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This study has been withdrawn prior to enrollment.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
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 April 17, 2014