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:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01103024
First received: April 9, 2010
Last updated: May 2, 2012
Last verified: May 2012
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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) |
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
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 June 18, 2013