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POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler

NCT ID: NCT01051817

Last Updated: 2015-02-27

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-04-30

Brief Summary

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A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis

Detailed Description

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Conditions

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Relapsing-remitting Multiple Sclerosis RRMS

Keywords

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relapsing-remitting multiple sclerosis RRMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIN457

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

infusion 10 mg/Kg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

infusion

Interventions

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AIN457

infusion 10 mg/Kg

Intervention Type DRUG

Placebo

infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Hradec Králové, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Ostrava, , Czechia

Site Status

Novartis Investigative Site

Ostrava-Moravska Ostrava, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Teplice, , Czechia

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Nizhny Novgorod, , Russia

Site Status

Novartis Investigative Site

Smolensk, , Russia

Site Status

Novartis Investigative Site

Kharkiv, , Ukraine

Site Status

Novartis Investigative Site

Kharkiv, , Ukraine

Site Status

Novartis Investigative Site

Kiev, , Ukraine

Site Status

Novartis Investigative Site

Kiev, , Ukraine

Site Status

Novartis Investigative Site

Odesa, , Ukraine

Site Status

Novartis Investigative Site

Vinnitsya, , Ukraine

Site Status

Countries

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Serbia Sweden Czechia Russia Ukraine

Other Identifiers

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2009-011626-34

Identifier Type: -

Identifier Source: secondary_id

CAIN457B2201

Identifier Type: -

Identifier Source: org_study_id