Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis Study (ENDURE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01090310
First received: March 18, 2010
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

The extension study will serve to provide patients completing the 24 week core study with an opportunity to receive additional 26 weeks of continuous treatment. It will also provide 12-week treatment-free safety follow up for patients who will not receive continuous treatment in extension.


Condition Intervention Phase
Non-infectious Uveitis
Biological: AIN457
Drug: 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 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis (ENDURE Study)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Recurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters [ Time Frame: after baseline of CORE study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in immunosuppressive medication score from baseline to 52 weeks [ 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 ]
  • Mean time to recurrence of active intermediate, posterior, or panuveitis 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: 70
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo s.c every 2 weeks Drug: Placebo
Experimental: AIN457 150mg s.c every 4 weeks Biological: AIN457
Experimental: AIN457 300mg s.c every 2 weeks Biological: AIN457
Experimental: AIN457 300mg s.c every 4 weeks Biological: AIN457

  Eligibility

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

Inclusion Criteria:

Group 1: Active treatment

  • Patients who have completed the entire treatment period of 24 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 written, signed and dated informed consent before starting treatment in the extension study.

Group 2: Patients in follow-up who will not receive drug in extension study

  • Patients who were randomized into the 24-week core study and did not complete the treatment period or will not continue treatment in the extension phase.

Exclusion Criteria:

Group 1:

  • 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.

No Exclusion criteria for Group 2.

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: NCT01090310

  Show 64 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01090310     History of Changes
Other Study ID Numbers: CAIN457C2301E1, 2009-015508-24
Study First Received: March 18, 2010
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Health Surveillance Agency
India: Ministry of Health
Israel: Ministry of Health

Keywords provided by Novartis:
Quiescent uveitis
Intermediate uveitis
Panuveitis
Posterior uveitis
Uveitis

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

ClinicalTrials.gov processed this record on October 30, 2014