Clinical trial NCT01090310: Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-infectious Uveitis
Keywords: Quiescent uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis
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Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression


Eligibility criteria: Inclusion Criteria:

* Patients who have completed the entire treatment period of the 24 week core 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 wouldpreclude the participant from adhering to the protocol or completing the study per protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
timeFrame: Baseline to 52 weeks
Secondary outcomes:
measure: Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value
timeFrame: Baseline to 52 weeks
measure: Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension
timeFrame: Baseline to 52 weeks
measure: Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies
timeFrame: Baseline to 52 weeks
measure: Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension
timeFrame: Baseline to 52 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Cambridge
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Teaneck
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
state: CHE
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Luzern
country: Switzerland
facility: Novartis Investigative Site
city: St. Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: York
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: