Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (Visual II)
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|ClinicalTrials.gov Identifier: NCT01124838|
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : June 21, 2016
Last Update Posted : August 11, 2016
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
|Recruitment Details||This study includes a Japan sub-study. A total of 261 adults with inactive non-infectious intermediate uveitis, posterior uveitis or panuveitis were randomized at 72 study sites worldwide; 229 participants at 62 study sites in Australia, Israel, Latin America, North America, and Europe (Main Study), and 32 participants at 10 study sites in Japan.|
Participants were randomized in a 1:1 ratio double-masked fashion using baseline immunosuppressant (IMM) usage as the stratification factor. Participants in the Japan sub-study were randomized in a separate stratum with no stratification by baseline IMM usage.
Study completion is defined as meeting treatment failure or reaching study Week 80.