Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis (INSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103024
Recruitment Status : Terminated (Core study in non-infectious active uveitis was terminated. Patients came only for the planned safety follow-up visit in this extension study.)
First Posted : April 13, 2010
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of the extension study is to provide patients completing the 28-week core study with an opportunity to receive an additional 22 weeks of continuous treatment.

Condition or disease Intervention/treatment Phase
Uveitis Biological: AIN457 Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 34-week Extension to a 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior, or Panuveitis Requiring Immunosuppression (INSURE Study)
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: AIN457 300mg s.c every 2 weeks Biological: AIN457
Experimental: AIN457 300mg s.c every 4 weeks Biological: AIN457
Experimental: AIN457 150mg s.c every 4 weeks Biological: AIN457
Placebo Comparator: Placebo s.c every 2 weeks Biological: Placebo

Primary Outcome Measures :
  1. Rate of recurrence [ Time Frame: baseline to 52 weeks ]

Secondary Outcome Measures :
  1. Change in immunosuppressive medication score from core study baseline [ Time Frame: baseline to 52 weeks ]
  2. Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication [ Time Frame: baseline to 52 weeks ]
  3. Mean change in best corrected visual acuity from baseline [ Time Frame: baseline to 52 weeks ]
  4. Change from baseline in Quality of Life/Patient reported outcome assessments [ Time Frame: baseline to 52 weeks ]
  5. Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks [ Time Frame: baseline to 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have completed the entire treatment period of the 28-week core study
  • Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before study treatment in the extension 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 would preclude the participant from adhering to the protocol or completing the study per protocol
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
  • Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS
  • They are using simultaneously double barrier or two acceptable methods of contraception
  • They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing
  • They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing
  • Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
  • Partners have been sterilized by vasectomy or other reliable means

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103024

United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
North York, Ontario, Canada
Novartis Investigative Site
Ramat Gan, Israel, 52621
Novartis Investigative Site
Bunkyo-ku, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Fukushima, Japan
Novartis Investigational Site
Kyoto, Japan, 602-0841
Novartis Investigative Site
Sapporo, Japan
Novartis Investigative Site
Tochigi, Japan
Novartis Investigative Site
Bern, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Identifier: NCT01103024     History of Changes
Other Study ID Numbers: CAIN457C2302E1
2009-015509-38 ( EudraCT Number )
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis:
Active uveitis
intermediate uveitis
posterior uveitis

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases