NCT01148225

A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long term efficacy and safety of adalimumab participants with non-infectious intermediate-, posterior- or pan-uveitis.

Detailed description

This study was initially planned to run for 78 weeks but was extended for ethical reasons, to avoid leaving participants untreated who had responded well to adalimumab treatment, so that participants were allowed to remain in the study until regulatory and/or reimbursement approval for the treatment of uveitis in adults was obtained for their respective countries. Data were collected through Week 366 (maximum), but because of decreasing sample size that became too small toward the end of the study to allow for meaningful conclusion, data cut off for efficacy analyses (intent to treat \[ITT\] population) occurred at Week 246, as less than 10% of participants in the ITT set had visits beyond this timepoint.

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	adalimumab	Adalimumab, pre-filled syringe, administered by SC injection

Timeline

• Start date: 2010-11-23
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2010-06-22
• Last updated: 2021-07-12
• Results posted: 2019-04-04

Regulatory

• FDA-regulated drug study