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38 Week Extension Study to CAIN457C2303

NCT ID: NCT01093846

Last Updated: 2016-02-22

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

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

Brief Summary

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A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy

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Detailed Description

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Conditions

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Uveitis

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 300 mg every 2 weeks

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

300mg every 2 weeks

AIN457 300 mg monthly

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

300mg every 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo AIN457

Intervention Type DRUG

Placebo to AIN457

Interventions

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AIN457

300mg every 4 weeks

Intervention Type DRUG

AIN457

300mg every 2 weeks

Intervention Type DRUG

Placebo AIN457

Placebo to AIN457

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 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

Baltimore, Maryland, United States

Site Status

Novartis Investigative Site

Alexandria, , Egypt

Site Status

Novartis Investigative Site

Grenoble, , France

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Athens, GR, Greece

Site Status

Novartis Investigative Site

Ioannina, GR, Greece

Site Status

Novartis Investigative Site

Larissa, GR, Greece

Site Status

Novartis Investigative Site

Pátrai, , Greece

Site Status

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Site Status

Novartis Investigative Site

Ramat Gan, , Israel

Site Status

Novartis Investigative Site

Tel Aviv, , Israel

Site Status

Novartis Investigative Site

Amman, , Jordan

Site Status

Novartis Investigative Site

Singapore, Singapore, Singapore

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Lin-Ko, , Taiwan

Site Status

Novartis Investigative Site

Sfax, , Tunisia

Site Status

Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, Turkey, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Altindag / Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Fatih / Istanbul, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Countries

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United States Egypt France Germany Greece Hong Kong Israel Jordan Singapore South Korea Spain Taiwan Tunisia Turkey (Türkiye)

Other Identifiers

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2009-013901-33

Identifier Type: -

Identifier Source: secondary_id

CAIN457C2303E1

Identifier Type: -

Identifier Source: org_study_id

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