A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Poster… (NCT01148225) | Clinical Trial Compass
CompletedPhase 3
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
424 participantsStarted 2010-11-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Baseline to Final Visit (up to 366 weeks)
2
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values
Timeframe: Baseline to Final Visit (Up to 366 weeks)
3
Chemistry: Number of Participants With PCS Values
Timeframe: Baseline to Final Visit (Up to 366 weeks)
4
Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit
Timeframe: Baseline to Final Visit (Up to 366 weeks)
5
Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit
Timeframe: Baseline to Final Visit (Up to 366 weeks)
6
Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit
Timeframe: Baseline to Final Visit (Up to 366 weeks)
7
Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit