Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

NCT ID: NCT01090310

Last Updated: 2016-01-14

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-07-31

Brief Summary

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This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Detailed Description

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Conditions

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Non-infectious Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AIN457 300mg every 2 weeks

AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake

AIN457 300 mg every 4 weeks

AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake

AIN457 150 mg every 4 weeks

AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake

Placebo

Placebo s.c. every 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to AIN457

Interventions

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AIN457

AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake

Intervention Type DRUG

Placebo

Matching placebo to AIN457

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have completed the entire treatment period of the 24 week core study

Exclusion Criteria

* Inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol.
Minimum Eligible Age

18 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

Beverly Hills, California, United States

Site Status

Novartis Investigative Site

Atlanta, Georgia, United States

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Novartis Investigative Site

Louisville, Kentucky, United States

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Novartis Investigative Site

Baltimore, Maryland, United States

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Novartis Investigative Site

Cambridge, Massachusetts, United States

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Novartis Investigative Site

Teaneck, New Jersey, United States

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Novartis Investigative Site

Charlotte, North Carolina, United States

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Novartis Investigative Site

Portland, Oregon, United States

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Novartis Investigative Site

Arlington, Texas, United States

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Novartis Investigative Site

Houston, Texas, United States

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Novartis Investigative Site

São Paulo, São Paulo, Brazil

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Novartis Investigative Site

São Paulo, São Paulo, Brazil

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Kiel, , Germany

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Novartis Investigative Site

Tübingen, , Germany

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Novartis Investigative Site

New Delhi, , India

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Novartis Investigative Site

Jerusalem, , Israel

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Novartis Investigative Site

Petah Tikva, , Israel

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Novartis Investigative Site

Ramat Gan, , Israel

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Novartis Investigative Site

Tel Aviv, , Israel

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Novartis Investigative Site

Barcelona, Catalonia, Spain

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Novartis Investigative Site

Barcelona, Catalonia, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, Spain

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Novartis Investigative Site

Madrid, Madrid, Spain

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Novartis Investigative Site

Lausanne, CHE, Switzerland

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Novartis Investigative Site

Lausanne, Switzerland, Switzerland

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Novartis Investigative Site

Bern, , Switzerland

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Novartis Investigative Site

Bern, , Switzerland

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Novartis Investigative Site

Lucerne, , Switzerland

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Novartis Investigative Site

Sankt Gallen, , Switzerland

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Novartis Investigative Site

Zurich, , Switzerland

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Novartis Investigative Site

Birmingham, , United Kingdom

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Novartis Investigative Site

Liverpool, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

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Novartis Investigative Site

York, , United Kingdom

Site Status

Countries

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United States Brazil Germany India Israel Spain Switzerland United Kingdom

Other Identifiers

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2009-015508-24

Identifier Type: -

Identifier Source: secondary_id

CAIN457C2301E1

Identifier Type: -

Identifier Source: org_study_id

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