Phase 3
Completed N=424
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
Source: ClinicalTrials.gov NCT01148225 ↗Enrolled (actual)
424
Serious AEs
23.8%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 398; 101 participants
◆ Published Evidence
Established
58citations · ~12 / year
Long-Term Safety and Efficacy of Adalimumab in Patients with Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis.
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.
Linked Publications
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Long-Term Safety and Efficacy of Adalimumab in Patients with Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.