Status:
COMPLETED
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
Lead Sponsor:
AbbVie
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Participant must have successfully enrolled in either study M10-877 or M10-880 and either met the endpoint of "Treatment Failure" or completed the study
Exclusion
- A participant will be excluded from this study if the participant discontinued from study M10-877 or M10-880 for any reasons other than having a Treatment Failure event
- Participant with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
- Participants with intraocular pressure of \>= 25 mmHg and on \>= 2 glaucoma medications or evidence of glaucomatous optic nerve injury
- Participant with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
- Participant with neovascular/wet age-related macular degeneration
- Participant with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
- Participant with a systemic inflammatory disease that requires therapy with a prohibited immunosuppressive agent at the time of study entry
Key Trial Info
Start Date :
November 23 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2018
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT01148225
Start Date
November 23 2010
End Date
May 21 2018
Last Update
July 12 2021
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