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Efficacy and Safety of Adalimumab in Patients With Active Uveitis (VISUAL l)

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: NCT01138657
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : August 22, 2016
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Uveitis
Interventions Biological: Adalimumab
Drug: Prednisone
Drug: Placebo
Enrollment 239
Recruitment Details This study includes a Japan sub-study. 239 participants with active non-infectious intermediate uveitis, posterior uveitis, or panuveitis were randomized worldwide, including 223 participants at 67 sites in Australia, Europe, Israel, Latin America, and North America (Main Study), and 16 participants randomized at 7 sites in Japan (Japan sub-study).
Pre-assignment Details

Participants were randomized in a 1:1 ratio double-masked fashion stratified by baseline immunosuppressant usage. Participants recruited in the Japan sub-study were randomized in a separate stratum with no stratification by baseline immunosuppressant usage.

Study completion was defined as meeting treatment failure or reaching study Week 80.
Arm/Group Title Placebo Adalimumab
Hide Arm/Group Description Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Period Title: Overall Study
Started 120 119
Enrolled in Main Study 112 111
Enrolled in Japan Sub-study 8 8
Completed 112 101
Not Completed 8 18
Reason Not Completed
Adverse Event             3             10
Lack of Efficacy             2             1
Lost to Follow-up             0             3
Miscellaneous Reasons             3             4
Arm/Group Title Placebo Adalimumab Total
Hide Arm/Group Description Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. Total of all reporting groups
Overall Number of Baseline Participants 120 119 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 119 participants 239 participants
43.19  (14.331) 43.46  (15.458) 43.33  (14.872)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 120 participants 119 participants 239 participants
< 40 years 56 47 103
40 - 64 years 54 56 110
≥ 65 years 10 16 26
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 119 participants 239 participants
Female
73
  60.8%
66
  55.5%
139
  58.2%
Male
47
  39.2%
53
  44.5%
100
  41.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 120 participants 119 participants 239 participants
White 91 89 180
Black 12 11 23
Asian 10 12 22
American Indian/Alaskan Native 1 0 1
Native Hawaiian or Other Pacific Islander 0 0 0
Other 5 6 11
Multi Race 1 1 2
Type of Uveitis  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 120 participants 119 participants 239 participants
Intermediate 24 25 49
Posterior 38 38 76
Panuveitis 58 56 114
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 120 participants 119 participants 239 participants
Idiopathic 50 40 90
Birdshot Choroidopathy 21 24 45
Multifocal Choroiditis And Panuveitis 5 8 13
Vogt Koyanagi Harada 14 12 26
Sarcoid 12 12 24
Behcet's 4 14 18
Other 14 9 23
Eye Affected  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 120 participants 119 participants 239 participants
Left 5 6 11
Right 4 7 11
Both 111 106 217
Duration of Uveitis  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 120 participants 119 participants 239 participants
58.56  (85.308) 41.18  (53.530) 49.90  (71.660)
1.Primary Outcome
Title Time to Treatment Failure on or After Week 6
Hide Description

Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:

  • New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline
  • Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade
  • Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.

Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan.
Time Frame From Baseline until end of study (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population which included all randomized participants; 6 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 107 110 115 118
Median (Inter-Quartile Range)
Unit of Measure: months
3.0
(1.5 to 5.6)
5.6 [1] 
(3.0 to NA)
3.0
(1.5 to 5.6)
4.8 [1] 
(2.8 to NA)
[1]
Not estimable due to the low number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.36 to 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.40 to 0.76
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
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;

Grade 4+ = > 50 cells.
Time Frame From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points (best state achieved prior to Week 6 and at least 1 post-week 6 value); last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 102 101 110 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Left Eye 0.59  (0.935) 0.35  (0.763) 0.56  (0.913) 0.35  (0.744)
Right Eye 0.69  (1.067) 0.36  (0.746) 0.65  (1.039) 0.36  (0.727)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.51 to -0.07
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.46 to -0.04
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
3.Secondary Outcome
Title Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description

Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (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 From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 103 101 111 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Left Eye 0.33  (0.666) 0.11  (0.559) 0.34  (0.675) 0.11  (0.547)
Right Eye 0.45  (0.781) 0.13  (0.648) 0.49  (0.815) 0.16  (0.648)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as factor adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.43 to -0.11
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.43 to -0.12
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
4.Secondary Outcome
Title Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart.
Time Frame From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 103 101 111 109
Mean (Standard Deviation)
Unit of Measure: logMAR
Left Eye 0.12  (0.169) 0.07  (0.160) 0.11  (0.179) 0.07  (0.164)
Right Eye 0.13  (0.320) 0.04  (0.143) 0.13  (0.328) 0.05  (0.145)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as factor adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.11 to -0.02
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.10 to -0.02
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
5.Secondary Outcome
Title Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6
Hide Description

Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.

OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out.
Time Frame From Baseline until the Final Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population with no macular edema at Baseline
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 45 55 47 57
Median (Inter-Quartile Range)
Unit of Measure: months
6.2 [1] 
(1.4 to NA)
11.1
(2.6 to 15.9)
3.7 [1] 
(1.4 to NA)
9.2
(2.7 to 15.9)
[1]
Could not be estimated due to the low number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.39 to 1.26
Estimation Comments The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.38 to 1.21
Estimation Comments The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.
6.Secondary Outcome
Title Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description Central retinal thickness was measured using optical coherence tomography and assessed by a central reader.
Time Frame Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 102 101 108 109
Mean (Standard Deviation)
Unit of Measure: percent change
Left eye (n=100, 100, 107, 108) 20.2  (52.01) 9.6  (29.76) 19.0  (50.57) 13.9  (53.95)
Right eye (n=102, 101, 108, 109) 22.0  (62.48) 8.2  (25.78) 21.7  (60.75) 14.5  (57.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and OCT machine as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -11.4
Confidence Interval (2-Sided) 95%
-20.9 to -1.8
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments [Not Specified]
Method Chi-squared, Corrected
Comments ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-17.7 to 7.5
Estimation Comments The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.
7.Secondary Outcome
Title Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description

The National Eye Institute 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.
Time Frame Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 102 101 110 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.50  (11.968) -1.30  (10.980) -5.34  (11.899) -1.68  (10.924)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 4.20
Confidence Interval (2-Sided) 95%
1.02 to 7.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 3.67
Confidence Interval (2-Sided) 95%
0.62 to 6.71
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description

The National Eye Institute 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 distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning.
Time Frame Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 102 101 110 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.64  (14.654) -3.77  (13.414) -5.72  (14.531) -4.42  (13.871)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 1.86
Confidence Interval (2-Sided) 95%
-2.03 to 5.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
-2.47 to 5.09
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description

The National Eye Institute 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 distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning.
Time Frame Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 102 101 110 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.09  (17.754) -2.97  (16.784) -7.65  (17.808) -3.52  (16.494)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 5.12
Confidence Interval (2-Sided) 95%
0.34 to 9.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 4.14
Confidence Interval (2-Sided) 95%
-0.45 to 8.72
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
Hide Description

The National Eye Institute 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 ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain.
Time Frame Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.
Arm/Group Title Main Study: Placebo Main Study: Adalimumab Integrated Study (Main + Japan Sub-study): Placebo Integrated Study (Main + Japan Sub-study): Adalimumab
Hide Arm/Group Description:
Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Overall Number of Participants Analyzed 102 101 110 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.62  (21.435) -2.60  (15.342) -12.39  (20.841) -3.56  (16.056)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Study: Placebo, Main Study: Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 10.02
Confidence Interval (2-Sided) 95%
4.86 to 15.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Integrated Study (Main + Japan Sub-study): Placebo, Integrated Study (Main + Japan Sub-study): Adalimumab
Comments The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments ANOVA with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 8.83
Confidence Interval (2-Sided) 95%
3.88 to 13.79
Estimation Comments [Not Specified]
Time Frame From the first study drug administration until 70 days following the last study drug administration or until rollover into the extension study. Median duration of treatment was 91 days in the placebo arm and 129 days in the adalimumab arm.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Adalimumab
Hide Arm/Group Description Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
All-Cause Mortality
Placebo Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   5/120 (4.17%)   16/119 (13.45%) 
Eye disorders     
ANGLE CLOSURE GLAUCOMA † 1  0/120 (0.00%)  1/119 (0.84%) 
Hepatobiliary disorders     
HEPATITIS ACUTE † 1  1/120 (0.83%)  0/119 (0.00%) 
Immune system disorders     
ANAPHYLACTIC REACTION † 1  0/120 (0.00%)  1/119 (0.84%) 
Infections and infestations     
GASTROENTERITIS VIRAL † 1  1/120 (0.83%)  0/119 (0.00%) 
PILONIDAL CYST † 1  0/120 (0.00%)  1/119 (0.84%) 
PNEUMONIA † 1  0/120 (0.00%)  1/119 (0.84%) 
PYELONEPHRITIS ACUTE † 1  1/120 (0.83%)  0/119 (0.00%) 
SEPSIS † 1  1/120 (0.83%)  0/119 (0.00%) 
TUBERCULOSIS † 1  0/120 (0.00%)  1/119 (0.84%) 
UPPER RESPIRATORY TRACT INFECTION † 1  0/120 (0.00%)  1/119 (0.84%) 
URINARY TRACT INFECTION † 1  0/120 (0.00%)  1/119 (0.84%) 
Injury, poisoning and procedural complications     
ACCIDENTAL OVERDOSE † 1  0/120 (0.00%)  1/119 (0.84%) 
LIGAMENT RUPTURE † 1  0/120 (0.00%)  1/119 (0.84%) 
TENDON RUPTURE † 1  0/120 (0.00%)  1/119 (0.84%) 
WRIST FRACTURE † 1  1/120 (0.83%)  0/119 (0.00%) 
Metabolism and nutrition disorders     
FLUID OVERLOAD † 1  0/120 (0.00%)  1/119 (0.84%) 
Musculoskeletal and connective tissue disorders     
LUPUS-LIKE SYNDROME † 1  0/120 (0.00%)  1/119 (0.84%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT † 1  0/120 (0.00%)  1/119 (0.84%) 
GLIOBLASTOMA MULTIFORME † 1  0/120 (0.00%)  1/119 (0.84%) 
Nervous system disorders     
DEMYELINATION † 1  0/120 (0.00%)  1/119 (0.84%) 
Renal and urinary disorders     
CALCULUS URETERIC † 1  0/120 (0.00%)  1/119 (0.84%) 
RENAL FAILURE CHRONIC † 1  0/120 (0.00%)  1/119 (0.84%) 
Skin and subcutaneous tissue disorders     
URTICARIA † 1  0/120 (0.00%)  1/119 (0.84%) 
Surgical and medical procedures     
ABORTION INDUCED † 1  1/120 (0.83%)  0/119 (0.00%) 
Vascular disorders     
NEOVASCULARISATION † 1  0/120 (0.00%)  1/119 (0.84%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   61/120 (50.83%)   71/119 (59.66%) 
Eye disorders     
CYSTOID MACULAR OEDEMA † 1  6/120 (5.00%)  3/119 (2.52%) 
EYE PAIN † 1  2/120 (1.67%)  9/119 (7.56%) 
UVEITIS † 1  8/120 (6.67%)  12/119 (10.08%) 
VISION BLURRED † 1  2/120 (1.67%)  8/119 (6.72%) 
Gastrointestinal disorders     
DRY MOUTH † 1  1/120 (0.83%)  6/119 (5.04%) 
NAUSEA † 1  7/120 (5.83%)  6/119 (5.04%) 
General disorders     
FATIGUE † 1  7/120 (5.83%)  12/119 (10.08%) 
Infections and infestations     
BRONCHITIS † 1  4/120 (3.33%)  7/119 (5.88%) 
INFLUENZA † 1  6/120 (5.00%)  1/119 (0.84%) 
NASOPHARYNGITIS † 1  11/120 (9.17%)  21/119 (17.65%) 
URINARY TRACT INFECTION † 1  0/120 (0.00%)  6/119 (5.04%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  12/120 (10.00%)  10/119 (8.40%) 
BACK PAIN † 1  3/120 (2.50%)  9/119 (7.56%) 
MUSCLE SPASMS † 1  4/120 (3.33%)  7/119 (5.88%) 
Nervous system disorders     
HEADACHE † 1  16/120 (13.33%)  13/119 (10.92%) 
PARAESTHESIA † 1  0/120 (0.00%)  6/119 (5.04%) 
Psychiatric disorders     
ANXIETY † 1  0/120 (0.00%)  6/119 (5.04%) 
INSOMNIA † 1  8/120 (6.67%)  9/119 (7.56%) 
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  4/120 (3.33%)  7/119 (5.88%) 
Skin and subcutaneous tissue disorders     
HYPERHIDROSIS † 1  3/120 (2.50%)  7/119 (5.88%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
[Not Specified]
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 (prior sponsor, Abbott)
Phone: 800-633-9110
Publications of Results:
Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01138657    
Other Study ID Numbers: M10-877
2009-016095-68 ( EudraCT Number )
First Submitted: May 14, 2010
First Posted: June 7, 2010
Results First Submitted: July 11, 2016
Results First Posted: August 22, 2016
Last Update Posted: July 7, 2021