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
  Purpose

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 Intervention Phase
Uveitis
Biological: AIN457
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of recurrence [ Time Frame: baseline to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103024

Locations
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
Israel
Novartis Investigative Site
Ramat Gan, Israel, 52621
Japan
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
Switzerland
Novartis Investigative Site
Bern, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01103024     History of Changes
Other Study ID Numbers: CAIN457C2302E1, 2009-015509-38
Study First Received: April 9, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Canada: Health Canada
Egypt: Ministry of Health and Population
Japan: Ministry of Health, Labor and Welfare
Singapore: Department of Health 3/F, Public Health Laboratory Centre
Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines
Italy: Comitato Etico per la Sperimentazione Clinica dei Medicinali Dell'Azienda Ospedaliero -Universitaria Careggi di Firenze
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Ministry of Health
Israel: Ministry of Health

Keywords provided by Novartis:
Active uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on August 28, 2014