Clinical trial NCT01093846: 38 Week Extension Study to CAIN457C2303
Official title: A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy (SHIELD Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uveitis
Keywords: uveitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.
timeFrame: 62 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Alexandria
country: Egypt
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Ioannina
country: Greece
facility: Novartis Investigative Site
state: GR
city: Larissa
country: Greece
facility: Novartis Investigative Site
state: GR
city: Patras
country: Greece
facility: Novartis Investigative Site
city: Hongkong
country: Hong Kong
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Singapore
country: Singapore
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: Lin-Ko
country: Taiwan
facility: Novartis Investigative Site
city: Sfax
country: Tunisia
facility: Novartis Investigative Site
city: Altindag / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Fatih / Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: