Clinical trial NCT01103024: Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
Official title: A 34-week Extension to a 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior, or Panuveitis Requiring Immunosuppression (INSURE Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Uveitis
Keywords: Active uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 0
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: The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed the entire treatment period of the 28-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 a written, signed, and dated informed consent before study treatment in the extension 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 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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Rate of recurrence
timeFrame: baseline to 52 weeks
Secondary outcomes:
measure: Change in immunosuppressive medication score from core study baseline
timeFrame: baseline to 52 weeks
measure: Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication
timeFrame: baseline to 52 weeks
measure: Mean change in best corrected visual acuity from baseline
timeFrame: baseline to 52 weeks
measure: Change from baseline in Quality of Life/Patient reported outcome assessments
timeFrame: baseline to 52 weeks
measure: Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks
timeFrame: baseline to 52 weeks
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: North York
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukushima
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigational Site
city: Sapporo
country: Japan
facility: Novartis Investigative Site
city: Tochigi
country: Japan
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: