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A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

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ClinicalTrials.gov Identifier: NCT02016482
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : February 13, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Nail Psoriasis
Plaque Psoriasis
Interventions Biological: Adalimumab
Other: Placebo
Enrollment 217

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA) 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51. Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period Title: Period A
Started 108 109
Completed 94 [1] 94 [2]
Not Completed 14 15
Reason Not Completed
Adverse Event             3             5
Withdrawal by Subject             3             4
Lost to Follow-up             3             3
Lack of Efficacy             2             1
Not Specified             3             0
Protocol Violation             0             1
Required Alternative/Prohibited Therapy             0             1
[1]
56 participants early escaped to the end of Period A and 38 continued to the end of Period A.
[2]
8 participants early escaped to the end of Period A and 86 continued to the end of Period A.
Period Title: Period B
Started 94 94
Completed 81 87
Not Completed 13 7
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             2             0
Lack of Efficacy             6             4
Not Specified             4             0
Required Alternative/Prohibited Therapy             0             2
Arm/Group Title Placebo Adalimumab EOW Total
Hide Arm/Group Description Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51. Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51. Total of all reporting groups
Overall Number of Baseline Participants 108 109 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 109 participants 217 participants
46.16  (12.134) 47.21  (11.858) 46.69  (11.980)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
< 40 years 34 30 64
40 to ≤ 64 years 65 70 135
≥ 65 years 9 9 18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Female
21
  19.4%
13
  11.9%
34
  15.7%
Male
87
  80.6%
96
  88.1%
183
  84.3%
1.Primary Outcome
Title Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26
Hide Description Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population in Period A: all participants who were randomized at Baseline.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
3.4 46.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments For US regulatory purposes, ranked first secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 43.2
Confidence Interval (2-Sided) 95%
32.8 to 53.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26
Hide Description The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of “clear” (0) or “minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
6.9 48.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 42.0
Confidence Interval (2-Sided) 95%
30.8 to 53.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26
Hide Description Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-11.5  (3.19) -56.2  (3.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -44.8
Confidence Interval (2-Sided) 95%
-53.5 to -36.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26
Hide Description Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
0.0 6.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.6
Confidence Interval (2-Sided) 95%
1.8 to 11.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26
Hide Description An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-1.1  (0.24) -3.7  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Percent Change
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-3.3 to -2.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
Hide Description Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.8  (0.24) -3.7  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-3.6 to -2.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26
Hide Description The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Scalp psoriasis was assessed by B-SNIPI at Week 26 for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 12 18
Measure Type: Number
Unit of Measure: percentage of participants
0.4 58.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 57.9
Confidence Interval (2-Sided) 95%
33.8 to 82.0
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26
Hide Description The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail bed component of "moderate" or "worse."
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail bed component of "moderate" or "worse." Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 101 98
Measure Type: Number
Unit of Measure: percentage of participants
8.2 51.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 43.3
Confidence Interval (2-Sided) 95%
31.3 to 55.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26
Hide Description The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail matrix component of "moderate" or "worse."
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail matrix component of "moderate" or "worse." Multiple imputations.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Unit of Measure: percentage of participants
8.5 53.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 44.8
Confidence Interval (2-Sided) 95%
33.2 to 56.5
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26
Hide Description The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
1.3 19.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.6
Confidence Interval (2-Sided) 95%
10.6 to 26.6
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26
Hide Description The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
7.3 43.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 36.0
Confidence Interval (2-Sided) 95%
25.0 to 46.9
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26
Hide Description Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
0.2 13.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.3
Confidence Interval (2-Sided) 95%
6.5 to 20.0
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Target Fingernail mNAPSI Score at Week 26
Hide Description The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.1  (0.27) -5.7  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-4.3 to -2.8
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26
Hide Description The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-23.0  (2.92) -61.9  (2.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -38.9
Confidence Interval (2-Sided) 95%
-46.9 to -30.8
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Total Fingernail mNAPSI Score at Week 26
Hide Description Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.5  (1.78) -36.1  (1.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -28.6
Confidence Interval (2-Sided) 95%
-33.5 to -23.7
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26
Hide Description Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-13.2  (3.06) -63.3  (3.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -50.1
Confidence Interval (2-Sided) 95%
-58.3 to -41.9
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26
Hide Description Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
0.0 7.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.4
Confidence Interval (2-Sided) 95%
2.4 to 12.4
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26
Hide Description The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
2.4 20.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 18.5
Confidence Interval (2-Sided) 95%
10.1 to 26.8
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Target Fingernail NAPSI Score at Week 26
Hide Description The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.1  (0.21) -3.6  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-3.1 to -1.9
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26
Hide Description The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-14.4  (3.50) -54.6  (3.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -40.2
Confidence Interval (2-Sided) 95%
-50.0 to -30.4
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Total Fingernail NAPSI Score at Week 26
Hide Description Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.7  (1.51) -26.2  (1.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -19.5
Confidence Interval (2-Sided) 95%
-23.6 to -15.3
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.9  (0.70) -9.0  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.1
Confidence Interval (2-Sided) 95%
-10.0 to -6.1
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percent Change From Baseline in PASI Score at Week 26
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.4  (5.77) -68.7  (5.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -71.2
Confidence Interval (2-Sided) 95%
-87.3 to -55.0
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline PASI score ≥ 5. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 95 97
Measure Type: Number
Unit of Measure: percentage of participants
PASI 75 13.8 64.8
PASI 50 25.3 77.8
PASI 90 7.1 48.0
PASI 100 2.9 29.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments PASI 75
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 51.1
Confidence Interval (2-Sided) 95%
38.6 to 63.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments PASI 50
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 52.5
Confidence Interval (2-Sided) 95%
39.9 to 65.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments PASI 90
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 40.9
Confidence Interval (2-Sided) 95%
29.0 to 52.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments PASI 100
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 26.4
Confidence Interval (2-Sided) 95%
15.8 to 36.9
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26
Hide Description The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
11.2 63.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 52.2
Confidence Interval (2-Sided) 95%
40.8 to 63.7
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Percentage of Participants Achieving PGA-S of "Clear" at Week 26
Hide Description The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) with at least a 2-grade improvement relative to Baseline at Week 26.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: percentage of participants
4.0 28.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.8
Confidence Interval (2-Sided) 95%
15.3 to 34.3
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26
Hide Description The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had Baseline inverse psoriasis score ≥ 6. Inverse psoriasis was assessed for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: percentage of participants
0.5 90.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 90.4
Confidence Interval (2-Sided) 95%
72.5 to 108.3
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Total Body Surface Area (BSA) at Week 26
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percentage of affected BSA
0.4  (1.00) -10.7  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.1
Confidence Interval (2-Sided) 95%
-13.9 to -8.4
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Percent Change From Baseline in Total BSA at Week 26
Hide Description BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
12.8  (6.08) -67.8  (6.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -80.6
Confidence Interval (2-Sided) 95%
-97.9 to -63.3
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26
Hide Description An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 103 103
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-18.0  (4.80) -68.9  (4.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -50.9
Confidence Interval (2-Sided) 95%
-64.0 to -37.8
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
Hide Description Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 105 104
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-9.9  (5.51) -67.6  (5.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -57.7
Confidence Interval (2-Sided) 95%
-73.1 to -42.4
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26
Hide Description Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.07) -1.3  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.1 to -0.7
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26
Hide Description Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-11.7  (2.24) -39.5  (2.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -27.7
Confidence Interval (2-Sided) 95%
-33.9 to -21.6
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26
Hide Description Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 93 94
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.9  (0.60) -8.0  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.1
Confidence Interval (2-Sided) 95%
-7.8 to -4.5
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26
Hide Description Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 93 94
Measure Type: Number
Unit of Measure: percentage of participants
DLQI = 0 2.5 18.2
DLQI = 0/1 3.7 30.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments DLQI = 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
7.1 to 24.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments DLQI = 0/1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 27.1
Confidence Interval (2-Sided) 95%
16.7 to 37.4
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26
Hide Description The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "fingernail psoriasis had no effect on this" and 10 indicating "fingernail psoriasis completely prevented me from this." A decrease in the WPAI:NPSO score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with given assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Absenteeism; n=65, 74 -1.0  (0.73) -0.3  (0.65)
Presenteeism; n=70, 77 -3.4  (2.08) -20.7  (2.06)
Overall Work impairment; n=65, 74 -6.2  (2.20) -21.3  (2.05)
Activity impairment; n=106, 108 -1.8  (2.09) -23.1  (2.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Absenteeism
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.0 to 2.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Presenteeism
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.3
Confidence Interval (2-Sided) 95%
-22.9 to -11.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Overall work impairment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.2
Confidence Interval (2-Sided) 95%
-21.0 to -9.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments Activity impairment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -21.4
Confidence Interval (2-Sided) 95%
-27.3 to -15.4
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26
Hide Description The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from –0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 107 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.01) 0.1  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.1 to 0.2
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26
Hide Description The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 107 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.1  (1.53) 5.5  (1.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
1.2 to 9.8
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26
Hide Description Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with a given assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
HADS anxiety score; n=106, 109 -0.1  (0.33) -1.1  (0.33)
HADS depression score; n=106, 108 0.0  (0.33) -1.4  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments HADS anxiety score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.0 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments HADS depression score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-2.3 to -0.4
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study
Hide Description The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.
Time Frame up to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and did not have PsA at Baseline. Observed cases.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 76 79
Measure Type: Number
Unit of Measure: percentage of participants
0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-0.9 to 6
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26
Hide Description Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.
Arm/Group Title Placebo Adalimumab EOW
Hide Arm/Group Description:
Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
Overall Number of Participants Analyzed 107 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.23) -3.3  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab EOW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-3.4 to -2.1
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from Baseline through Week 52 +70 day follow up phone call; serious adverse events were collected from Screening through Week 52 + 70 day follow up call.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Period A) Adalimumab EOW (Period A) Placebo/Adalimumab EOW (Period B) Adalimumab EOW/Adalimumab EOW (Period B)
Hide Arm/Group Description Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51. ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Following Period A (placebo sc eow for 25 weeks), ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51. Following Period A (ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg), placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
All-Cause Mortality
Placebo (Period A) Adalimumab EOW (Period A) Placebo/Adalimumab EOW (Period B) Adalimumab EOW/Adalimumab EOW (Period B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Period A) Adalimumab EOW (Period A) Placebo/Adalimumab EOW (Period B) Adalimumab EOW/Adalimumab EOW (Period B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/108 (4.63%)   8/109 (7.34%)   3/94 (3.19%)   3/94 (3.19%) 
Cardiac disorders         
ATRIAL FIBRILLATION  1  1/108 (0.93%)  0/109 (0.00%)  0/94 (0.00%)  0/94 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
MYOCARDIAL INFARCTION  1  0/108 (0.00%)  0/109 (0.00%)  1/94 (1.06%)  0/94 (0.00%) 
Gastrointestinal disorders         
DIVERTICULAR PERFORATION  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
Immune system disorders         
ANAPHYLACTIC REACTION  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
Infections and infestations         
BRONCHITIS  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
DIVERTICULITIS  1  0/108 (0.00%)  1/109 (0.92%)  1/94 (1.06%)  0/94 (0.00%) 
ENDOCARDITIS  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
ERYSIPELAS  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
INFLUENZA  1  0/108 (0.00%)  0/109 (0.00%)  0/94 (0.00%)  1/94 (1.06%) 
LUNG INFECTION  1  0/108 (0.00%)  0/109 (0.00%)  1/94 (1.06%)  0/94 (0.00%) 
PNEUMONIA  1  2/108 (1.85%)  0/109 (0.00%)  0/94 (0.00%)  1/94 (1.06%) 
Injury, poisoning and procedural complications         
ARTHROPOD STING  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders         
TENOSYNOVITIS  1  0/108 (0.00%)  0/109 (0.00%)  0/94 (0.00%)  1/94 (1.06%) 
Nervous system disorders         
CAROTID ARTERY STENOSIS  1  1/108 (0.93%)  0/109 (0.00%)  0/94 (0.00%)  0/94 (0.00%) 
SEIZURE  1  0/108 (0.00%)  0/109 (0.00%)  0/94 (0.00%)  1/94 (1.06%) 
Psychiatric disorders         
MAJOR DEPRESSION  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
SUICIDAL IDEATION  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
Renal and urinary disorders         
BLADDER SPHINCTER ATONY  1  0/108 (0.00%)  0/109 (0.00%)  0/94 (0.00%)  1/94 (1.06%) 
STRESS URINARY INCONTINENCE  1  0/108 (0.00%)  0/109 (0.00%)  0/94 (0.00%)  1/94 (1.06%) 
Reproductive system and breast disorders         
PROSTATITIS  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
BRONCHOSPASM  1  1/108 (0.93%)  0/109 (0.00%)  0/94 (0.00%)  0/94 (0.00%) 
Skin and subcutaneous tissue disorders         
PSORIASIS  1  1/108 (0.93%)  0/109 (0.00%)  0/94 (0.00%)  0/94 (0.00%) 
Vascular disorders         
HYPERTENSIVE CRISIS  1  0/108 (0.00%)  1/109 (0.92%)  0/94 (0.00%)  0/94 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Period A) Adalimumab EOW (Period A) Placebo/Adalimumab EOW (Period B) Adalimumab EOW/Adalimumab EOW (Period B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/108 (39.81%)   45/109 (41.28%)   28/94 (29.79%)   34/94 (36.17%) 
Gastrointestinal disorders         
DIARRHOEA  1  2/108 (1.85%)  3/109 (2.75%)  1/94 (1.06%)  2/94 (2.13%) 
TOOTHACHE  1  0/108 (0.00%)  0/109 (0.00%)  0/94 (0.00%)  3/94 (3.19%) 
General disorders         
INFLUENZA LIKE ILLNESS  1  0/108 (0.00%)  1/109 (0.92%)  2/94 (2.13%)  0/94 (0.00%) 
INJECTION SITE ERYTHEMA  1  0/108 (0.00%)  3/109 (2.75%)  0/94 (0.00%)  0/94 (0.00%) 
INJECTION SITE PAIN  1  2/108 (1.85%)  1/109 (0.92%)  2/94 (2.13%)  1/94 (1.06%) 
Infections and infestations         
BRONCHITIS  1  0/108 (0.00%)  2/109 (1.83%)  3/94 (3.19%)  2/94 (2.13%) 
GASTROENTERITIS  1  1/108 (0.93%)  4/109 (3.67%)  3/94 (3.19%)  2/94 (2.13%) 
NASOPHARYNGITIS  1  10/108 (9.26%)  6/109 (5.50%)  9/94 (9.57%)  12/94 (12.77%) 
UPPER RESPIRATORY TRACT INFECTION  1  9/108 (8.33%)  9/109 (8.26%)  6/94 (6.38%)  4/94 (4.26%) 
URINARY TRACT INFECTION  1  1/108 (0.93%)  1/109 (0.92%)  2/94 (2.13%)  1/94 (1.06%) 
Injury, poisoning and procedural complications         
LACERATION  1  0/108 (0.00%)  3/109 (2.75%)  0/94 (0.00%)  0/94 (0.00%) 
Investigations         
ALANINE AMINOTRANSFERASE INCREASED  1  2/108 (1.85%)  0/109 (0.00%)  0/94 (0.00%)  2/94 (2.13%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/108 (1.85%)  0/109 (0.00%)  1/94 (1.06%)  2/94 (2.13%) 
BLOOD TRIGLYCERIDES INCREASED  1  3/108 (2.78%)  0/109 (0.00%)  1/94 (1.06%)  1/94 (1.06%) 
Metabolism and nutrition disorders         
HYPERLIPIDAEMIA  1  0/108 (0.00%)  3/109 (2.75%)  0/94 (0.00%)  1/94 (1.06%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  4/108 (3.70%)  5/109 (4.59%)  0/94 (0.00%)  1/94 (1.06%) 
BACK PAIN  1  4/108 (3.70%)  2/109 (1.83%)  1/94 (1.06%)  2/94 (2.13%) 
PSORIATIC ARTHROPATHY  1  1/108 (0.93%)  2/109 (1.83%)  0/94 (0.00%)  2/94 (2.13%) 
Nervous system disorders         
HEADACHE  1  0/108 (0.00%)  6/109 (5.50%)  2/94 (2.13%)  1/94 (1.06%) 
Psychiatric disorders         
DEPRESSION  1  1/108 (0.93%)  1/109 (0.92%)  0/94 (0.00%)  3/94 (3.19%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  3/108 (2.78%)  2/109 (1.83%)  1/94 (1.06%)  0/94 (0.00%) 
OROPHARYNGEAL PAIN  1  3/108 (2.78%)  2/109 (1.83%)  1/94 (1.06%)  1/94 (1.06%) 
Skin and subcutaneous tissue disorders         
DERMATITIS CONTACT  1  0/108 (0.00%)  3/109 (2.75%)  0/94 (0.00%)  1/94 (1.06%) 
PSORIASIS  1  6/108 (5.56%)  1/109 (0.92%)  4/94 (4.26%)  1/94 (1.06%) 
Vascular disorders         
HYPERTENSION  1  2/108 (1.85%)  4/109 (3.67%)  0/94 (0.00%)  1/94 (1.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Due to study design, a high percentage of participants randomized to the placebo arm early escaped from Period A and thus participated for a shorter duration than did participants in the active treatment arm.
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
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02016482     History of Changes
Other Study ID Numbers: M13-674
2013-003275-36 ( EudraCT Number )
First Submitted: December 16, 2013
First Posted: December 20, 2013
Results First Submitted: October 21, 2016
Results First Posted: February 13, 2017
Last Update Posted: May 30, 2017