Uveitis
Conditions
Keywords
Active uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
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.
Interventions
BIOLOGICALAIN457
BIOLOGICALPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of recurrence | baseline to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in immunosuppressive medication score from core study baseline | baseline to 52 weeks |
| 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 | baseline to 52 weeks |
| Mean change in best corrected visual acuity from baseline | baseline to 52 weeks |
| Change from baseline in Quality of Life/Patient reported outcome assessments | baseline to 52 weeks |
| Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks | baseline to 52 weeks |
Countries
Canada, Israel, Japan, Switzerland, United States
Outcome results
None listed