Phase 3
N=424
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT01148225 ↗Enrolled (actual)
424
Serious AEs
23.8%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Adverse Events — 398; 101 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
398; 101 | — |
| PRIMARY Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values |
3; 6; 7 | — |
| PRIMARY Chemistry: Number of Participants With PCS Values |
2; 3; 1; 2; 5; 4 | — |
| PRIMARY Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit |
-1.0 | — |
| PRIMARY Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit |
-0.1 | — |
| PRIMARY Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit |
-0.03 | — |
| PRIMARY Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit |
1.443; 1.955 | — |
| SECONDARY Percentage of Participants in Quiescence Over Time |
33.5; 56.3; 63.8; 72.0; 72.4; 75.2 | — |
| SECONDARY Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start |
38.7 | — |
| SECONDARY Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start |
67.7 | — |
| SECONDARY Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time |
11.8; 8.4; 7.6; 6.9; 3.6; 5.3 | — |
| SECONDARY Percentage of Participants With Steroid-free Quiescence Over Time |
30.5; 34.8; 35.6; 41.4; 44.4; 47.6 | — |
| SECONDARY Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start |
10.5; 2.4; 13.7; 8.9; 3.2; 0.8 | — |
| SECONDARY Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start |
19.2; 10.8; 15.0; 15.4; 6.7; 0.4 | — |
| SECONDARY Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study |
20.3 | — |
| SECONDARY Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time |
13.6; 14.8; 10.1; 7.3; 6.0; 5.1 | — |
| SECONDARY Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time |
1.5; 1.6; 1.4; 0.9; 0.9; 0.8 | — |
| SECONDARY Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time |
-11.8; -46.6; -64.5; -29.7; -30.8; -25.0 | — |
| SECONDARY Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time |
-4.6; -25.0; -41.7; -46.3; -55.1; -62.8 | — |
| SECONDARY Percentage of Participants Not Using Systemic Corticosteroids Over Time |
66.3; 58.7; 60.2; 61.9; 64.7; 68.3 | — |
| SECONDARY Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry |
100; 99.1; 100; 100; 100; 99.1 | — |
| SECONDARY Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry |
96.8; 96.3; 96.6; 94.9; 94.7; 93.3 | — |
| SECONDARY Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time |
0.20; 0.17; 0.15; 0.14; 0.13; 0.12 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01148225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.