38 Week Extension Study to CAIN457C2303 - Clinical Trial for Uveitis | NCT01093846

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AIN457

Placebo AIN457

About this trial

This is an interventional treatment trial for Uveitis focused on measuring uveitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-

Exclusion Criteria:

-

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457 300 mg every 2 weeks

AIN457 300 mg monthly

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.

The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .

Secondary Outcome Measures

Full Information

NCT ID

NCT01093846

First Posted

March 24, 2010

Last Updated

January 22, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01093846

Brief Title

38 Week Extension Study to CAIN457C2303

Acronym

SHIELD

Official Title

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 (SHIELD Study)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

Core Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint

Study Start Date

March 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis

Keywords

uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 300 mg every 2 weeks

Arm Type

Experimental

Arm Title

AIN457 300 mg monthly

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

AIN457

Intervention Description

300mg every 4 weeks

Intervention Type

Drug

Intervention Name(s)

AIN457

Intervention Description

300mg every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo AIN457

Intervention Description

Placebo to AIN457

Primary Outcome Measure Information:

Title

The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.

Description

The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .

Time Frame

62 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: - Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205-2005

Country

United States

Facility Name

Novartis Investigative Site

City

Alexandria

Country

Egypt

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

GR

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Ioannina

State/Province

GR

ZIP/Postal Code

455 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

GR

ZIP/Postal Code

41110

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

Novartis Investigative Site

City

Hongkong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Amman

ZIP/Postal Code

11195

Country

Jordan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

110 744

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08028

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Lin-Ko

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Sfax

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Altindag / Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Novartis Investigative Site

City

Fatih / Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35380

Country

Turkey

38 Week Extension Study to CAIN457C2303 (SHIELD)

Uveitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial