Atacicept in Subjects With Optic Neuritis

NCT ID: NCT00624468

Last Updated: 2016-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Optic Neuritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atacicept

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo matched to atacicept

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role collaborator

EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

Locations

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Research Site

Birmingham, Alabama, United States

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Aurora, Colorado, United States

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Fairfield, Connecticut, United States

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Jacksonville, Florida, United States

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East Lansing, Michigan, United States

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Philadelphia, Pennsylvania, United States

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Houston, Texas, United States

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Burlington, Vermont, United States

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Parkville, Victoria, Australia

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Brussels, , Belgium

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Paris, , France

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Freiburg im Breisgau, , Germany

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Munich, , Germany

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Tübingen, , Germany

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Würzburg, , Germany

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Beirut, , Lebanon

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Dbaïyé, , Lebanon

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Barcelona, , Spain

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Seville, , Spain

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Valencia, , Spain

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Lausanne, , Switzerland

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London, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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United States Australia Belgium Canada Czechia France Germany Lebanon Spain Switzerland United Kingdom

Other Identifiers

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28156

Identifier Type: -

Identifier Source: org_study_id

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