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Trial record 11 of 811 for:    Psoriasis 4

Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)

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ClinicalTrials.gov Identifier: NCT01999868
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : December 25, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Biological: Ustekinumab
Biological: Abatacept
Drug: UST Placebo
Drug: ABA Placebo
Enrollment 108
Recruitment Details 148 participants were screened and 108 of those participants were enrolled at 8 sites in the US and 2 sites in Canada between March 2014 and April 2016
Pre-assignment Details Enrolled participants received open-label ustekinumab in the lead-in phase (Week 0 to 12). Participants with at least 75% reduction in Psoriasis Area Severity Index (PASI) score at Week 12 compared to Week 0 were eligible for the blinded treatment phase (Week 12 to 40).
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo Ustekinumab, Not Randomized
Hide Arm/Group Description Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28. Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39. Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group.
Period Title: Lead-in Phase (Week 0 – 12)
Started 45 46 17
Completed 45 46 12
Not Completed 0 0 5
Reason Not Completed
Lost to Follow-up             0             0             5
Period Title: Blinded Treatment Phase (Week 12 – 40)
Started 45 46 0 [1]
Completed 27 35 0
Not Completed 18 11 0
Reason Not Completed
Adverse Event             1             1             0
Lost to Follow-up             3             4             0
Pregnancy             0             1             0
Withdrawal by Subject             0             2             0
Met study drug Discontinuation Criteria             1             2             0
Met psoriasis relapse criterion             8             1             0
Transportation issues             1             0             0
Worsening psoriasis             4             0             0
[1]
Participants didn't meet eligibility requirements for randomization or withdrew prior to Week 12.
Period Title: Blinded Observation Phase (Week 40 – 88)
Started 27 35 0
Completed 4 6 0
Not Completed 23 29 0
Reason Not Completed
Adverse Event             0             1             0
Lost to Follow-up             0             1             0
Withdrawal by Subject             1             2             0
Met psoriasis relapse criterion             10             19             0
Terminated early from study in error             0             2             0
Worsening psoriasis             12             4             0
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo Ustekinumab, Not Randomized Total
Hide Arm/Group Description Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28. Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39. Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group. Total of all reporting groups
Overall Number of Baseline Participants 45 46 17 108
Hide Baseline Analysis Population Description
Subjects that signed informed consent, were eligible for the study, and were administered at least one dose of open-label ustekinumab in the lead-in phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 46 participants 17 participants 108 participants
49.4  (10.5) 44.1  (11.8) 42.8  (15.0) 46.1  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 17 participants 108 participants
Female
18
  40.0%
14
  30.4%
3
  17.6%
35
  32.4%
Male
27
  60.0%
32
  69.6%
14
  82.4%
73
  67.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 17 participants 108 participants
Hispanic or Latino
3
   6.7%
7
  15.2%
2
  11.8%
12
  11.1%
Not Hispanic or Latino
42
  93.3%
39
  84.8%
15
  88.2%
96
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 17 participants 108 participants
American Indian or Alaska Native
1
   2.2%
0
   0.0%
0
   0.0%
1
   0.9%
Asian
3
   6.7%
1
   2.2%
0
   0.0%
4
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.7%
3
   6.5%
0
   0.0%
6
   5.6%
White
36
  80.0%
42
  91.3%
17
 100.0%
95
  88.0%
More than one race
2
   4.4%
0
   0.0%
0
   0.0%
2
   1.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 17 participants 108 participants
Canada 15 14 6 35
United States 30 32 11 73
Psoriasis Area Severity Index (PASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 45 participants 46 participants 17 participants 108 participants
19.2  (8.1) 20.0  (8.2) 21.2  (7.7) 19.9  (8.1)
[1]
Measure Description: Baseline Psoriasis Area Severity Index (PASI) score was the score assessed at Week 0. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Psoriasis Area Severity Index (PASI) (Randomization Strata)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 17 participants 108 participants
Low (12 – 20)
31
  68.9%
32
  69.6%
8
  47.1%
71
  65.7%
High (>20)
14
  31.1%
14
  30.4%
9
  52.9%
37
  34.3%
[1]
Measure Description: Number of participants with low and high Psoriasis Area Severity Index (PASI) scores. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). Scores of 12-20 were considered “low” and scores >20, “high.”
Physician's Global Assessment (PGA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 45 participants 46 participants 17 participants 108 participants
3.5  (0.7) 3.3  (0.5) 3.5  (0.6) 3.4  (0.6)
[1]
Measure Description: The Physician's Global Assessment (PGA) is an overall assessment of psoriasis severity. Duration, erythema and scaling are assessed, averaged, and given a score ranging from 0 to 5 based on the majority of the psoriatic lesions, with higher scores indicating worse disease. A PGA average score < 1.5 was classified as “cleared or minimal.”
Physician's Global Assessment (PGA) Score (Categorical)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 17 participants 108 participants
Cleared or Minimal (PGA <1.5)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Worse than Minimal (PGA ≥ 1.5)
45
 100.0%
46
 100.0%
17
 100.0%
108
 100.0%
[1]
Measure Description: Number of participants with “cleared or minimal” average Physician's Global Assessment (PGA) scores and those with average PGA scores worse than minimal. The Physician's Global Assessment (PGA) is an overall assessment of psoriasis severity. Duration, erythema and scaling are assessed, averaged, and given a score ranging from 0 to 5 based on the majority of the psoriatic lesions, with higher scores indicating worse disease. A PGA average score < 1.5 was classified as “cleared or minimal.”
Dermatology Life Quality Index (DLQI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 45 participants 46 participants 17 participants 108 participants
14.2  (8.1) 13.5  (7.0) 13.5  (8.8) 13.8  (7.7)
[1]
Measure Description: Dermatology Life Quality Index (DLQI) is a 10-question, participant-reported questionnaire assessing quality of life with respect to skin conditions in the areas of Symptoms and Feelings; Daily Activities; Leisure; Work and School; Personal Relationships; and Treatment. Each question measures the effect the skin condition has on a participant’s quality of life. Responses range from “Not at all” (score = 0) to “Very much” (score = 3). The overall score is the sum for all 10 questions and ranges from 0-30, with higher scores indicating a poor quality of life.
1.Primary Outcome
Title Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)
Hide Description The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI –Week 12 PASI)/2]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Time Frame Post-randomization (Week 12 to 88)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 12-88 Number Analyzed 45 participants 46 participants
91.1 87.0
Week 12-40 Number Analyzed 45 participants 46 participants
55.6 30.4
Week 28-88 Number Analyzed 36 participants 38 participants
88.9 84.2
Week 40-88 Number Analyzed 26 participants 36 participants
84.6 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
2.Secondary Outcome
Title Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)
Hide Description The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI –Week 12 PASI). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were considered to have not experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Time Frame Post-randomization (Week 12 to 88)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 12-88 Number Analyzed 45 participants 46 participants
75.6 52.2
Week 12-40 Number Analyzed 45 participants 46 participants
42.2 10.9
Week 28-88 Number Analyzed 36 participants 38 participants
83.3 60.5
Week 40-88 Number Analyzed 26 participants 36 participants
80.8 63.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
3.Secondary Outcome
Title Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)
Hide Description The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI –Week 12 PASI). Participants who terminated early due to reasons other than psoriasis relapse or worsening psoriasis were considered to have a missing relapse status at time of drop-out and were excluded from the analyses. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Time Frame Post-randomization (Week 12 to 88)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 12-88 Number Analyzed 38 participants 30 participants
89.5 80.0
Week 12-40 Number Analyzed 39 participants 37 participants
48.7 13.5
Week 28-88 Number Analyzed 34 participants 29 participants
88.2 79.3
Week 40-88 Number Analyzed 25 participants 29 participants
84.0 79.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
4.Secondary Outcome
Title Time to Psoriasis Relapse (Treating Drop-Outs as Relapse)
Hide Description Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI –Week 12 PASI)/2]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Time Frame Post-randomization (Week 12 to 88)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Median (95% Confidence Interval)
Unit of Measure: weeks
28
(24 to 40)
40
(32 to 44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments Two-sided test.
Method Grouped survival analysis
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Two-sided test.
Method Grouped survival analysis
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
5.Secondary Outcome
Title Time to Psoriasis Relapse (Treating Drop-Outs as Censored)
Hide Description Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI –Week 12 PASI)/2]). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were censored at the time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Time Frame Post-randomization (Week 12 to 88)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Median (95% Confidence Interval)
Unit of Measure: weeks
28
(28 to 40)
48
(44 to 56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Two-sided test.
Method Grouped survival analysis
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Two-sided test.
Method Grouped survival analysis
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
6.Secondary Outcome
Title Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA)
Hide Description Percentage of participants who were classified as cleared or minimal in the Physician's Global Assessment (PGA) average score at the specified post-randomization time point. The PGA assesses the severity of the psoriasis in 3 components: induration, erythema and scaling. Each component is given a score ranging from 0 to 5 based on the majority of the participant’s psoriasis lesions, with higher scores indicating worse disease. A PGA average score < 1.5 was classified as “cleared or minimal.”
Time Frame Week 40, Week 88
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 40 Number Analyzed 26 participants 34 participants
26.9 58.8
Week 88 Number Analyzed 4 participants 6 participants
75.0 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments Two-sided test.
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 88
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Regression, Logistic
Comments Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.
7.Secondary Outcome
Title Change in Dermatology Life Quality Index (DLQI)
Hide Description Change in the Dermatology Life Quality Index (DLQI) score from Week 12 to the specified post-randomization time point. DLQI is a 10-question, participant-reported questionnaire that assesses quality of life with respect to skin conditions in the areas of symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question measures the level of effect that the skin condition has on quality of life, and responses range from ‘Not at all’ (score = 0) to ‘Very much’ (score = 3). The overall score is the sum of the scores for all 10 questions and ranges from 0-30, with higher scores indicating worse quality of life.
Time Frame Week 40, Week 88
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 40 Number Analyzed 26 participants 34 participants
2.2  (5.3) 0.6  (3.9)
Week 88 Number Analyzed 4 participants 6 participants
-4.3  (3.7) 0.0  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments Two-sided test.
Method ANCOVA
Comments Randomization stratum (PASI score at week 0: 12-20 or >20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Abatacept + Ustekinumab Placebo, Ustekinumab, Ustekinumab + Abatacept Placebo
Comments Week 12 to 88
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments Two-sided test.
Method ANCOVA
Comments Randomization (PASI score week 0:12-20 or >20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates
8.Secondary Outcome
Title Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Hide Description Number of participants who experienced adverse events (AEs) during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute’s (NCI’s) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.
Time Frame Lead-In Phase (Week 0 to 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received at least one dose of treatment after enrollment.
Arm/Group Title Safety
Hide Arm/Group Description:
The safety population includes all participants who received at least one dose of treatment after enrollment.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: Number of participants
All AEs 30
AEs indicated as serious 2
AEs with an outcome of death 0
AEs of special interest 0
Grade 2 AEs 28
Grade 3 AEs 2
Grade 4 AEs 0
Grade 1 Psoriatic Arthritis AEs 2
Grade 2 Psoriatic Arthritis AEs 0
Grade 3 Psoriatic Arthritis AEs 0
AEs that lead to study drug discontinuation 0
AEs related to open label Ustekinumab 11
9.Secondary Outcome
Title Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Hide Description Number of adverse events (AEs) that occurred during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute’s (NCI’s) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.
Time Frame Lead-In Phase (Week 0 to 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received at least one dose of treatment after enrollment.
Arm/Group Title Safety
Hide Arm/Group Description:
The safety population includes all participants who received at least one dose of treatment after enrollment.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: Number of Events
All AEs 51
AEs indicated as serious 2
AEs with an outcome of death 0
AEs of special interest 0
Grade 2 AEs 47
Grade 3 AEs 2
Grade 4 AEs 0
Grade 1 Psoriatic Arthritis AEs 2
Grade 2 Psoriatic Arthritis AEs 0
Grade 3 Psoriatic Arthritis AEs 0
AEs that lead to study drug discontinuation 0
AEs related to open label Ustekinumab 20
10.Secondary Outcome
Title Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Hide Description Number of participants who experienced adverse events (AEs) during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute’s (NCI’s) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.
Time Frame From randomization (Week 12) to last safety follow-up visit (up to Week 100)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Measure Type: Number
Unit of Measure: Number of participants
All AEs 28 22
AEs indicated as serious 2 5
AEs with an outcome of death 0 0
AEs of special interest 2 1
Grade 2 AEs (CTCAE) 27 20
Grade 3 AEs (CTCAE) 4 7
Grade 4 AEs (CTCAE) 0 2
Grade 1 Psoriatic Arthritis AEs 0 0
Grade 2 Psoriatic Arthritis AEs 2 1
Grade 3 Psoriatic Arthritis AEs 0 0
AEs that lead to study drug discontinuation 1 2
AEs related to open-label Ustekinumab 5 8
AEs related to Ustekinumab/Ustekinumab Placebo 7 9
AEs related to Abatacept/Abatacept Placebo 11 11
11.Secondary Outcome
Title Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Hide Description Number of adverse events (AEs) that occurred during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute’s (NCI’s) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.
Time Frame From randomization (Week 12) to last safety follow-up visit (up to Week 100)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Arm/Group Title Ustekinumab, Abatacept + Ustekinumab Placebo Ustekinumab, Ustekinumab + Abatacept Placebo
Hide Arm/Group Description:
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
Overall Number of Participants Analyzed 45 46
Measure Type: Number
Unit of Measure: Number of Events
All AEs 59 59
AEs indicated as serious 2 9
AEs with an outcome of death 0 0
AEs of special interest 2 1
Grade 2 AEs (CTCAE) 53 47
Grade 3 AEs (CTCAE) 4 7
Grade 4 AEs (CTCAE) 0 4
Grade 1 Psoriatic Arthritis AEs 0 0
Grade 2 Psoriatic Arthritis AEs 2 1
Grade 3 Psoriatic Arthritis AEs 0 0
AEs that lead to study drug discontinuation 1 3
AEs related to open-label Ustekinumab 5 11
AEs related to Ustekinumab/Ustekinumab Placebo 9 17
AEs related to Abatacept/Abatacept Placebo 15 20
Time Frame Week 0 to Week 100
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title UST Open Label Post Randomization: UST, ABA/UST Placebo Post Randomization: UST, UST/ABA Placebo
Hide Arm/Group Description Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase. Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28. Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.
All-Cause Mortality
UST Open Label Post Randomization: UST, ABA/UST Placebo Post Randomization: UST, UST/ABA Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)      0/45 (0.00%)      0/46 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
UST Open Label Post Randomization: UST, ABA/UST Placebo Post Randomization: UST, UST/ABA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/108 (1.85%)      2/45 (4.44%)      5/46 (10.87%)    
Ear and labyrinth disorders       
Vertigo  1  1/108 (0.93%)  1 0/45 (0.00%)  0 0/46 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis acute  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
Infections and infestations       
Gastroenteritis  1  0/108 (0.00%)  0 1/45 (2.22%)  1 0/46 (0.00%)  0
Postoperative wound infection  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
Injury, poisoning and procedural complications       
Post procedural complication  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
Metabolism and nutrition disorders       
Diabetic ketoacidosis  1  0/108 (0.00%)  0 1/45 (2.22%)  1 0/46 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
Cervical spinal stenosis  1  1/108 (0.93%)  1 0/45 (0.00%)  0 0/46 (0.00%)  0
Lumbar spinal stenosis  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Renal cell carcinoma  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  2
Pulmonary embolism  1  0/108 (0.00%)  0 0/45 (0.00%)  0 1/46 (2.17%)  1
1
Term from vocabulary, 17.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UST Open Label Post Randomization: UST, ABA/UST Placebo Post Randomization: UST, UST/ABA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/108 (3.70%)      6/45 (13.33%)      6/46 (13.04%)    
Infections and infestations       
Upper respiratory tract infection  1  4/108 (3.70%)  4 1/45 (2.22%)  1 5/46 (10.87%)  9
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/108 (0.00%)  0 5/45 (11.11%)  5 2/46 (4.35%)  2
1
Term from vocabulary, 17.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01999868     History of Changes
Other Study ID Numbers: DAIT ITN059AI
First Submitted: November 26, 2013
First Posted: December 3, 2013
Results First Submitted: December 4, 2018
Results First Posted: December 25, 2018
Last Update Posted: January 15, 2019