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

This study has been terminated.
(Core study in non-infectious active uveitis was terminated. Patients came only for the planned safety follow-up visit in this extension study.)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01103024
First received: April 9, 2010
Last updated: May 2, 2012
Last verified: May 2012

April 9, 2010
May 2, 2012
December 2010
February 2011   (final data collection date for primary outcome measure)
Rate of recurrence [ Time Frame: baseline to 52 weeks ] [ Designated as safety issue: No ]
Rate of recurrence [ Time Frame: after baseline ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01103024 on ClinicalTrials.gov Archive Site
  • Change in immunosuppressive medication score from core study baseline [ Time Frame: baseline to 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean change in best corrected visual acuity from baseline [ Time Frame: baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life/Patient reported outcome assessments [ Time Frame: baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks [ Time Frame: baseline to 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Uveitis
  • Biological: AIN457
  • Biological: Placebo
  • Experimental: AIN457 300mg s.c every 2 weeks
    Intervention: Biological: AIN457
  • Experimental: AIN457 300mg s.c every 4 weeks
    Intervention: Biological: AIN457
  • Experimental: AIN457 150mg s.c every 4 weeks
    Intervention: Biological: AIN457
  • Placebo Comparator: Placebo s.c every 2 weeks
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
February 2011
February 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Canada,   Israel,   Switzerland,   United States
 
NCT01103024
CAIN457C2302E1, 2009-015509-38
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP