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A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01009086
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : March 13, 2014
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Psoriatic
Interventions Drug: Placebo
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Enrollment 615
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: PLACEBO Group 2: USTEKINUMAB 45 MG Group 3: USTEKINUMAB 90 MG
Hide Arm/Group Description Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88. Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88. Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
Period Title: Overall Study
Started 206 205 204
Completed 162 158 170
Not Completed 44 47 34
Reason Not Completed
Lack of Efficacy             16             15             9
Lost to Follow-up             4             5             3
Adverse Event             12             11             8
Withdrawal by Subject             9             11             13
Other             3             5             1
Arm/Group Title Group 1: PLACEBO Group 2: USTEKINUMAB 45 MG Group 3: USTEKINUMAB 90 MG Total
Hide Arm/Group Description Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88. Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88. Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88. Total of all reporting groups
Overall Number of Baseline Participants 206 205 204 615
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 205 participants 204 participants 615 participants
47.4  (12.29) 47.1  (12.64) 46.8  (11.75) 47.1  (12.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 205 participants 204 participants 615 participants
Female
98
  47.6%
99
  48.3%
88
  43.1%
285
  46.3%
Male
108
  52.4%
106
  51.7%
116
  56.9%
330
  53.7%
1.Primary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
Hide Description An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg All Ustekinumab Combined
Hide Arm/Group Description:
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Overall Number of Participants Analyzed 206 205 204 409
Measure Type: Number
Unit of Measure: Percentage of participants
22.8 42.4 49.5 46.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, All Ustekinumab Combined
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 re-randomization test
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
Hide Description The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.
Time Frame Day 1 (Baseline) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg All Ustekinumab Combined
Hide Arm/Group Description:
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Overall Number of Participants Analyzed 206 205 204 409
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.10  (0.390) -0.31  (0.521) -0.40  (0.514) -0.36  (0.518)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, All Ustekinumab Combined
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 re-randomization test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
Hide Description The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg All Ustekinumab Combined
Hide Arm/Group Description:
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Overall Number of Participants Analyzed 146 145 149 294
Measure Type: Number
Unit of Measure: Percentage of participants
11.0 57.2 62.4 59.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, All Ustekinumab Combined
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 re-randomization test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Hide Description An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg All Ustekinumab Combined
Hide Arm/Group Description:
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Overall Number of Participants Analyzed 206 205 204 409
Measure Type: Number
Unit of Measure: Percentage of participants
8.7 24.9 27.9 26.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, All Ustekinumab Combined
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 re-randomization test
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
Hide Description An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg All Ustekinumab Combined
Hide Arm/Group Description:
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Overall Number of Participants Analyzed 206 205 204 409
Measure Type: Number
Unit of Measure: Percentage of participants
2.4 12.2 14.2 13.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, All Ustekinumab Combined
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 re-randomization test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
Hide Description The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.
Time Frame Day 1 (Baseline) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg All Ustekinumab Combined
Hide Arm/Group Description:
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Overall Number of Participants Analyzed 310 308 309 617
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.97  (3.852) 0.40  (2.110) 0.39  (2.403) 0.40  (2.260)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method re-randomization test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 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 re-randomization test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, All Ustekinumab Combined
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 re-randomization test
Comments [Not Specified]
Time Frame Baseline up to Week 108
Adverse Event Reporting Description Safety population included all participants who received the investigational drug and had safety data.
 
Arm/Group Title Placebo (CP) Ustekinumab 45 mg (CP) Ustekinumab 90 mg (CP) Placebo (After CP) Placebo -> Ustekinumab 45 mg (After CP) Ustekinumab 45 mg (After CP) Ustekinumab 90 mg (After CP)
Hide Arm/Group Description Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16. Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16. Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16. After Controlled period (Week 16-24) – participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24. After Controlled period (Week 16-108) – participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24. After Controlled period (Week 16-108) – participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status. After Controlled period (Week 16-108) – participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
All-Cause Mortality
Placebo (CP) Ustekinumab 45 mg (CP) Ustekinumab 90 mg (CP) Placebo (After CP) Placebo -> Ustekinumab 45 mg (After CP) Ustekinumab 45 mg (After CP) Ustekinumab 90 mg (After CP)
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) Ustekinumab 45 mg (CP) Ustekinumab 90 mg (CP) Placebo (After CP) Placebo -> Ustekinumab 45 mg (After CP) Ustekinumab 45 mg (After CP) Ustekinumab 90 mg (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/205 (1.95%)   5/205 (2.44%)   3/204 (1.47%)   2/140 (1.43%)   14/189 (7.41%)   20/203 (9.85%)   13/199 (6.53%) 
Blood and lymphatic system disorders               
Idiopathic Thrombocytopenic Purpura  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Cardiac disorders               
Acute Coronary Syndrome  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Acute Myocardial Infarction  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  1/199 (0.50%) 
Angina Pectoris  1  1/205 (0.49%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Atrial Fibrillation  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Atrioventricular Block  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Cardiac Failure Congestive  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Ischaemic Cardiomyopathy  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Myocardial Infarction  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  2/203 (0.99%)  0/199 (0.00%) 
Eye disorders               
Retinal Detachment  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Gastrointestinal disorders               
Colitis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Duodenitis  1  0/205 (0.00%)  1/205 (0.49%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Gastritis Haemorrhagic  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Gastroduodenitis  1  0/205 (0.00%)  0/205 (0.00%)  1/204 (0.49%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Gastrointestinal Haemorrhage  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Inguinal Hernia  1  0/205 (0.00%)  1/205 (0.49%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Pancreatitis Chronic  1  0/205 (0.00%)  0/205 (0.00%)  1/204 (0.49%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Rectal Haemorrhage  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
General disorders               
Chest Pain  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Hepatobiliary disorders               
Cholecystitis  1  0/205 (0.00%)  0/205 (0.00%)  1/204 (0.49%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Cholecystitis Acute  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Chronic Hepatitis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Infections and infestations               
Device Related Infection  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Erysipelas  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Escherichia Sepsis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Lobar Pneumonia  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Parotitis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Pharyngolaryngeal Abscess  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Pneumonia  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Pneumonia Mycoplasmal  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Postoperative Wound Infection  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Proteus Infection  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Salpingitis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Injury, poisoning and procedural complications               
Joint Dislocation  1  1/205 (0.49%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Radius Fracture  1  1/205 (0.49%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Spinal Compression Fracture  1  0/205 (0.00%)  1/205 (0.49%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Metabolism and nutrition disorders               
Dehydration  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  1/199 (0.50%) 
Musculoskeletal and connective tissue disorders               
Arthritis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Finger Deformity  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Foot Deformity  1  1/205 (0.49%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Lumbar Spinal Stenosis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Osteoarthritis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  1/199 (0.50%) 
Osteoporotic Fracture  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Psoriatic Arthropathy  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Spinal Column Stenosis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Synovial Cyst  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
B-Cell Lymphoma  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Renal Cell Carcinoma  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Squamous Cell Carcinoma  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Uterine Leiomyoma  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Nervous system disorders               
Intracranial Aneurysm  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Ischaemic Stroke  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Presyncope  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Psychiatric disorders               
Anxiety  1  0/205 (0.00%)  0/205 (0.00%)  1/204 (0.49%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Depression  1  0/205 (0.00%)  0/205 (0.00%)  1/204 (0.49%)  1/140 (0.71%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Suicidal Ideation  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  1/140 (0.71%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Renal and urinary disorders               
Renal Failure Acute  1  0/205 (0.00%)  1/205 (0.49%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Tubulointerstitial Nephritis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Reproductive system and breast disorders               
Cervical Polyp  1  0/205 (0.00%)  1/205 (0.49%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Asthma  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  1/203 (0.49%)  0/199 (0.00%) 
Skin and subcutaneous tissue disorders               
Erythrodermic Psoriasis  1  0/205 (0.00%)  0/205 (0.00%)  1/204 (0.49%)  1/140 (0.71%)  0/189 (0.00%)  0/203 (0.00%)  0/199 (0.00%) 
Urticaria  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  0/203 (0.00%)  0/199 (0.00%) 
Vascular disorders               
Aortic Aneurysm  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Deep Vein Thrombosis  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  0/189 (0.00%)  0/203 (0.00%)  1/199 (0.50%) 
Hypertension  1  0/205 (0.00%)  0/205 (0.00%)  0/204 (0.00%)  0/140 (0.00%)  1/189 (0.53%)  1/203 (0.49%)  0/199 (0.00%) 
Indicates events were collected by 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) Ustekinumab 45 mg (CP) Ustekinumab 90 mg (CP) Placebo (After CP) Placebo -> Ustekinumab 45 mg (After CP) Ustekinumab 45 mg (After CP) Ustekinumab 90 mg (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/205 (14.63%)   17/205 (8.29%)   29/204 (14.22%)   7/140 (5.00%)   50/189 (26.46%)   42/203 (20.69%)   57/199 (28.64%) 
Infections and infestations               
Nasopharyngitis  1  8/205 (3.90%)  8/205 (3.90%)  11/204 (5.39%)  2/140 (1.43%)  15/189 (7.94%)  18/203 (8.87%)  20/199 (10.05%) 
Upper Respiratory Tract Infection  1  10/205 (4.88%)  5/205 (2.44%)  9/204 (4.41%)  2/140 (1.43%)  16/189 (8.47%)  14/203 (6.90%)  12/199 (6.03%) 
Urinary Tract Infection  1  2/205 (0.98%)  1/205 (0.49%)  2/204 (0.98%)  1/140 (0.71%)  6/189 (3.17%)  4/203 (1.97%)  11/199 (5.53%) 
Musculoskeletal and connective tissue disorders               
Psoriatic Arthropathy  1  7/205 (3.41%)  0/205 (0.00%)  4/204 (1.96%)  0/140 (0.00%)  10/189 (5.29%)  6/203 (2.96%)  9/199 (4.52%) 
Vascular disorders               
Hypertension  1  4/205 (1.95%)  3/205 (1.46%)  6/204 (2.94%)  2/140 (1.43%)  7/189 (3.70%)  9/203 (4.43%)  11/199 (5.53%) 
Indicates events were collected by 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: Director, Clinical Research
Organization: Janssen Research & Development, LLC
Phone: 1-800-526-7736
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01009086     History of Changes
Obsolete Identifiers: NCT01902706
Other Study ID Numbers: CR016315
CNTO1275PSA3001 ( Other Identifier: Janssen Research & Development, LLC )
2009-012264-14 ( EudraCT Number )
First Submitted: November 5, 2009
First Posted: November 6, 2009
Results First Submitted: October 11, 2013
Results First Posted: March 13, 2014
Last Update Posted: March 3, 2015