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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01148225
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Uveitis
Intervention Drug: adalimumab
Enrollment 424
Recruitment Details  
Pre-assignment Details A total of 424 participants were enrolled and received ≥1 dose of study drug (Safety population); 364 participants were included in the intent-to-treat (ITT) population (reasons for exclusion: incomplete efficacy data or GCP compliance issues at 2 sites (n=7); diabetic retinopathy [n=1]; cataract surgery [n=26]; and previous vitrectomy [n=26]).
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Period Title: Overall Study
Started 424
Completed 239
Not Completed 185
Reason Not Completed
Other             185
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Baseline Participants 424
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 424 participants
43.44  (14.066)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 424 participants
Female 249
Male 175
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 424 participants
Hispanic or Latino 77
Not Hispanic or Latino 347
Unknown or Not Reported 0
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.
Time Frame Baseline to Final Visit (up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: includes all participants who received at least one dose of study medication.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Measure Type: Number
Unit of Measure: participants
Any TEAE 398
Any TESAE 101
2.Primary Outcome
Title Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values
Hide Description PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations used include g=grams; L=liters.
Time Frame Baseline to Final Visit (Up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Measure Type: Number
Unit of Measure: participants
Hemoglobin (Low: <80-65 g/L) 3
Neutrophils (Low: <1.0-0.5*10^9/L) 6
Lymphocytes (Low: <0.5-0.2*10^9/L) 7
3.Primary Outcome
Title Chemistry: Number of Participants With PCS Values
Hide Description PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase; AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase; g/L=grams/liter; mmol/L=millimoles/liter; ULN=upper limit of normal.
Time Frame Baseline to Final Visit (Up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Measure Type: Number
Unit of Measure: participants
ALT/SGPT (High: >5.0-20.0*ULN) 2
AST/SGOT (High: >5.0-20.0*ULN) 3
Bilirubin, Total (High: >3.0-10.0*ULN) 1
Creatinine (High: >3.0-6.0*ULN) 2
Phosphate Inorganic (Low:<0.6-0.3 mmol/L) 5
Sodium (Low: <130-120 mmol/L) 4
Potassium (Low:<3.0-2.5 mmol/L) 7
Glucose (High: >13.9-27.8 mmol/L) 18
Albumin (Low: <20.0 g/L) 2
Cholesterol (High: >10.34-12.92 mmol/L) 3
Triglycerides (High: >5.0-10*ULN) 8
4.Primary Outcome
Title Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit
Hide Description Heart rate (beats per minute) was measured while the participant was sitting.
Time Frame Baseline to Final Visit (Up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.0  (11.92)
5.Primary Outcome
Title Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit
Hide Description Respiratory rate (respirations per minute) was measured while the participant was sitting.
Time Frame Baseline to Final Visit (Up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Mean (Standard Deviation)
Unit of Measure: respirations per minute
-0.1  (2.94)
6.Primary Outcome
Title Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit
Hide Description Temperature was measured while the participant was sitting.
Time Frame Baseline to Final Visit (Up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Mean (Standard Deviation)
Unit of Measure: Centigrade
-0.03  (0.516)
7.Primary Outcome
Title Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit
Hide Description Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
Time Frame Baseline to Final Visit (Up to 366 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 424
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic Blood Pressure (Sitting) 1.443  (10.4373)
Systolic Blood Pressure (Sitting) 1.955  (14.6281)
8.Secondary Outcome
Title Percentage of Participants in Quiescence Over Time
Hide Description Quiescence is defined as no active inflammatory lesions and anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤0.5+. Participants with active uveitis at study entry could have been in quiescence at Week 0 because all participants were evaluated for uveitis status at the Final/Early Termination visit of the lead-in study and the Week 0 visit could have occurred up to 28 days later during which time the participant's disease status may have changed.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: includes all participants who received at least one dose of study medication with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 0 Number Analyzed 364 participants
33.5
(28.7 to 38.6)
Week 2 Number Analyzed 348 participants
56.3
(50.9 to 61.6)
Week 4 Number Analyzed 323 participants
63.8
(58.3 to 69.0)
Week 8 Number Analyzed 343 participants
72.0
(66.9 to 76.7)
Week 12 Number Analyzed 333 participants
72.4
(67.2 to 77.1)
Week 18 Number Analyzed 330 participants
75.2
(70.1 to 79.7)
Week 30 Number Analyzed 319 participants
79.9
(75.1 to 84.2)
Week 42 Number Analyzed 310 participants
81.3
(76.5 to 85.5)
Week 54 Number Analyzed 296 participants
81.1
(76.1 to 85.4)
Week 66 Number Analyzed 284 participants
85.9
(81.3 to 89.7)
Week 78 Number Analyzed 271 participants
86.3
(81.7 to 90.2)
Week 90 Number Analyzed 261 participants
87.4
(82.7 to 91.1)
Week 102 Number Analyzed 245 participants
87.3
(82.5 to 91.2)
Week 114 Number Analyzed 231 participants
87.9
(83.0 to 91.8)
Week 126 Number Analyzed 215 participants
88.4
(83.3 to 92.3)
Week 138 Number Analyzed 196 participants
89.3
(84.1 to 93.2)
Week 150 Number Analyzed 180 participants
85.0
(78.9 to 89.9)
Week 162 Number Analyzed 154 participants
87.0
(80.7 to 91.9)
Week 174 Number Analyzed 142 participants
87.3
(80.7 to 92.3)
Week 186 Number Analyzed 128 participants
90.6
(84.2 to 95.1)
Week 198 Number Analyzed 113 participants
89.4
(82.2 to 94.4)
Week 210 Number Analyzed 88 participants
88.6
(80.1 to 94.4)
Week 222 Number Analyzed 70 participants
92.9
(84.1 to 97.6)
Week 234 Number Analyzed 51 participants
96.1
(86.5 to 99.5)
Week 246 Number Analyzed 42 participants
95.2
(83.8 to 99.4)
9.Secondary Outcome
Title Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start
Hide Description Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
Time Frame 366 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with inactive uveitis with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.7
(30.1 to 47.9)
10.Secondary Outcome
Title Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start
Hide Description Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
Time Frame Weeks 8 to 246 (238 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with active uveitis at study start with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 232
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.7
(61.2 to 73.6)
11.Secondary Outcome
Title 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
Hide Description Dilated indirect ophthalmoscopy is performed to determine both vitreous haze grading and the absence/presence of inflammatory chorioretinal and/or inflammatory retinal vascular lesions. The number of AC cells observed within a 1 mm * 1 mm slit beam was recorded for each eye and this number was used to determine the grade according to Standardization of Uveitis Nomenclature (SUN) criteria. Grading of VH was based on the National Eye Institute (NEI) publication which was adapted by the SUN working group. The percentage of participants with new active inflammatory lesions or grade ≥2 in AC cells or grade ≥2 in VH are presented.
Time Frame Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at a given time point.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 348 participants
11.8
(8.6 to 15.6)
Week 4 Number Analyzed 323 participants
8.4
(5.6 to 11.9)
Week 8 Number Analyzed 343 participants
7.6
(5.0 to 10.9)
Week 12 Number Analyzed 333 participants
6.9
(4.4 to 10.2)
Week 18 Number Analyzed 330 participants
3.6
(1.9 to 6.3)
Week 30 Number Analyzed 319 participants
5.3
(3.1 to 8.4)
Week 42 Number Analyzed 310 participants
4.2
(2.3 to 7.1)
Week 54 Number Analyzed 296 participants
4.1
(2.1 to 7.0)
Week 66 Number Analyzed 284 participants
1.4
(0.4 to 3.6)
Week 78 Number Analyzed 271 participants
4.1
(2.0 to 7.1)
Week 90 Number Analyzed 261 participants
4.6
(2.4 to 7.9)
Week 102 Number Analyzed 245 participants
4.1
(2.0 to 7.4)
Week 114 Number Analyzed 231 participants
4.8
(2.4 to 8.4)
Week 126 Number Analyzed 215 participants
3.3
(1.3 to 6.6)
Week 138 Number Analyzed 196 participants
2.0
(0.6 to 5.1)
Week 150 Number Analyzed 180 participants
4.4
(1.9 to 8.6)
Week 162 Number Analyzed 154 participants
3.2
(1.1 to 7.4)
Week 174 Number Analyzed 142 participants
1.4
(0.2 to 5.0)
Week 186 Number Analyzed 128 participants
1.6
(0.2 to 5.5)
Week 198 Number Analyzed 113 participants
0
(0 to 0)
Week 210 Number Analyzed 88 participants
3.4
(0.7 to 9.6)
Week 222 Number Analyzed 70 participants
1.4
(0 to 7.7)
Week 234 Number Analyzed 51 participants
0
(0 to 0)
Week 246 Number Analyzed 42 participants
0
(0 to 0)
12.Secondary Outcome
Title Percentage of Participants With Steroid-free Quiescence Over Time
Hide Description Steroid-free quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+ and no uveitis-related corticosteroids on the day of assessment.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set in steroid-free quiescence with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 0 Number Analyzed 364 participants
30.5
(25.8 to 35.5)
Week 2 Number Analyzed 348 participants
34.8
(29.8 to 40.0)
Week 4 Number Analyzed 323 participants
35.6
(30.4 to 41.1)
Week 8 Number Analyzed 343 participants
41.4
(36.1 to 46.8)
Week 12 Number Analyzed 333 participants
44.4
(39.0 to 50.0)
Week 18 Number Analyzed 330 participants
47.6
(42.1 to 53.1)
Week 30 Number Analyzed 319 participants
52.4
(46.7 to 57.9)
Week 42 Number Analyzed 310 participants
55.8
(50.1 to 61.4)
Week 54 Number Analyzed 296 participants
55.7
(49.9 to 61.5)
Week 66 Number Analyzed 284 participants
56.7
(50.7 to 62.5)
Week 78 Number Analyzed 272 participants
57.7
(51.6 to 63.7)
Week 90 Number Analyzed 261 participants
60.2
(53.9 to 66.1)
Week 102 Number Analyzed 245 participants
65.7
(59.4 to 71.6)
Week 114 Number Analyzed 231 participants
66.2
(59.7 to 72.3)
Week 126 Number Analyzed 215 participants
66.0
(59.3 to 72.3)
Week 138 Number Analyzed 196 participants
67.9
(60.8 to 74.3)
Week 150 Number Analyzed 180 participants
65.0
(57.6 to 71.9)
Week 162 Number Analyzed 154 participants
63.0
(54.8 to 70.6)
Week 174 Number Analyzed 142 participants
65.5
(57.1 to 73.3)
Week 186 Number Analyzed 128 participants
68.0
(59.1 to 75.9)
Week 198 Number Analyzed 113 participants
64.6
(55.0 to 73.4)
Week 210 Number Analyzed 89 participants
64.0
(53.2 to 73.9)
Week 222 Number Analyzed 71 participants
69.0
(56.9 to 79.5)
Week 234 Number Analyzed 51 participants
78.4
(64.7 to 88.7)
Week 246 Number Analyzed 42 participants
83.3
(68.6 to 93.0)
13.Secondary Outcome
Title 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
Hide Description Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence among participants with inactive uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used are as follows: CM=concomitant medications; NQ=non-quiescence.
Time Frame 366 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with inactive uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: percentage of participants
NQ With CM Change and quiescence at next visit 10.5
NQ With CM Change and nonquiescence at next visit 2.4
NQ Without CM Change and quiescence at next visit 13.7
NQ Without CM Change and NQ at next visit 8.9
NQ With Premature Discontinuation 3.2
NQ And Completion 0.8
14.Secondary Outcome
Title 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
Hide Description Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence, among participants with active uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used include: CM=concomitant medications, NQ=non-quiescence.
Time Frame 366 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with active uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 240
Measure Type: Number
Unit of Measure: percentage of participants
NQ With CM Change and quiescence at next visit 19.2
NQ With CM Change and nonquiescence at next visit 10.8
NQ Without CM Change and quiescence at next visit 15.0
NQ Without CM Change and NQ at next visit 15.4
NQ With Premature Discontinuation 6.7
NQ And Completion 0.4
15.Secondary Outcome
Title Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study
Hide Description Percentage of participants who started uveitis-related systemic corticosteroids during the study.
Time Frame 366 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set without systemic corticosteroids at baseline with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.3
(16.3 to 24.8)
16.Secondary Outcome
Title Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time
Hide Description Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with active uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 235
Mean (Standard Deviation)
Unit of Measure: milligrams
Week 0 Number Analyzed 235 participants
13.6  (19.21)
Week 2 Number Analyzed 235 participants
14.8  (17.12)
Week 4 Number Analyzed 230 participants
10.1  (12.27)
Week 8 Number Analyzed 227 participants
7.3  (9.75)
Week 12 Number Analyzed 222 participants
6.0  (9.34)
Week 18 Number Analyzed 216 participants
5.1  (8.47)
Week 30 Number Analyzed 207 participants
4.4  (7.12)
Week 42 Number Analyzed 196 participants
3.5  (5.54)
Week 54 Number Analyzed 188 participants
3.5  (6.71)
Week 66 Number Analyzed 179 participants
3.1  (6.32)
Week 78 Number Analyzed 171 participants
2.6  (5.10)
Week 90 Number Analyzed 164 participants
2.2  (4.47)
Week 102 Number Analyzed 155 participants
2.1  (4.80)
Week 114 Number Analyzed 148 participants
1.8  (4.50)
Week 126 Number Analyzed 139 participants
1.6  (4.16)
Week 138 Number Analyzed 132 participants
2.2  (5.65)
Week 150 Number Analyzed 122 participants
2.0  (4.49)
Week 162 Number Analyzed 115 participants
1.9  (4.31)
Week 174 Number Analyzed 109 participants
1.9  (4.46)
Week 186 Number Analyzed 96 participants
1.6  (4.27)
Week 198 Number Analyzed 86 participants
1.6  (4.05)
Week 210 Number Analyzed 74 participants
1.4  (3.57)
Week 222 Number Analyzed 59 participants
2.3  (8.48)
Week 234 Number Analyzed 42 participants
1.1  (3.17)
Week 246 Number Analyzed 35 participants
0.6  (1.69)
17.Secondary Outcome
Title Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time
Hide Description Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with inactive uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: milligrams
Week 0 Number Analyzed 124 participants
1.5  (7.32)
Week 2 Number Analyzed 124 participants
1.6  (6.65)
Week 4 Number Analyzed 123 participants
1.4  (4.89)
Week 8 Number Analyzed 117 participants
0.9  (3.41)
Week 12 Number Analyzed 115 participants
0.9  (4.12)
Week 18 Number Analyzed 114 participants
0.8  (3.29)
Week 30 Number Analyzed 113 participants
0.7  (2.74)
Week 42 Number Analyzed 112 participants
0.7  (2.64)
Week 54 Number Analyzed 108 participants
1.8  (7.09)
Week 66 Number Analyzed 103 participants
1.3  (5.32)
Week 78 Number Analyzed 99 participants
1.1  (4.36)
Week 90 Number Analyzed 95 participants
1.2  (4.54)
Week 102 Number Analyzed 91 participants
0.6  (2.63)
Week 114 Number Analyzed 84 participants
0.6  (2.67)
Week 126 Number Analyzed 77 participants
0.7  (2.95)
Week 138 Number Analyzed 64 participants
0.5  (2.09)
Week 150 Number Analyzed 59 participants
0.5  (1.91)
Week 162 Number Analyzed 39 participants
0.2  (1.00)
Week 174 Number Analyzed 34 participants
0.2  (1.07)
Week 186 Number Analyzed 31 participants
0.3  (1.12)
Week 198 Number Analyzed 26 participants
0.3  (1.23)
Week 210 Number Analyzed 16 participants
0.4  (1.50)
Week 222 Number Analyzed 12 participants
0.5  (1.73)
Week 234 Number Analyzed 9 participants
0.5  (1.57)
Week 246 Number Analyzed 7 participants
0.0  (0.00)
18.Secondary Outcome
Title 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
Hide Description Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data not presented after Week 198 as no participants remained on study as of Week 198.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set who received systemic corticosteroids at Week 0 with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 7
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
Week 2 Number Analyzed 7 participants
-11.8
(-21.6 to -2.1)
Week 4 Number Analyzed 7 participants
-46.6
(-64.2 to -29.0)
Week 8 Number Analyzed 7 participants
-64.5
(-88.1 to -40.8)
Week 12 Number Analyzed 7 participants
-29.7
(-91.5 to 32.1)
Week 18 Number Analyzed 7 participants
-30.8
(-128.4 to 66.7)
Week 30 Number Analyzed 6 participants
-25.0
(-159.6 to 109.5)
Week 42 Number Analyzed 6 participants
-36.7
(-150.4 to 76.9)
Week 54 Number Analyzed 5 participants
-11.9
(-186.2 to 162.5)
Week 66 Number Analyzed 5 participants
-25.1
(-156.9 to 106.6)
Week 78 Number Analyzed 5 participants
-28.3
(-157.9 to 101.2)
Week 90 Number Analyzed 5 participants
-27.5
(-162.6 to 107.6)
Week 102 Number Analyzed 4 participants
-78.1
(-120.7 to -35.4)
Week 114 Number Analyzed 4 participants
-84.2
(-96.8 to -67.2)
Week 126 Number Analyzed 4 participants
-88.9
(-113.9 to -63.9)
Week 138 Number Analyzed 2 participants
-95.9
(-148.4 to -43.3)
Week 150 Number Analyzed 2 participants
-99.5
(-106.3 to -92.7)
Week 162 Number Analyzed 1 participants
-100.0
(-100.0 to -100.0)
Week 174 Number Analyzed 1 participants
-100.0
(-100.0 to -100.0)
Week 186 Number Analyzed 1 participants
-100.0
(-100.0 to -100.0)
Week 198 Number Analyzed 1 participants
-100.0
(-100.0 to -100.0)
19.Secondary Outcome
Title 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
Hide Description Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set receiving systemic corticosteroids at Week 0 with evaluable data at a given timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 114
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
Week 2 Number Analyzed 114 participants
-4.6
(-14.2 to 5.0)
Week 4 Number Analyzed 112 participants
-25.0
(-38.6 to -11.4)
Week 8 Number Analyzed 112 participants
-41.7
(-55.0 to -28.4)
Week 12 Number Analyzed 107 participants
-46.3
(-65.0 to -27.7)
Week 18 Number Analyzed 106 participants
-55.1
(-73.1 to -37.1)
Week 30 Number Analyzed 102 participants
-62.8
(-78.1 to -47.5)
Week 42 Number Analyzed 96 participants
-73.4
(-85.0 to -61.9)
Week 54 Number Analyzed 93 participants
-73.2
(-85.3 to -61.0)
Week 66 Number Analyzed 87 participants
-77.1
(-89.3 to -64.9)
Week 78 Number Analyzed 84 participants
-77.3
(-90.2 to -64.4)
Week 90 Number Analyzed 80 participants
-82.1
(-93.3 to -70.9)
Week 102 Number Analyzed 76 participants
-78.8
(-95.7 to -62.0)
Week 114 Number Analyzed 72 participants
-82.0
(-96.8 to -66.9)
Week 126 Number Analyzed 65 participants
-82.8
(-98.6 to -66.9)
Week 138 Number Analyzed 62 participants
-87.8
(-94.2 to -81.4)
Week 150 Number Analyzed 57 participants
-86.9
(-94.5 to -79.2)
Week 162 Number Analyzed 55 participants
-90.7
(-94.9 to -86.4)
Week 174 Number Analyzed 52 participants
-91.4
(-95.8 to -86.9)
Week 186 Number Analyzed 47 participants
-90.3
(-95.9 to -84.7)
Week 198 Number Analyzed 42 participants
-91.0
(-96.6 to -85.5)
Week 210 Number Analyzed 38 participants
-89.9
(-96.8 to -82.9)
Week 222 Number Analyzed 30 participants
-87.1
(-102.0 to -72.2)
Week 234 Number Analyzed 20 participants
-93.8
(-103.8 to -83.9)
Week 246 Number Analyzed 18 participants
-98.3
(-101.3 to -95.4)
20.Secondary Outcome
Title Percentage of Participants Not Using Systemic Corticosteroids Over Time
Hide Description Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data presented for participants not using systemic corticosteroids at each timepoint.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 359
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 0 Number Analyzed 359 participants
66.3
(61.1 to 71.2)
Week 2 Number Analyzed 358 participants
58.7
(53.4 to 63.8)
Week 4 Number Analyzed 349 participants
60.2
(54.8 to 65.3)
Week 8 Number Analyzed 339 participants
61.9
(56.5 to 67.1)
Week 12 Number Analyzed 334 participants
64.7
(59.3 to 69.8)
Week 18 Number Analyzed 328 participants
68.3
(63.0 to 73.3)
Week 30 Number Analyzed 312 participants
70.2
(64.8 to 75.2)
Week 42 Number Analyzed 306 participants
70.9
(65.5 to 75.9)
Week 54 Number Analyzed 292 participants
71.9
(66.4 to 77.0)
Week 66 Number Analyzed 275 participants
73.1
(67.4 to 78.2)
Week 78 Number Analyzed 266 participants
75.2
(69.5 to 80.3)
Week 90 Number Analyzed 257 participants
77.0
(71.4 to 82.0)
Week 102 Number Analyzed 239 participants
80.8
(75.2 to 85.6)
Week 114 Number Analyzed 225 participants
83.6
(78.1 to 88.1)
Week 126 Number Analyzed 209 participants
84.2
(78.5 to 88.9)
Week 138 Number Analyzed 190 participants
82.1
(75.9 to 87.3)
Week 150 Number Analyzed 173 participants
81.5
(74.9 to 87.0)
Week 162 Number Analyzed 149 participants
80.5
(73.3 to 86.6)
Week 174 Number Analyzed 136 participants
79.4
(71.6 to 85.9)
Week 186 Number Analyzed 123 participants
80.5
(72.4 to 87.1)
Week 198 Number Analyzed 97 participants
80.4
(71.1 to 87.8)
Week 210 Number Analyzed 82 participants
81.7
(71.6 to 89.4)
Week 222 Number Analyzed 59 participants
86.4
(75.0 to 94.0)
Week 234 Number Analyzed 48 participants
89.6
(77.3 to 96.5)
Week 246 Number Analyzed 34 participants
94.1
(80.3 to 99.3)
21.Secondary Outcome
Title 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
Hide Description Percentage of participants at each study time point without a worsening of Best Corrected Visual Acuity (BCVA) by ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.
Time Frame Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 118 participants
100
(96.9 to 100)
Week 4 Number Analyzed 108 participants
99.1
(94.9 to 100)
Week 8 Number Analyzed 113 participants
100
(96.8 to 100)
Week 12 Number Analyzed 112 participants
100
(96.8 to 100)
Week 18 Number Analyzed 112 participants
100
(96.8 to 100)
Week 30 Number Analyzed 112 participants
99.1
(95.1 to 100)
Week 42 Number Analyzed 112 participants
98.2
(93.7 to 99.8)
Week 54 Number Analyzed 107 participants
97.2
(92.0 to 99.4)
Week 66 Number Analyzed 103 participants
98.1
(93.2 to 99.8)
Week 78 Number Analyzed 99 participants
97.0
(91.4 to 99.4)
Week 90 Number Analyzed 95 participants
98.9
(94.3 to 100)
Week 102 Number Analyzed 89 participants
97.8
(92.1 to 99.7)
Week 114 Number Analyzed 84 participants
97.6
(91.7 to 99.7)
Week 126 Number Analyzed 76 participants
96.1
(88.9 to 99.2)
Week 138 Number Analyzed 64 participants
96.9
(89.2 to 99.6)
Week 150 Number Analyzed 57 participants
100
(93.7 to 100)
Week 162 Number Analyzed 39 participants
100
(91.0 to 100)
Week 174 Number Analyzed 34 participants
100
(89.7 to 100)
Week 186 Number Analyzed 31 participants
100
(88.8 to 100)
Week 198 Number Analyzed 26 participants
100
(86.8 to 100)
Week 210 Number Analyzed 16 participants
100
(79.4 to 100)
Week 222 Number Analyzed 12 participants
91.7
(61.5 to 99.8)
Week 234 Number Analyzed 9 participants
88.9
(51.8 to 99.7)
Week 246 Number Analyzed 7 participants
85.7
(42.1 to 99.6)
22.Secondary Outcome
Title 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
Hide Description Percentage of participants at each study time point without a worsening of BCVA by ≥15 letters on the ETDRS in both eyes relative to Week 8 for participant who had active uveitis when they entered the study.
Time Frame Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 219 participants
96.8
(93.5 to 98.7)
Week 18 Number Analyzed 214 participants
96.3
(92.8 to 98.4)
Week 30 Number Analyzed 206 participants
96.6
(93.1 to 98.6)
Week 42 Number Analyzed 196 participants
94.9
(90.8 to 97.5)
Week 54 Number Analyzed 188 participants
94.7
(90.4 to 97.4)
Week 66 Number Analyzed 179 participants
93.3
(88.6 to 96.5)
Week 78 Number Analyzed 172 participants
93.6
(88.8 to 96.8)
Week 90 Number Analyzed 165 participants
96.4
(92.3 to 98.7)
Week 102 Number Analyzed 153 participants
94.8
(90.0 to 97.7)
Week 114 Number Analyzed 146 participants
93.8
(88.6 to 97.1)
Week 126 Number Analyzed 140 participants
95.0
(90.0 to 98.0)
Week 138 Number Analyzed 131 participants
93.9
(88.3 to 97.3)
Week 150 Number Analyzed 123 participants
92.7
(86.6 to 96.6)
Week 162 Number Analyzed 114 participants
93.9
(87.8 to 97.5)
Week 174 Number Analyzed 107 participants
91.6
(84.6 to 96.1)
Week 186 Number Analyzed 96 participants
92.7
(85.6 to 97.0)
Week 198 Number Analyzed 86 participants
95.3
(88.5 to 98.7)
Week 210 Number Analyzed 71 participants
95.8
(88.1 to 99.1)
Week 222 Number Analyzed 58 participants
96.6
(88.1 to 99.6)
Week 234 Number Analyzed 42 participants
95.2
(83.8 to 99.4)
Week 246 Number Analyzed 34 participants
91.2
(76.3 to 98.1)
23.Secondary Outcome
Title Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time
Hide Description Using corrective lenses based on that visit's refraction testing, participant's BCVA was measured using an ETDRS logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 to 0.1; higher values indicate visual impairment. Data presented includes the mean of both eyes for all participants (active or inactive uveitis) for all study time points.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each study timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 364
Mean (Standard Deviation)
Unit of Measure: Log (Mar) BCVA Both Eyes
Week 0 Number Analyzed 364 participants
0.20  (0.275)
Week 2 Number Analyzed 348 participants
0.17  (0.265)
Week 4 Number Analyzed 325 participants
0.15  (0.248)
Week 8 Number Analyzed 342 participants
0.14  (0.247)
Week 12 Number Analyzed 333 participants
0.13  (0.244)
Week 18 Number Analyzed 329 participants
0.12  (0.240)
Week 30 Number Analyzed 319 participants
0.12  (0.249)
Week 42 Number Analyzed 309 participants
0.12  (0.227)
Week 54 Number Analyzed 296 participants
0.11  (0.238)
Week 66 Number Analyzed 284 participants
0.11  (0.241)
Week 78 Number Analyzed 272 participants
0.11  (0.238)
Week 90 Number Analyzed 261 participants
0.09  (0.214)
Week 102 Number Analyzed 244 participants
0.09  (0.219)
Week 114 Number Analyzed 231 participants
0.09  (0.233)
Week 126 Number Analyzed 217 participants
0.09  (0.231)
Week 138 Number Analyzed 197 participants
0.09  (0.224)
Week 150 Number Analyzed 181 participants
0.10  (0.255)
Week 162 Number Analyzed 154 participants
0.09  (0.249)
Week 174 Number Analyzed 142 participants
0.09  (0.261)
Week 186 Number Analyzed 128 participants
0.09  (0.244)
Week 198 Number Analyzed 113 participants
0.07  (0.205)
Week 210 Number Analyzed 88 participants
0.07  (0.211)
Week 222 Number Analyzed 71 participants
0.07  (0.218)
Week 234 Number Analyzed 51 participants
0.07  (0.222)
Week 246 Number Analyzed 41 participants
0.08  (0.217)
24.Other Pre-specified Outcome
Title Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
Hide Description Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in left eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.
Time Frame Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 111
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
Week 2 Number Analyzed 111 participants
0.3
(-1.41 to 1.97)
Week 4 Number Analyzed 100 participants
-0.2
(-2.03 to 1.56)
Week 8 Number Analyzed 106 participants
-0.7
(-2.07 to 0.72)
Week 12 Number Analyzed 105 participants
-1.0
(-2.27 to 0.23)
Week 18 Number Analyzed 105 participants
-0.5
(-2.02 to 1.07)
Week 30 Number Analyzed 104 participants
-1.9
(-3.25 to -0.60)
Week 42 Number Analyzed 103 participants
-1.3
(-2.83 to 0.17)
Week 54 Number Analyzed 101 participants
-2.1
(-3.90 to -0.22)
Week 66 Number Analyzed 96 participants
-1.9
(-3.95 to 0.11)
Week 78 Number Analyzed 88 participants
-1.4
(-4.54 to 1.70)
Week 90 Number Analyzed 85 participants
-2.9
(-4.51 to -1.22)
Week 102 Number Analyzed 82 participants
-3.1
(-4.95 to -1.34)
Week 114 Number Analyzed 75 participants
-2.8
(-4.44 to -1.14)
Week 126 Number Analyzed 67 participants
-3.7
(-5.66 to -1.68)
Week 138 Number Analyzed 58 participants
-3.4
(-5.38 to -1.46)
Week 150 Number Analyzed 52 participants
-3.5
(-5.48 to -1.58)
Week 162 Number Analyzed 32 participants
-3.3
(-6.25 to -0.29)
Week 174 Number Analyzed 29 participants
-3.0
(-5.45 to -0.52)
Week 186 Number Analyzed 27 participants
-3.8
(-6.69 to -1.00)
Week 198 Number Analyzed 23 participants
-3.2
(-5.99 to -0.35)
Week 210 Number Analyzed 13 participants
-5.2
(-10.23 to -0.17)
Week 222 Number Analyzed 10 participants
-4.6
(-11.17 to 1.93)
Week 234 Number Analyzed 8 participants
-3.6
(-13.06 to 5.77)
Week 246 Number Analyzed 6 participants
-3.4
(-14.83 to 7.93)
25.Other Pre-specified Outcome
Title Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
Hide Description Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in right eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.
Time Frame Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 109
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
Week 2 Number Analyzed 109 participants
-0.2
(-1.92 to 1.45)
Week 4 Number Analyzed 99 participants
-0.8
(-2.99 to 1.39)
Week 8 Number Analyzed 104 participants
-1.5
(-3.19 to 0.25)
Week 12 Number Analyzed 103 participants
-1.0
(-2.76 to 0.66)
Week 18 Number Analyzed 103 participants
-0.4
(-2.73 to 1.84)
Week 30 Number Analyzed 102 participants
-2.8
(-4.78 to -0.86)
Week 42 Number Analyzed 101 participants
-2.2
(-4.31 to -0.15)
Week 54 Number Analyzed 99 participants
-3.7
(-6.00 to -1.44)
Week 66 Number Analyzed 94 participants
-3.3
(-5.66 to -0.97)
Week 78 Number Analyzed 86 participants
-3.9
(-6.36 to -1.38)
Week 90 Number Analyzed 83 participants
-3.8
(-6.47 to -1.08)
Week 102 Number Analyzed 80 participants
-5.3
(-7.99 to -2.67)
Week 114 Number Analyzed 73 participants
-5.6
(-8.65 to -2.53)
Week 126 Number Analyzed 65 participants
-5.4
(-8.57 to -2.21)
Week 138 Number Analyzed 56 participants
-4.7
(-7.75 to -1.72)
Week 150 Number Analyzed 51 participants
-2.1
(-9.07 to 4.90)
Week 162 Number Analyzed 32 participants
-2.9
(-6.06 to 0.36)
Week 174 Number Analyzed 29 participants
-2.7
(-5.88 to 0.56)
Week 186 Number Analyzed 27 participants
-2.0
(-5.49 to 1.46)
Week 198 Number Analyzed 23 participants
-1.2
(-5.91 to 3.48)
Week 210 Number Analyzed 13 participants
-2.3
(-6.35 to 1.66)
Week 222 Number Analyzed 10 participants
-1.7
(-4.76 to 1.44)
Week 234 Number Analyzed 8 participants
-1.3
(-6.32 to 3.78)
Week 246 Number Analyzed 6 participants
1.6
(-0.78 to 3.93)
26.Other Pre-specified Outcome
Title Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
Hide Description Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in left eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.
Time Frame Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 206
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
Week 12 Number Analyzed 206 participants
1.0
(-0.50 to 2.42)
Week 18 Number Analyzed 201 participants
-0.3
(-2.36 to 1.71)
Week 30 Number Analyzed 194 participants
-2.4
(-4.24 to -0.55)
Week 42 Number Analyzed 183 participants
-2.8
(-4.62 to -1.00)
Week 54 Number Analyzed 177 participants
-3.2
(-5.52 to -0.90)
Week 66 Number Analyzed 166 participants
-2.3
(-4.52 to 0.01)
Week 78 Number Analyzed 161 participants
-3.5
(-5.99 to -1.02)
Week 90 Number Analyzed 150 participants
-4.8
(-7.19 to -2.42)
Week 102 Number Analyzed 142 participants
-5.3
(-7.41 to -3.10)
Week 114 Number Analyzed 126 participants
-6.6
(-9.15 to -3.95)
Week 126 Number Analyzed 124 participants
-5.3
(-8.66 to -1.92)
Week 138 Number Analyzed 118 participants
-7.0
(-9.96 to -3.99)
Week 150 Number Analyzed 109 participants
-7.3
(-10.22 to -4.48)
Week 162 Number Analyzed 104 participants
-7.5
(-11.31 to -3.72)
Week 174 Number Analyzed 92 participants
-9.5
(-13.20 to -5.81)
Week 186 Number Analyzed 83 participants
-7.6
(-10.21 to -4.93)
Week 198 Number Analyzed 74 participants
-8.4
(-11.84 to -4.99)
Week 210 Number Analyzed 67 participants
-6.6
(-10.40 to -2.74)
Week 222 Number Analyzed 53 participants
-9.3
(-13.42 to -5.17)
Week 234 Number Analyzed 39 participants
-8.2
(-11.85 to -4.46)
Week 246 Number Analyzed 32 participants
-9.1
(-13.41 to -4.82)
27.Other Pre-specified Outcome
Title Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
Hide Description Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in right eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.
Time Frame Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 205
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
Week 12 Number Analyzed 205 participants
0.4
(-1.58 to 2.47)
Week 18 Number Analyzed 202 participants
-0.7
(-2.71 to 1.30)
Week 30 Number Analyzed 194 participants
-0.7
(-3.36 to 1.90)
Week 42 Number Analyzed 183 participants
-2.4
(-4.85 to 0.05)
Week 54 Number Analyzed 176 participants
-2.4
(-5.25 to 0.36)
Week 66 Number Analyzed 167 participants
-1.3
(-4.81 to 2.27)
Week 78 Number Analyzed 160 participants
-2.1
(-5.61 to 1.50)
Week 90 Number Analyzed 149 participants
-3.6
(-6.44 to -0.76)
Week 102 Number Analyzed 142 participants
-3.4
(-6.98 to 0.13)
Week 114 Number Analyzed 125 participants
-2.2
(-6.18 to 1.81)
Week 126 Number Analyzed 124 participants
-3.5
(-7.43 to 0.47)
Week 138 Number Analyzed 118 participants
-4.6
(-8.22 to -0.92)
Week 150 Number Analyzed 109 participants
-6.5
(-9.81 to -3.15)
Week 162 Number Analyzed 104 participants
-4.8
(-8.91 to -0.75)
Week 174 Number Analyzed 93 participants
-5.4
(-9.46 to -1.27)
Week 186 Number Analyzed 83 participants
-7.9
(-12.74 to -3.03)
Week 198 Number Analyzed 75 participants
-8.2
(-12.30 to -4.13)
Week 210 Number Analyzed 67 participants
-6.6
(-10.76 to -2.43)
Week 222 Number Analyzed 52 participants
-9.7
(-13.24 to -6.19)
Week 234 Number Analyzed 39 participants
-9.7
(-14.24 to -5.07)
Week 246 Number Analyzed 32 participants
-9.9
(-15.43 to -4.35)
28.Other Pre-specified Outcome
Title Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time
Hide Description Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm * 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0: ˂ 1 cell; Grade 0.5+: 1 - 5 cells; Grade 1+: 6 - 15 cells; Grade 2+: 16 - 25 cells; Grade 3+: 26 - 50 cells; and Grade 4+: ≥ 50 cells.
Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:

Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.

adalimumab: Adalimumab, pre-filled syringe, administered by SC injection

Overall Number of Participants Analyzed 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 0 Number Analyzed 364 participants
65.4
(60.3 to 70.3)
Week 2 Number Analyzed 348 participants
85.9
(81.8 to 89.4)
Week 4 Number Analyzed 323 participants
90.4
(86.7 to 93.4)
Week 8 Number Analyzed 343 participants
91.5
(88.1 to 94.3)
Week 12 Number Analyzed 333 participants
91.3
(87.7 to 94.1)
Week 18 Number Analyzed 330 participants
90.9
(87.3 to 93.8)
Week 30 Number Analyzed 319 participants
94.7
(91.6 to 96.9)
Week 42 Number Analyzed 310 participants
92.3
(88.7 to 95.0)
Week 54 Number Analyzed 296 participants
92.9
(89.4 to 95.6)
Week 66 Number Analyzed 284 participants
95.1
(91.9 to 97.3)
Week 78 Number Analyzed 272 participants
93.0
(89.3 to 95.7)
Week 90 Number Analyzed 261 participants
94.3
(90.7 to 96.7)
Week 102 Number Analyzed 245 participants
93.5
(89.6 to 96.2)
Week 114 Number Analyzed 231 participants
93.5
(89.5 to 96.3)
Week 126 Number Analyzed 217 participants
94.0
(90.0 to 96.8)
Week 138 Number Analyzed 197 participants
93.4
(89.0 to 96.4)
Week 150 Number Analyzed 181 participants
94.5
(90.1 to 97.3)
Week 162 Number Analyzed 154 participants
95.5
(90.9 to 98.2)
Week 174 Number Analyzed 142 participants
94.4
(89.2 to 97.5)
Week 186 Number Analyzed 128 participants
96.1
(91.1 to 98.7)
Week 198 Number Analyzed 113 participants
94.7
(88.8 to 98.0)
Week 210 Number Analyzed 89 participants
96.6
(90.5 to 99.3)
Week 222 Number Analyzed 71 participants
98.6
(92.4 to 100)
Week 234 Number Analyzed 51 participants
100
(93.0 to 100)
Week 246 Number Analyzed 42 participants
95.2
(83.8 to 99.4)
29.Other Pre-specified Outcome
Title Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
Hide Description Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. Data not presented after Week 234 as no participants remained on study as of Week 234.
Time Frame Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, and 234
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 0) with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 55 participants
3.6
(0.4 to 12.5)
Week 4 Number Analyzed 55 participants
9.1
(3.0 to 20.0)
Week 8 Number Analyzed 52 participants
17.3
(8.2 to 30.3)
Week 12 Number Analyzed 52 participants
17.3
(8.2 to 30.3)
Week 18 Number Analyzed 51 participants
21.6
(11.3 to 35.3)
Week 30 Number Analyzed 49 participants
24.5
(13.3 to 38.9)
Week 42 Number Analyzed 48 participants
22.9
(12.0 to 37.3)
Week 54 Number Analyzed 45 participants
17.8
(8.0 to 32.1)
Week 66 Number Analyzed 40 participants
15.0
(5.7 to 29.8)
Week 78 Number Analyzed 40 participants
15.0
(5.7 to 29.8)
Week 90 Number Analyzed 37 participants
13.5
(4.5 to 28.8)
Week 102 Number Analyzed 34 participants
14.7
(5.0 to 31.1)
Week 114 Number Analyzed 32 participants
25.0
(11.5 to 43.4)
Week 126 Number Analyzed 28 participants
25.0
(10.7 to 44.9)
Week 138 Number Analyzed 24 participants
25.0
(9.8 to 46.7)
Week 150 Number Analyzed 21 participants
23.8
(8.2 to 47.2)
Week 162 Number Analyzed 16 participants
18.8
(4.0 to 45.6)
Week 174 Number Analyzed 16 participants
12.5
(1.6 to 38.3)
Week 186 Number Analyzed 16 participants
12.5
(1.6 to 38.3)
Week 198 Number Analyzed 10 participants
0
(0 to 0)
Week 210 Number Analyzed 8 participants
12.5
(0.3 to 52.7)
Week 222 Number Analyzed 4 participants
25.0
(0.6 to 80.6)
Week 234 Number Analyzed 4 participants
50.0
(6.8 to 93.2)
30.Other Pre-specified Outcome
Title Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
Hide Description Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit.
Time Frame Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 8) with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 140 participants
17.1
(11.3 to 24.4)
Week 18 Number Analyzed 136 participants
27.2
(19.9 to 35.5)
Week 30 Number Analyzed 128 participants
33.6
(25.5 to 42.5)
Week 42 Number Analyzed 125 participants
41.6
(32.9 to 50.8)
Week 54 Number Analyzed 119 participants
44.5
(35.4 to 53.9)
Week 66 Number Analyzed 113 participants
48.7
(39.2 to 58.3)
Week 78 Number Analyzed 109 participants
48.6
(38.9 to 58.4)
Week 90 Number Analyzed 106 participants
53.8
(43.8 to 63.5)
Week 102 Number Analyzed 98 participants
54.1
(43.7 to 64.2)
Week 114 Number Analyzed 90 participants
51.1
(40.3 to 61.8)
Week 126 Number Analyzed 87 participants
52.9
(41.9 to 63.7)
Week 138 Number Analyzed 80 participants
52.5
(41.0 to 63.8)
Week 150 Number Analyzed 76 participants
53.9
(42.1 to 65.5)
Week 162 Number Analyzed 71 participants
53.5
(41.3 to 65.5)
Week 174 Number Analyzed 63 participants
55.6
(42.5 to 68.1)
Week 186 Number Analyzed 59 participants
55.9
(42.4 to 68.8)
Week 198 Number Analyzed 50 participants
52.0
(37.4 to 66.3)
Week 210 Number Analyzed 41 participants
51.2
(35.1 to 67.1)
Week 222 Number Analyzed 31 participants
54.8
(36.0 to 72.7)
Week 234 Number Analyzed 23 participants
56.5
(34.5 to 76.8)
Week 246 Number Analyzed 19 participants
63.2
(38.4 to 83.7)
31.Other Pre-specified Outcome
Title Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
Hide Description Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.
Time Frame Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set that had evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
Overall Number of Participants Analyzed 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 118 participants
100
(96.9 to 100)
Week 4 Number Analyzed 107 participants
99.1
(94.9 to 100)
Week 8 Number Analyzed 113 participants
100
(96.8 to 100)
Week 12 Number Analyzed 112 participants
100
(96.8 to 100)
Week 18 Number Analyzed 112 participants
98.2
(93.7 to 99.8)
Week 30 Number Analyzed 112 participants
100
(96.8 to 100)
Week 42 Number Analyzed 112 participants
98.2
(93.7 to 99.8)
Week 54 Number Analyzed 107 participants
99.1
(94.9 to 100)
Week 66 Number Analyzed 103 participants
100
(96.5 to 100)
Week 78 Number Analyzed 99 participants
100
(96.3 to 100)
Week 90 Number Analyzed 95 participants
98.9
(94.3 to 100)
Week 102 Number Analyzed 89 participants
98.9
(93.9 to 100)
Week 114 Number Analyzed 84 participants
100
(95.7 to 100)
Week 126 Number Analyzed 75 participants
100
(95.2 to 100)
Week 138 Number Analyzed 64 participants
98.4
(91.6 to 100)
Week 150 Number Analyzed 57 participants
96.5
(87.9 to 99.6)
Week 162 Number Analyzed 39 participants
97.4
(86.5 to 99.9)
Week 174 Number Analyzed 34 participants
100
(89.7 to 100)
Week 186 Number Analyzed 31 participants
100
(88.8 to 100)
Week 198 Number Analyzed 26 participants
100
(86.8 to 100)
Week 210 Number Analyzed 16 participants
100
(79.4 to 100)
Week 222 Number Analyzed 12 participants
100
(73.5 to 100)
Week 234 Number Analyzed 9 participants
100
(66.4 to 100)
Week 246 Number Analyzed 7 participants
100
(59.0 to 100)
32.Other Pre-specified Outcome
Title Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
Hide Description Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for participants who had active uveitis when they entered the study.
Time Frame Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 221 participants
97.7
(94.8 to 99.3)
Week 18 Number Analyzed 218 participants
99.1
(96.7 to 99.9)
Week 30 Number Analyzed 207 participants
97.1
(93.8 to 98.9)
Week 42 Number Analyzed 198 participants
99.0
(96.4 to 99.9)
Week 54 Number Analyzed 188 participants
98.9
(96.2 to 99.9)
Week 66 Number Analyzed 181 participants
98.3
(95.2 to 99.7)
Week 78 Number Analyzed 173 participants
97.7
(94.2 to 99.4)
Week 90 Number Analyzed 166 participants
97.6
(93.9 to 99.3)
Week 102 Number Analyzed 156 participants
99.4
(96.5 to 100)
Week 114 Number Analyzed 147 participants
97.3
(93.2 to 99.3)
Week 126 Number Analyzed 140 participants
99.3
(96.1 to 100)
Week 138 Number Analyzed 132 participants
100
(97.2 to 100)
Week 150 Number Analyzed 123 participants
96.7
(91.9 to 99.1)
Week 162 Number Analyzed 115 participants
97.4
(92.6 to 99.5)
Week 174 Number Analyzed 108 participants
100
(96.6 to 100)
Week 186 Number Analyzed 97 participants
99.0
(94.4 to 100)
Week 198 Number Analyzed 87 participants
100
(95.8 to 100)
Week 210 Number Analyzed 73 participants
100
(95.1 to 100)
Week 222 Number Analyzed 59 participants
100
(93.9 to 100)
Week 234 Number Analyzed 42 participants
100
(91.6 to 100)
Week 246 Number Analyzed 35 participants
100
(90.0 to 100)
33.Other Pre-specified Outcome
Title Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time
Hide Description

Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to NEI and SUN criteria:

Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured.

Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 0 Number Analyzed 364 participants
58.0
(52.7 to 63.1)
Week 2 Number Analyzed 348 participants
75.6
(70.7 to 80.0)
Week 4 Number Analyzed 323 participants
77.7
(72.8 to 82.1)
Week 8 Number Analyzed 342 participants
84.2
(79.9 to 87.9)
Week 12 Number Analyzed 333 participants
84.4
(80.0 to 88.1)
Week 18 Number Analyzed 330 participants
87.3
(83.2 to 90.7)
Week 30 Number Analyzed 319 participants
87.1
(83.0 to 90.6)
Week 42 Number Analyzed 310 participants
90.3
(86.5 to 93.4)
Week 54 Number Analyzed 295 participants
89.5
(85.4 to 92.7)
Week 66 Number Analyzed 283 participants
92.2
(88.5 to 95.1)
Week 78 Number Analyzed 270 participants
93.3
(89.7 to 96.0)
Week 90 Number Analyzed 261 participants
93.5
(89.8 to 96.2)
Week 102 Number Analyzed 245 participants
93.9
(90.1 to 96.5)
Week 114 Number Analyzed 231 participants
93.1
(89.0 to 96.0)
Week 126 Number Analyzed 215 participants
94.9
(91.0 to 97.4)
Week 138 Number Analyzed 196 participants
95.4
(91.5 to 97.9)
Week 150 Number Analyzed 180 participants
92.2
(87.3 to 95.7)
Week 162 Number Analyzed 154 participants
91.6
(86.0 to 95.4)
Week 174 Number Analyzed 142 participants
92.3
(86.6 to 96.1)
Week 186 Number Analyzed 128 participants
96.1
(91.1 to 98.7)
Week 198 Number Analyzed 113 participants
93.8
(87.7 to 97.5)
Week 210 Number Analyzed 88 participants
92.0
(84.3 to 96.7)
Week 222 Number Analyzed 70 participants
95.7
(88.0 to 99.1)
Week 234 Number Analyzed 51 participants
96.1
(86.5 to 99.5)
Week 246 Number Analyzed 42 participants
97.6
(87.4 to 99.9)
34.Other Pre-specified Outcome
Title Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
Hide Description The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 0 for participants with inactive uveitis.
Time Frame Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 122
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Week 0 Number Analyzed 122 participants
84.77
(81.93 to 87.62)
Week 8 Number Analyzed 111 participants
84.37
(81.37 to 87.37)
Week 18 Number Analyzed 112 participants
85.21
(82.30 to 88.13)
Week 30 Number Analyzed 111 participants
84.75
(81.91 to 87.59)
Week 42 Number Analyzed 111 participants
84.41
(81.29 to 87.53)
Week 54 Number Analyzed 105 participants
84.87
(81.82 to 87.91)
Week 66 Number Analyzed 103 participants
84.09
(80.97 to 87.21)
Week 78 Number Analyzed 99 participants
83.59
(80.33 to 86.85)
Week 90 Number Analyzed 95 participants
83.66
(80.18 to 87.15)
Week 102 Number Analyzed 89 participants
84.19
(80.62 to 87.76)
Week 114 Number Analyzed 83 participants
84.09
(80.40 to 87.78)
Week 126 Number Analyzed 76 participants
84.44
(80.59 to 88.28)
Week 138 Number Analyzed 64 participants
84.85
(80.56 to 89.14)
Week 150 Number Analyzed 57 participants
83.90
(78.95 to 88.85)
Week 162 Number Analyzed 39 participants
86.60
(81.31 to 91.90)
Week 174 Number Analyzed 34 participants
87.25
(81.51 to 92.99)
Week 186 Number Analyzed 31 participants
87.25
(81.43 to 93.06)
Week 198 Number Analyzed 26 participants
85.30
(78.35 to 92.26)
Week 210 Number Analyzed 16 participants
85.71
(76.61 to 94.82)
Week 222 Number Analyzed 12 participants
85.67
(74.60 to 96.74)
Week 234 Number Analyzed 9 participants
82.90
(68.16 to 97.63)
Week 246 Number Analyzed 7 participants
79.83
(61.00 to 98.66)
35.Other Pre-specified Outcome
Title Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
Hide Description The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 8 for participants with active uveitis.
Time Frame Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the ITT analysis set with evaluable data at each timepoint.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Number of Participants Analyzed 240
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Week 0 Number Analyzed 240 participants
72.00
(69.52 to 74.48)
Week 8 Number Analyzed 226 participants
75.77
(73.27 to 78.26)
Week 18 Number Analyzed 215 participants
78.12
(75.65 to 80.58)
Week 30 Number Analyzed 206 participants
78.98
(76.46 to 81.50)
Week 42 Number Analyzed 197 participants
79.77
(77.37 to 82.18)
Week 54 Number Analyzed 188 participants
80.10
(77.69 to 82.50)
Week 66 Number Analyzed 180 participants
80.42
(77.87 to 82.97)
Week 78 Number Analyzed 169 participants
80.98
(78.39 to 83.58)
Week 90 Number Analyzed 163 participants
81.85
(79.32 to 84.37)
Week 102 Number Analyzed 156 participants
81.44
(78.74 to 84.14)
Week 114 Number Analyzed 146 participants
81.76
(78.99 to 84.54)
Week 126 Number Analyzed 140 participants
81.86
(79.11 to 84.61)
Week 138 Number Analyzed 133 participants
81.76
(78.94 to 84.59)
Week 150 Number Analyzed 123 participants
82.41
(79.51 to 85.31)
Week 162 Number Analyzed 115 participants
81.87
(78.90 to 84.85)
Week 174 Number Analyzed 108 participants
81.96
(78.78 to 85.14)
Week 186 Number Analyzed 97 participants
81.27
(78.07 to 84.46)
Week 198 Number Analyzed 87 participants
82.08
(78.82 to 85.34)
Week 210 Number Analyzed 72 participants
80.75
(76.99 to 84.51)
Week 222 Number Analyzed 59 participants
81.65
(77.24 to 86.05)
Week 234 Number Analyzed 42 participants
81.86
(76.32 to 87.40)
Week 246 Number Analyzed 35 participants
81.57
(75.44 to 87.70)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks).
Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   4/424 (0.94%)    
Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%) # Events
Total   101/424 (23.82%)    
Blood and lymphatic system disorders   
PSEUDOLYMPHOMA  1  1/424 (0.24%)  1
Cardiac disorders   
ACUTE MYOCARDIAL INFARCTION  1  1/424 (0.24%)  1
AORTIC VALVE STENOSIS  1  1/424 (0.24%)  1
CARDIAC FAILURE ACUTE  1  1/424 (0.24%)  1
CORONARY ARTERY DISEASE  1  1/424 (0.24%)  1
MYOCARDIAL INFARCTION  1  1/424 (0.24%)  1
Congenital, familial and genetic disorders   
BICUSPID AORTIC VALVE  1  1/424 (0.24%)  1
Eye disorders   
BLINDNESS  1  1/424 (0.24%)  1
CATARACT  1  7/424 (1.65%)  11
CILIARY ZONULAR DEHISCENCE  1  1/424 (0.24%)  1
CORNEAL OEDEMA  1  1/424 (0.24%)  1
EYE INFLAMMATION  1  1/424 (0.24%)  1
GLAUCOMA  1  1/424 (0.24%)  1
MACULAR FIBROSIS  1  1/424 (0.24%)  1
OCULAR HYPERTENSION  1  1/424 (0.24%)  1
OPTIC NEUROPATHY  1  1/424 (0.24%)  1
PAPILLOEDEMA  1  1/424 (0.24%)  1
RETINAL DETACHMENT  1  3/424 (0.71%)  3
RETINAL VASCULITIS  1  1/424 (0.24%)  1
UVEITIS  1  5/424 (1.18%)  5
VISUAL ACUITY REDUCED  1  2/424 (0.47%)  2
VITREOUS FLOATERS  1  1/424 (0.24%)  1
VITREOUS HAEMORRHAGE  1  3/424 (0.71%)  3
VITREOUS OPACITIES  1  1/424 (0.24%)  1
Gastrointestinal disorders   
COLITIS  1  1/424 (0.24%)  1
CROHN'S DISEASE  1  2/424 (0.47%)  2
GASTRIC ULCER  1  1/424 (0.24%)  1
GASTRITIS  1  1/424 (0.24%)  1
INTESTINAL OBSTRUCTION  1  1/424 (0.24%)  1
LARGE INTESTINE POLYP  1  2/424 (0.47%)  2
PANCREATITIS  1  1/424 (0.24%)  1
General disorders   
CHEST PAIN  1  2/424 (0.47%)  2
DEATH  1  1/424 (0.24%)  1
GENERALISED OEDEMA  1  1/424 (0.24%)  1
Hepatobiliary disorders   
BILIARY COLIC  1  1/424 (0.24%)  1
CHOLELITHIASIS  1  3/424 (0.71%)  3
Immune system disorders   
SARCOIDOSIS  1  1/424 (0.24%)  1
Infections and infestations   
APPENDICITIS  1  1/424 (0.24%)  1
APPENDICITIS PERFORATED  1  1/424 (0.24%)  1
ASPERGILLUS INFECTION  1  1/424 (0.24%)  1
BRAIN ABSCESS  1  1/424 (0.24%)  1
CELLULITIS  1  1/424 (0.24%)  1
CYTOMEGALOVIRUS CHORIORETINITIS  1  1/424 (0.24%)  2
CYTOMEGALOVIRUS INFECTION  1  1/424 (0.24%)  1
DEVICE RELATED INFECTION  1  1/424 (0.24%)  1
DIVERTICULITIS  1  2/424 (0.47%)  3
ESCHERICHIA URINARY TRACT INFECTION  1  1/424 (0.24%)  1
GASTROENTERITIS  1  1/424 (0.24%)  1
INFECTION  1  1/424 (0.24%)  1
LATENT TUBERCULOSIS  1  1/424 (0.24%)  1
MENINGITIS  1  1/424 (0.24%)  1
OPHTHALMIC HERPES ZOSTER  1  1/424 (0.24%)  1
PERITONSILLAR ABSCESS  1  1/424 (0.24%)  1
PNEUMONIA  1  3/424 (0.71%)  3
PYELONEPHRITIS  1  2/424 (0.47%)  2
PYONEPHROSIS  1  1/424 (0.24%)  1
SEPTIC SHOCK  1  1/424 (0.24%)  1
SINUSITIS  1  2/424 (0.47%)  2
SINUSITIS FUNGAL  1  1/424 (0.24%)  1
SOFT TISSUE INFECTION  1  1/424 (0.24%)  1
SUBCUTANEOUS ABSCESS  1  1/424 (0.24%)  1
TOOTH ABSCESS  1  1/424 (0.24%)  1
TUBERCULOSIS  1  1/424 (0.24%)  1
URINARY TRACT INFECTION  1  5/424 (1.18%)  5
UROSEPSIS  1  1/424 (0.24%)  1
Injury, poisoning and procedural complications   
COMMINUTED FRACTURE  1  1/424 (0.24%)  1
CORNEAL ABRASION  1  1/424 (0.24%)  1
ELSCHNIG'S BODIES  1  1/424 (0.24%)  1
EPICONDYLITIS  1  1/424 (0.24%)  1
FALL  1  1/424 (0.24%)  1
FOREARM FRACTURE  1  1/424 (0.24%)  1
JOINT DISLOCATION  1  1/424 (0.24%)  1
LACERATION  1  1/424 (0.24%)  1
POST PROCEDURAL HAEMORRHAGE  1  1/424 (0.24%)  1
SPINAL COMPRESSION FRACTURE  1  2/424 (0.47%)  2
STRESS FRACTURE  1  1/424 (0.24%)  1
TIBIA FRACTURE  1  1/424 (0.24%)  1
UPPER LIMB FRACTURE  1  1/424 (0.24%)  1
Investigations   
CARDIAC MURMUR  1  1/424 (0.24%)  1
HEPATIC ENZYME INCREASED  1  1/424 (0.24%)  1
INTRAOCULAR PRESSURE INCREASED  1  1/424 (0.24%)  1
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE  1  1/424 (0.24%)  1
TUBERCULIN TEST POSITIVE  1  1/424 (0.24%)  1
Metabolism and nutrition disorders   
HYPOGLYCAEMIA  1  1/424 (0.24%)  1
OBESITY  1  3/424 (0.71%)  3
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/424 (0.47%)  2
MUSCULOSKELETAL PAIN  1  1/424 (0.24%)  1
MYOPATHY  1  1/424 (0.24%)  1
OSTEOARTHRITIS  1  2/424 (0.47%)  2
OSTEOLYSIS  1  1/424 (0.24%)  1
PATELLOFEMORAL PAIN SYNDROME  1  1/424 (0.24%)  1
SYNOVITIS  1  1/424 (0.24%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ADENOCARCINOMA OF COLON  1  1/424 (0.24%)  1
B-CELL LYMPHOMA  1  1/424 (0.24%)  1
BASAL CELL CARCINOMA  1  2/424 (0.47%)  2
COLORECTAL CANCER  1  1/424 (0.24%)  1
LOBULAR BREAST CARCINOMA IN SITU  1  1/424 (0.24%)  1
PANCREATIC CARCINOMA METASTATIC  1  1/424 (0.24%)  1
RECTAL ADENOCARCINOMA  1  1/424 (0.24%)  1
SQUAMOUS CELL CARCINOMA OF SKIN  1  1/424 (0.24%)  1
UTERINE LEIOMYOMA  1  1/424 (0.24%)  1
Nervous system disorders   
ATAXIA  1  1/424 (0.24%)  1
DEMYELINATION  1  1/424 (0.24%)  1
ENCEPHALITIS AUTOIMMUNE  1  1/424 (0.24%)  1
MULTIPLE SCLEROSIS  1  2/424 (0.47%)  2
TENSION HEADACHE  1  1/424 (0.24%)  1
TRANSIENT ISCHAEMIC ATTACK  1  1/424 (0.24%)  1
Pregnancy, puerperium and perinatal conditions   
ECTOPIC PREGNANCY  1  1/424 (0.24%)  1
HYPEREMESIS GRAVIDARUM  1  1/424 (0.24%)  1
Product Issues   
DEVICE DISLOCATION  1  1/424 (0.24%)  1
Renal and urinary disorders   
ACUTE KIDNEY INJURY  1  1/424 (0.24%)  1
BLADDER DIVERTICULUM  1  1/424 (0.24%)  1
MICTURITION DISORDER  1  1/424 (0.24%)  1
NEPHROLITHIASIS  1  2/424 (0.47%)  4
RENAL COLIC  1  1/424 (0.24%)  1
URETEROLITHIASIS  1  1/424 (0.24%)  1
Reproductive system and breast disorders   
CYSTOCELE  1  1/424 (0.24%)  1
HYDROCELE FEMALE  1  1/424 (0.24%)  1
RECTOCELE  1  1/424 (0.24%)  1
VAGINAL HAEMORRHAGE  1  1/424 (0.24%)  1
Respiratory, thoracic and mediastinal disorders   
ACUTE RESPIRATORY FAILURE  1  1/424 (0.24%)  1
NASAL POLYPS  1  1/424 (0.24%)  1
PLEURAL EFFUSION  1  1/424 (0.24%)  1
PNEUMOTHORAX  1  1/424 (0.24%)  1
PULMONARY EMBOLISM  1  1/424 (0.24%)  1
PULMONARY FIBROSIS  1  1/424 (0.24%)  1
SLEEP APNOEA SYNDROME  1  1/424 (0.24%)  1
Skin and subcutaneous tissue disorders   
INGROWING NAIL  1  1/424 (0.24%)  1
Vascular disorders   
AORTIC DILATATION  1  1/424 (0.24%)  1
BEHCET'S SYNDROME  1  1/424 (0.24%)  1
HYPERTENSION  1  1/424 (0.24%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab
Affected / at Risk (%) # Events
Total   332/424 (78.30%)    
Eye disorders   
CATARACT  1  30/424 (7.08%)  38
CYSTOID MACULAR OEDEMA  1  43/424 (10.14%)  70
DRY EYE  1  30/424 (7.08%)  33
EYE PAIN  1  25/424 (5.90%)  27
IRIDOCYCLITIS  1  22/424 (5.19%)  29
MACULAR OEDEMA  1  24/424 (5.66%)  31
UVEITIS  1  123/424 (29.01%)  217
VISUAL ACUITY REDUCED  1  30/424 (7.08%)  36
Gastrointestinal disorders   
DIARRHOEA  1  28/424 (6.60%)  33
NAUSEA  1  32/424 (7.55%)  45
General disorders   
FATIGUE  1  36/424 (8.49%)  42
PYREXIA  1  24/424 (5.66%)  28
Infections and infestations   
BRONCHITIS  1  38/424 (8.96%)  50
INFLUENZA  1  36/424 (8.49%)  44
NASOPHARYNGITIS  1  105/424 (24.76%)  214
SINUSITIS  1  33/424 (7.78%)  43
UPPER RESPIRATORY TRACT INFECTION  1  43/424 (10.14%)  65
URINARY TRACT INFECTION  1  47/424 (11.08%)  66
Investigations   
INTRAOCULAR PRESSURE INCREASED  1  23/424 (5.42%)  30
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  72/424 (16.98%)  94
BACK PAIN  1  26/424 (6.13%)  30
PAIN IN EXTREMITY  1  24/424 (5.66%)  25
Nervous system disorders   
HEADACHE  1  63/424 (14.86%)  83
Respiratory, thoracic and mediastinal disorders   
COUGH  1  42/424 (9.91%)  45
OROPHARYNGEAL PAIN  1  32/424 (7.55%)  39
Skin and subcutaneous tissue disorders   
RASH  1  24/424 (5.66%)  30
Vascular disorders   
HYPERTENSION  1  27/424 (6.37%)  28
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01148225    
Other Study ID Numbers: M11-327
2009-016196-29 ( EudraCT Number )
First Submitted: May 14, 2010
First Posted: June 22, 2010
Results First Submitted: February 1, 2019
Results First Posted: April 4, 2019
Last Update Posted: April 4, 2019