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A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

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ClinicalTrials.gov Identifier: NCT01483599
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: CNTO 1959 (5 mg)
Drug: CNTO 1959 (15 mg)
Drug: CNTO 1959 (50 mg)
Drug: CNTO 1959 (100 mg)
Drug: CNTO 1959 (200 mg)
Drug: Adalimumab
Drug: Placebo
Enrollment 293
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (CP) CNTO1959 5 mg (CP) CNTO1959 15 mg (CP) CNTO1959 50 mg (CP) CNTO1959 100 mg (CP) CNTO1959 200 mg (CP) Adalimumab (CP) Placebo -> 100 mg CNTO1959 (After CP) CNTO1959 5 mg (After CP) CNTO1959 15 mg (After CP) CNTO1959 50 mg (After CP) CNTO1959 100 mg (After CP) CNTO1959 200 mg (After CP) Adalimumab (After CP)
Hide Arm/Group Description Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8. Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8. Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4. Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8. Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4. Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8. Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15. Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40. Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40. Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40. Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40. Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40. Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40. Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
Period Title: Controlled Period (CP) (up to Week 16)
Started 42 41 41 42 42 42 43 0 0 0 0 0 0 0
Treated 42 41 41 42 42 41 43 0 0 0 0 0 0 0
Completed 39 38 41 39 40 38 39 0 0 0 0 0 0 0
Not Completed 3 3 0 3 2 4 4 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             2             0             0             1             1             4             3             0             0             0             0             0             0             0
Lost to Follow-up             0             1             0             1             0             0             1             0             0             0             0             0             0             0
Lack of Efficacy             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Other             0             2             0             1             1             0             0             0             0             0             0             0             0             0
Period Title: After Controlled Period(Week 16-Week 40)
Started 0 0 0 0 0 0 0 39 38 41 39 40 38 39
Completed 0 0 0 0 0 0 0 37 29 37 37 39 35 32
Not Completed 0 0 0 0 0 0 0 2 9 4 2 1 3 7
Reason Not Completed
Death             0             0             0             0             0             0             0             0             1             0             0             0             0             0
Adverse Event             0             0             0             0             0             0             0             1             1             0             0             0             1             1
Lost to Follow-up             0             0             0             0             0             0             0             0             1             0             0             1             0             1
Withdrawal by Subject             0             0             0             0             0             0             0             0             1             0             2             0             0             1
Lack of Efficacy             0             0             0             0             0             0             0             0             5             0             0             0             1             4
Other             0             0             0             0             0             0             0             1             0             4             0             0             1             0
Arm/Group Title Placebo CNTO1959 5 mg CNTO1959 15 mg CNTO1959 50 mg CNTO1959 100 mg CNTO1959 200 mg Adalimumab Total
Hide Arm/Group Description Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40. Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40. Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40. Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40. Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40. Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40. Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39. Total of all reporting groups
Overall Number of Baseline Participants 42 41 41 42 42 42 43 293
Hide Baseline Analysis Population Description
Population analyzed included all participants who were randomized.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 42 participants 42 participants 42 participants 43 participants 293 participants
<=18 years
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Between 18 and 65 years
41
  97.6%
39
  95.1%
39
  95.1%
41
  97.6%
36
  85.7%
40
  95.2%
35
  81.4%
271
  92.5%
>=65 years
1
   2.4%
1
   2.4%
2
   4.9%
1
   2.4%
6
  14.3%
2
   4.8%
8
  18.6%
21
   7.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 41 participants 41 participants 42 participants 42 participants 42 participants 43 participants 293 participants
45  (11.97) 45.2  (13.92) 43.8  (13.5) 42.6  (12.14) 45.3  (13.72) 45.1  (10.96) 47.5  (14.91) 44.9  (13.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 42 participants 42 participants 42 participants 43 participants 293 participants
Female
14
  33.3%
13
  31.7%
13
  31.7%
12
  28.6%
10
  23.8%
11
  26.2%
13
  30.2%
86
  29.4%
Male
28
  66.7%
28
  68.3%
28
  68.3%
30
  71.4%
32
  76.2%
31
  73.8%
30
  69.8%
207
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 42 participants 42 participants 42 participants 43 participants 293 participants
Germany 2 2 4 5 4 3 3 23
Belgium 2 1 0 0 1 1 0 5
Poland 7 8 7 10 7 8 8 55
Canada 13 11 11 11 12 14 11 83
United States 18 19 19 16 18 16 21 127
1.Primary Outcome
Title Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16
Hide Description PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all participants who were randomized.
Arm/Group Title Placebo CNTO1959 5 mg CNTO1959 15 mg CNTO1959 50 mg CNTO1959 100 mg CNTO1959 200 mg Adalimumab
Hide Arm/Group Description:
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
Overall Number of Participants Analyzed 42 41 41 42 42 42 43
Measure Type: Number
Unit of Measure: percentage of participants
7.1 34.1 61.0 78.6 85.7 83.3 58.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 5 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (<=) 90 kilogram (kg), greater than (>) 90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 15 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 100 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all participants who were randomized.
Arm/Group Title Placebo CNTO1959 5 mg CNTO1959 15 mg CNTO1959 50 mg CNTO1959 100 mg CNTO1959 200 mg Adalimumab
Hide Arm/Group Description:
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
Overall Number of Participants Analyzed 42 41 41 42 42 42 43
Measure Type: Number
Unit of Measure: percentage of participants
4.8 43.9 75.6 81.0 78.6 81.0 69.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 5 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 15 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 100 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
3.Secondary Outcome
Title Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16
Hide Description PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all participants who were randomized.
Arm/Group Title CNTO1959 5 mg CNTO1959 15 mg CNTO1959 50 mg CNTO1959 100 mg CNTO1959 200 mg Adalimumab
Hide Arm/Group Description:
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
Overall Number of Participants Analyzed 41 41 42 42 42 43
Measure Type: Number
Unit of Measure: percentage of participants
34.1 61.0 78.6 85.7 83.3 58.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CNTO1959 5 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -24.0
Confidence Interval (2-Sided) 95%
-44.0 to -4.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CNTO1959 15 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-17.9 to 23.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CNTO1959 50 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.4
Confidence Interval (2-Sided) 95%
1.5 to 39.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CNTO1959 100 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 27.7
Confidence Interval (2-Sided) 95%
9.8 to 45.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CNTO1959 200 mg, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.4
Confidence Interval (2-Sided) 95%
7.2 to 43.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40
Hide Description PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).
Time Frame Week 40
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.
Arm/Group Title CNTO1959 5 mg CNTO1959 15 mg CNTO1959 50 mg CNTO1959 100 mg CNTO1959 200 mg Adalimumab
Hide Arm/Group Description:
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
Overall Number of Participants Analyzed 34 37 38 39 37 37
Measure Type: Number
Unit of Measure: percentage of participants
35.3 59.5 71.1 76.9 81.1 48.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CNTO1959 5 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -15.4
Confidence Interval (2-Sided) 95%
-37.7 to 6.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CNTO1959 15 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-10.7 to 32.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CNTO1959 50 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
1.8 to 43.6
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CNTO1959 100 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 28.7
Confidence Interval (2-Sided) 95%
8.5 to 49.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CNTO1959 200 mg, Adalimumab
Comments The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 32.9
Confidence Interval (2-Sided) 95%
13.0 to 52.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Hide Description The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo CNTO1959 5 mg CNTO1959 15 mg CNTO1959 50 mg CNTO1959 100 mg CNTO1959 200 mg Adalimumab
Hide Arm/Group Description:
Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4, Week 8 then 100 mg CNTO1959 at Week 16 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 15 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 50 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received CNTO1959 100 mg subcutaneous injection at Week 0, Week 8 and once every 8 weeks thereafter through Week 40.
Participants received CNTO1959 200 mg subcutaneous injection at Week 0, Week 4 and once every 12 weeks thereafter through Week 40.
Participants received Adalimumab 80 mg subcutaneous injection at Week 0, 40 mg at Week 1 and once every other week thereafter through Week 39.
Overall Number of Participants Analyzed 42 39 41 40 40 39 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3  (6.80) -6.2  (5.24) -10.3  (5.49) -11.1  (7.38) -10.8  (7.34) -11.4  (6.83) -10.1  (9.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANOVA on the van Der Waerden score
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA on the van Der Waerden score
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA on the van Der Waerden score
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA on the van Der Waerden score
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA on the van Der Waerden score
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA on the van Der Waerden score
Comments [Not Specified]
Time Frame Baseline (Week 0) up to Week 52
Adverse Event Reporting Description Safety analysis set included all randomized participants who received at least 1 injection of study treatment (partial or complete).
 
Arm/Group Title Placebo (CP) CNTO1959 5 mg (CP) CNTO1959 15 mg (CP) CNTO1959 50 mg (CP) CNTO1959 100 mg (CP) CNTO1959 200 mg (CP) Adalimumab (CP) Placebo -> 100 mg CNTO1959 (After CP) CNTO1959 5 mg (After CP) CNTO1959 15 mg (After CP) CNTO1959 50 mg (After CP) CNTO1959 100 mg (After CP) CNTO1959 200 mg (After CP) Adalimumab (After CP)
Hide Arm/Group Description Participants received placebo matched to CNTO1959 subcutaneous injection at Week 0, Week 4 and Week 8. Participants received CNTO1959 5 milligram (mg) subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8. Participants received CNTO1959 15 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4. Participants received CNTO1959 50 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8. Participants received CNTO1959 100 mg subcutaneous injection at Week 0 and Week 8 and matching placebo subcutaneous injection at Week 4. Participants received CNTO1959 200 mg subcutaneous injection at Week 0 and Week 4 and matching placebo subcutaneous injection at Week 8. Participants received Adalimumab 80 mg subcutaneous injection at Week 0 and 40 mg at Week 1 and every other week up to Week 15. Same participants who received placebo and completed controlled period transitioned to receive 100 mg CNTO1959 at Week 16 and once in every 8 weeks through Week 40. Participants who received CNTO1959 5 mg and completed controlled period continued to receive CNTO1959 5 mg starting at Week 16 and once in every 12 weeks through Week 40. Participants who received CNTO1959 15 mg and completed controlled period continued to receive CNTO1959 15 mg starting at Week 16 and once in every 8 weeks through Week 40. Participants who received CNTO1959 50 mg and completed controlled period continued to receive CNTO1959 50 mg starting at Week 16 and once in every 12 weeks through Week 40. Participants who received CNTO1959 100 mg and completed controlled period continued to receive CNTO1959 100 mg starting at Week 16 and once in every 8 weeks through Week 40. Participants who received CNTO1959 200 mg and completed controlled period continued to receive CNTO1959 200 mg starting at Week 16 and once in every 12 weeks through Week 40. Participants who received adalimumab and completed controlled period continued to receive adalimumab 40 mg starting at week 17 and every other week thereafter through Week 39.
All-Cause Mortality
Placebo (CP) CNTO1959 5 mg (CP) CNTO1959 15 mg (CP) CNTO1959 50 mg (CP) CNTO1959 100 mg (CP) CNTO1959 200 mg (CP) Adalimumab (CP) Placebo -> 100 mg CNTO1959 (After CP) CNTO1959 5 mg (After CP) CNTO1959 15 mg (After CP) CNTO1959 50 mg (After CP) CNTO1959 100 mg (After CP) CNTO1959 200 mg (After CP) Adalimumab (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (CP) CNTO1959 5 mg (CP) CNTO1959 15 mg (CP) CNTO1959 50 mg (CP) CNTO1959 100 mg (CP) CNTO1959 200 mg (CP) Adalimumab (CP) Placebo -> 100 mg CNTO1959 (After CP) CNTO1959 5 mg (After CP) CNTO1959 15 mg (After CP) CNTO1959 50 mg (After CP) CNTO1959 100 mg (After CP) CNTO1959 200 mg (After CP) Adalimumab (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/42 (2.38%)   0/41 (0.00%)   0/41 (0.00%)   3/42 (7.14%)   0/42 (0.00%)   0/41 (0.00%)   1/43 (2.33%)   0/39 (0.00%)   2/38 (5.26%)   0/41 (0.00%)   0/39 (0.00%)   2/40 (5.00%)   0/38 (0.00%)   1/38 (2.63%) 
Cardiac disorders                             
Atrial Flutter * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/43 (2.33%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Myocardial Infarction * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/41 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/38 (0.00%) 
Gastrointestinal disorders                             
Oesophagitis Haemorrhagic * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  1/38 (2.63%) 
Umbilical Hernia * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Infections and infestations                             
Appendicitis * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Lung Abscess * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Pneumonia * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  1/38 (2.63%) 
Metabolism and nutrition disorders                             
Hyperglycaemia * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorders                             
Osteoarthritis * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Nervous system disorders                             
Cerebrovascular Accident * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/38 (0.00%) 
Reproductive system and breast disorders                             
Uterine Prolapse * 1  1/42 (2.38%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Vascular disorders                             
Haematoma * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/43 (2.33%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (CP) CNTO1959 5 mg (CP) CNTO1959 15 mg (CP) CNTO1959 50 mg (CP) CNTO1959 100 mg (CP) CNTO1959 200 mg (CP) Adalimumab (CP) Placebo -> 100 mg CNTO1959 (After CP) CNTO1959 5 mg (After CP) CNTO1959 15 mg (After CP) CNTO1959 50 mg (After CP) CNTO1959 100 mg (After CP) CNTO1959 200 mg (After CP) Adalimumab (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/42 (30.95%)   15/41 (36.59%)   10/41 (24.39%)   10/42 (23.81%)   7/42 (16.67%)   8/41 (19.51%)   10/43 (23.26%)   16/39 (41.03%)   12/38 (31.58%)   4/41 (9.76%)   11/39 (28.21%)   16/40 (40.00%)   12/38 (31.58%)   13/38 (34.21%) 
General disorders                             
Fatigue * 1  3/42 (7.14%)  1/41 (2.44%)  1/41 (2.44%)  2/42 (4.76%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/38 (2.63%)  0/38 (0.00%) 
Influenza Like Illness * 1  0/42 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  2/38 (5.26%) 
Injection Site Erythema * 1  1/42 (2.38%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  1/41 (2.44%)  5/43 (11.63%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  2/38 (5.26%) 
Infections and infestations                             
Gastroenteritis * 1  0/42 (0.00%)  1/41 (2.44%)  1/41 (2.44%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  2/39 (5.13%)  1/38 (2.63%)  0/41 (0.00%)  0/39 (0.00%)  2/40 (5.00%)  1/38 (2.63%)  1/38 (2.63%) 
Influenza * 1  0/42 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  2/40 (5.00%)  1/38 (2.63%)  1/38 (2.63%) 
Nasopharyngitis * 1  1/42 (2.38%)  6/41 (14.63%)  4/41 (9.76%)  1/42 (2.38%)  1/42 (2.38%)  2/41 (4.88%)  2/43 (4.65%)  4/39 (10.26%)  6/38 (15.79%)  1/41 (2.44%)  7/39 (17.95%)  4/40 (10.00%)  5/38 (13.16%)  6/38 (15.79%) 
Sinusitis * 1  1/42 (2.38%)  0/41 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  2/42 (4.76%)  0/41 (0.00%)  0/43 (0.00%)  2/39 (5.13%)  1/38 (2.63%)  1/41 (2.44%)  1/39 (2.56%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
Upper Respiratory Tract Infection * 1  1/42 (2.38%)  3/41 (7.32%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  3/41 (7.32%)  2/43 (4.65%)  4/39 (10.26%)  4/38 (10.53%)  1/41 (2.44%)  0/39 (0.00%)  3/40 (7.50%)  2/38 (5.26%)  3/38 (7.89%) 
Injury, poisoning and procedural complications                             
Muscle Strain * 1  0/42 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/43 (2.33%)  2/39 (5.13%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders                             
Arthralgia * 1  1/42 (2.38%)  1/41 (2.44%)  0/41 (0.00%)  1/42 (2.38%)  1/42 (2.38%)  1/41 (2.44%)  2/43 (4.65%)  3/39 (7.69%)  2/38 (5.26%)  0/41 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  1/38 (2.63%)  1/38 (2.63%) 
Back Pain * 1  0/42 (0.00%)  3/41 (7.32%)  1/41 (2.44%)  0/42 (0.00%)  2/42 (4.76%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/41 (2.44%)  1/39 (2.56%)  2/40 (5.00%)  1/38 (2.63%)  0/38 (0.00%) 
Nervous system disorders                             
Headache * 1  1/42 (2.38%)  3/41 (7.32%)  4/41 (9.76%)  1/42 (2.38%)  2/42 (4.76%)  0/41 (0.00%)  0/43 (0.00%)  1/39 (2.56%)  1/38 (2.63%)  0/41 (0.00%)  1/39 (2.56%)  2/40 (5.00%)  1/38 (2.63%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders                             
Cough * 1  1/42 (2.38%)  1/41 (2.44%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  2/41 (4.88%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  2/38 (5.26%)  1/38 (2.63%) 
Oropharyngeal Pain * 1  0/42 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  1/39 (2.56%)  2/40 (5.00%)  0/38 (0.00%)  0/38 (0.00%) 
Skin and subcutaneous tissue disorders                             
Psoriasis * 1  4/42 (9.52%)  1/41 (2.44%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/43 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/41 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  1/38 (2.63%) 
Vascular disorders                             
Hypertension * 1  1/42 (2.38%)  1/41 (2.44%)  0/41 (0.00%)  3/42 (7.14%)  1/42 (2.38%)  1/41 (2.44%)  0/43 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/41 (0.00%)  1/39 (2.56%)  2/40 (5.00%)  1/38 (2.63%)  1/38 (2.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director, Clinical Leader
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT01483599     History of Changes
Other Study ID Numbers: CR100673
CNTO1959PSO2001 ( Other Identifier: Janssen Inc. )
2011-001066-17 ( EudraCT Number )
First Submitted: November 29, 2011
First Posted: December 1, 2011
Results First Submitted: July 5, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017