Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis (SUPPORT)

This study has been withdrawn prior to enrollment.
(Study will not be initiated as planned.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01327664
First received: February 24, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.


Condition Intervention Phase
Uveitis
Biological: AIN457
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Mean time to achieve the criteria for clinically inactive posterior segment uveitis [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 300mg s.c every 2 weeks Biological: AIN457

  Eligibility

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

Inclusion Criteria:

  • 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 any study assessment is performed
  • Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1)
  • Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator

Exclusion Criteria:

  • Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457
  • Pregnant or nursing (lactating) women
  • Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation

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: NCT01327664

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01327664     History of Changes
Other Study ID Numbers: CAIN457C2399, 2010-021239-15
Study First Received: February 24, 2011
Last Updated: December 5, 2013
Health Authority: 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
Turkey: IEGM (The General Directorate of Pharmaceuticals and Pharmacy)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitaria)
India: Drugs Controller General of India
Israel: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Novartis:
Quiescent 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 21, 2014