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Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (Visual II)

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ClinicalTrials.gov Identifier: NCT01124838
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : June 21, 2016
Last Update Posted : August 11, 2016
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 Drug: Adalimumab
Drug: Prednisone
Drug: Placebo
Enrollment 261
Recruitment Details This study includes a Japan sub-study. A total of 261 adults with inactive non-infectious intermediate uveitis, posterior uveitis or panuveitis were randomized at 72 study sites worldwide; 229 participants at 62 study sites in Australia, Israel, Latin America, North America, and Europe (Main Study), and 32 participants at 10 study sites in Japan.
Pre-assignment Details

Participants were randomized in a 1:1 ratio double-masked fashion using baseline immunosuppressant (IMM) usage as the stratification factor. Participants in the Japan sub-study were randomized in a separate stratum with no stratification by baseline IMM usage.

Study completion is 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, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19. 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Period Title: Overall Study
Started 130 131
Enrolled in Main Study 114 115
Enrolled in Japan Sub-study 16 16
Completed 112 116
Not Completed 18 15
Reason Not Completed
Miscellaneous             4             2
Adverse Event             7             11
Lack of Efficacy             2             0
Withdrawal by Subject             3             2
Lost to Follow-up             2             0
Arm/Group Title Placebo Adalimumab Total
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, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19. 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19. Total of all reporting groups
Overall Number of Baseline Participants 130 131 261
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 131 participants 261 participants
43.22  (14.026) 43.18  (12.719) 43.20  (13.360)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
< 65 years 121 125 246
≥ 65 years 9 6 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
Female
83
  63.8%
75
  57.3%
158
  60.5%
Male
47
  36.2%
56
  42.7%
103
  39.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
White 96 96 192
Black 8 6 14
Asian 19 19 38
American Indian/Alaskan Native 1 0 1
Native Hawaiian or Other Pacific Islander 0 0 0
Other 5 9 14
Multi-Race 1 1 2
Type of Uveitis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
Intermediate 30 17 47
Posterior 36 41 77
Panuveitis 63 71 134
Intermediate/Posterior 1 2 3
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
Idiopathic 45 33 78
Birdshot Choroidopathy 16 15 31
Multifocal Choroiditis and Panuveitis 2 5 7
Vogt Koyanagi Harada 30 34 64
Sarcoid 20 22 42
Behcet's 7 10 17
Other 10 12 22
Eye Affected  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
Left 3 3 6
Right 5 2 7
Both 122 126 248
History of Infectious Uveitis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 131 participants 261 participants
Yes 0 0 0
No 130 131 261
Duration of Uveitis  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 130 participants 131 participants 261 participants
59.36  (64.753) 58.35  (61.834) 58.85  (63.185)
1.Primary Outcome
Title Time to Treatment Failure on or After Week 2
Hide Description

Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:

  • New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline
  • 2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade
  • Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.

Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.

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; 3 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 111 115 127 131
Median (Inter-Quartile Range)
Unit of Measure: months
8.3 [1] 
(3.0 to NA)
NA [1] 
(4.7 to NA)
5.6 [1] 
(2.6 to NA)
NA [1] 
(3.9 to NA)
[1]
Not estimable due to the low number of events
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.39 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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
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 0.52
Confidence Interval (2-Sided) 95%
0.37 to 0.74
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline 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 Baseline and at the Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 110 115 126 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Left eye 0.57  (1.001) 0.41  (0.969) 0.61  (1.005) 0.46  (0.996)
Right eye 0.53  (0.963) 0.40  (0.927) 0.60  (0.992) 0.44  (0.950)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANOVA
Comments From 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 -0.14
Confidence Interval (2-Sided) 95%
-0.37 to 0.08
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.
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.36 to 0.06
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 Baseline 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 Baseline and Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 110 115 126 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Left eye 0.33  (0.733) 0.16  (0.601) 0.35  (0.749) 0.18  (0.614)
Right eye 0.27  (0.605) 0.18  (0.604) 0.36  (0.729) 0.18  (0.602)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment as factor
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.28 to 0.01
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.
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.31 to -0.03
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 Baseline 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. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Time Frame Baseline and Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 110 115 126 131
Mean (Standard Deviation)
Unit of Measure: logMAR
Left eye 0.06  (0.239) 0.01  (0.251) 0.07  (0.230) 0.02  (0.241)
Right eye 0.02  (0.198) -0.01  (0.165) 0.04  (0.216) 0.00  (0.169)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.08 to 0.01
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.
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method ANOVA
Comments From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.09 to 0.00
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 Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2
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 2 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 95 90 106 102
Median (Inter-Quartile Range)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Could not be estimated due to the low number of events
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.491
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.34 to 1.69
Estimation Comments The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.28 to 1.28
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 Baseline to the Final/Early Termination Visit.
Hide Description Central retinal thickness was measured using OCT and assessed by a central reader.
Time Frame Baseline and Final/Early Termination Visit (up to 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 108 114 124 130
Mean (Standard Deviation)
Unit of Measure: percent change
Left eye (N = 107, 114, 122, 130) 6.4  (20.67) 4.5  (29.82) 6.3  (19.75) 5.2  (29.91)
Right eye (N = 108, 113, 124, 129) 7.7  (28.88) 5.4  (34.83) 9.9  (30.79) 3.9  (33.34)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-8.5 to 3.8
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.
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method ANOVA
Comments From 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 -3.9
Confidence Interval (2-Sided) 95%
-9.7 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.
7.Secondary Outcome
Title Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline 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 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 109 115 125 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.24  (10.698) 3.36  (11.73) 1.00  (10.225) 2.79  (12.018)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 2.12
Confidence Interval (2-Sided) 95%
-0.84 to 5.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
-0.97 to 4.52
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in VFQ-25 Subscore Distance Vision From Baseline 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 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 109 115 125 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.76  (16.248) 2.64  (17.165) 0.60  (15.978) 2.96  (17.121)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
-2.53 to 6.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
-1.73 to 6.45
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in VFQ-25 Subscore Near Vision From Baseline 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 near 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 and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 109 115 125 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.98  (17.397) 3.88  (18.302) 3.73  (17.17) 2.89  (50.503)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.967
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment as a factor.
Method of Estimation Estimation Parameter Mena Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-4.81 to 4.61
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-5.53 to 3.79
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in VFQ-25 Subscore Ocular Pain From Baseline 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 form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain.

Time Frame Baseline and Final/Early Termination Visit (up 80 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Participants, excluding those enrolled in the Japan sub-study, 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
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 eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Overall Number of Participants Analyzed 109 115 125 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.87  (17.233) 3.42  (21.32) 2.60  (17.339) 2.15  (21.689)
Show Statistical Analysis 1 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.830
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment as a factor.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-4.56 to 5.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method ANOVA
Comments From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-5.32 to 4.34
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 147 days in the placebo arm and 245 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 every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19. 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, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
All-Cause Mortality
Placebo Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   10/130 (7.69%)   8/131 (6.11%) 
Blood and lymphatic system disorders     
NEUTROPENIA  1  0/130 (0.00%)  1/131 (0.76%) 
Cardiac disorders     
CARDIAC TAMPONADE  1  0/130 (0.00%)  1/131 (0.76%) 
Eye disorders     
BLINDNESS TRANSIENT  1  0/130 (0.00%)  1/131 (0.76%) 
CHOROIDAL NEOVASCULARISATION  1  1/130 (0.77%)  0/131 (0.00%) 
RETINAL DETACHMENT  1  1/130 (0.77%)  0/131 (0.00%) 
SUBRETINAL FLUID  1  1/130 (0.77%)  0/131 (0.00%) 
Gastrointestinal disorders     
DYSPHAGIA  1  0/130 (0.00%)  1/131 (0.76%) 
Infections and infestations     
BRONCHITIS  1  0/130 (0.00%)  1/131 (0.76%) 
MENINGITIS ASEPTIC  1  1/130 (0.77%)  0/131 (0.00%) 
PNEUMONIA  1  0/130 (0.00%)  1/131 (0.76%) 
PNEUMONIA LEGIONELLA  1  0/130 (0.00%)  1/131 (0.76%) 
TONSILLITIS  1  1/130 (0.77%)  0/131 (0.00%) 
Injury, poisoning and procedural complications     
FIBULA FRACTURE  1  0/130 (0.00%)  1/131 (0.76%) 
HUMERUS FRACTURE  1  1/130 (0.77%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRITIS  1  1/130 (0.77%)  0/131 (0.00%) 
OSTEONECROSIS  1  1/130 (0.77%)  0/131 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
LUNG ADENOCARCINOMA STAGE IV  1  0/130 (0.00%)  1/131 (0.76%) 
Nervous system disorders     
DYSARTHRIA  1  0/130 (0.00%)  1/131 (0.76%) 
STATUS MIGRAINOSUS  1  0/130 (0.00%)  1/131 (0.76%) 
Respiratory, thoracic and mediastinal disorders     
EPISTAXIS  1  0/130 (0.00%)  1/131 (0.76%) 
PLEURISY  1  0/130 (0.00%)  1/131 (0.76%) 
Vascular disorders     
AORTIC DISSECTION  1  0/130 (0.00%)  1/131 (0.76%) 
DEEP VEIN THROMBOSIS  1  2/130 (1.54%)  0/131 (0.00%) 
HYPERTENSIVE CRISIS  1  1/130 (0.77%)  0/131 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   78/130 (60.00%)   88/131 (67.18%) 
Eye disorders     
CYSTOID MACULAR OEDEMA  1  7/130 (5.38%)  7/131 (5.34%) 
DRY EYE  1  8/130 (6.15%)  5/131 (3.82%) 
EYE PAIN  1  6/130 (4.62%)  9/131 (6.87%) 
UVEITIS  1  9/130 (6.92%)  6/131 (4.58%) 
VISUAL ACUITY REDUCED  1  10/130 (7.69%)  6/131 (4.58%) 
Gastrointestinal disorders     
DIARRHOEA  1  9/130 (6.92%)  4/131 (3.05%) 
NAUSEA  1  9/130 (6.92%)  4/131 (3.05%) 
General disorders     
FATIGUE  1  9/130 (6.92%)  14/131 (10.69%) 
INJECTION SITE PAIN  1  9/130 (6.92%)  8/131 (6.11%) 
PYREXIA  1  8/130 (6.15%)  6/131 (4.58%) 
Infections and infestations     
INFLUENZA  1  7/130 (5.38%)  3/131 (2.29%) 
NASOPHARYNGITIS  1  20/130 (15.38%)  23/131 (17.56%) 
SINUSITIS  1  4/130 (3.08%)  8/131 (6.11%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/130 (2.31%)  10/131 (7.63%) 
URINARY TRACT INFECTION  1  11/130 (8.46%)  13/131 (9.92%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/130 (0.77%)  9/131 (6.87%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/130 (0.77%)  8/131 (6.11%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  12/130 (9.23%)  28/131 (21.37%) 
BACK PAIN  1  7/130 (5.38%)  10/131 (7.63%) 
PAIN IN EXTREMITY  1  3/130 (2.31%)  10/131 (7.63%) 
Nervous system disorders     
HEADACHE  1  17/130 (13.08%)  17/131 (12.98%) 
Psychiatric disorders     
INSOMNIA  1  3/130 (2.31%)  9/131 (6.87%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  6/130 (4.62%)  11/131 (8.40%) 
Vascular disorders     
HYPERTENSION  1  5/130 (3.85%)  7/131 (5.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01124838     History of Changes
Other Study ID Numbers: M10-880
2009-016008-22 ( EudraCT Number )
First Submitted: May 14, 2010
First Posted: May 17, 2010
Results First Submitted: May 13, 2016
Results First Posted: June 21, 2016
Last Update Posted: August 11, 2016