neuritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00624468
• Other study ID #: 28156
• Status: Terminated
• Phase: Phase 2
• First received: February 15, 2008
• Last updated: January 19, 2016
• Start date: June 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2016
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: January 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Drug:
• Atacicept
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 atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.

Locations

Country	Name	City	State
Australia	Research Site	Parkville	Victoria
Belgium	Research Site	Bruxelles
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Vancouver	British Columbia
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
France	Research Site	Paris
Germany	Research Site	Freiburg
Germany	Research Site	Munich
Germany	Research Site	Tübingen
Germany	Research Site	Würzburg
Lebanon	Research Site	Beyrouth
Lebanon	Research Site	Dbayeh
Spain	Research Site	Barcelona
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Switzerland	Research Site	Lausanne
United Kingdom	Research Site	London
United Kingdom	Research Site	Sheffield
United States	Research Site	Aurora	Colorado
United States	Research Site	Birmingham	Alabama
United States	Research Site	Burlington	Vermont
United States	Research Site	East Lansing	Michigan
United States	Research Site	Fairfield	Connecticut
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono	Merck KGaA

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Lebanon,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, LOV (Week 48)	No
Secondary	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.	Weeks 12, 24 and 36	No
Secondary	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.	Baseline, Weeks 12 and 24	No
Secondary	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.	Baseline, Weeks 12, 24 and 36	No
Secondary	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.	Baseline, Weeks 12, 24 and 36	No
Secondary	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.	Baseline, Weeks 12, 24 and 36	No
Secondary	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.	Weeks 12, 24 and 36	No
Secondary	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.	Weeks 12, 24 and 36	No
Secondary	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).	Weeks 12, 24 and 36	No
Secondary	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.	From baseline (Study Day 1) up to Week 36	No