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Trial record 33 of 37 for:    Developmental Disabilities | ( Map: Oregon, United States )

A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents

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ClinicalTrials.gov Identifier: NCT01077362
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : February 27, 2014
Last Update Posted : February 27, 2014
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 312
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Period Title: Overall Study
Started 104 103 105
Completed 73 84 81
Not Completed 31 19 24
Reason Not Completed
Lack of Efficacy             13             8             10
Lost to Follow-up             1             0             3
Adverse Event             12             7             4
Withdrawal by Subject             5             3             5
Not Specified             0             1             2
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg Total
Hide Arm/Group Description Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 104 103 105 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 103 participants 105 participants 312 participants
47.6  (11.19) 48  (11.21) 48.2  (12.36) 47.9  (11.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 103 participants 105 participants 312 participants
Female
53
  51.0%
55
  53.4%
56
  53.3%
164
  52.6%
Male
51
  49.0%
48
  46.6%
49
  46.7%
148
  47.4%
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 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Overall Number of Participants Analyzed 104 103 105 208
Measure Type: Number
Unit of Measure: Percentage of participants
20.2 43.7 43.8 43.8
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 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Overall Number of Participants Analyzed 104 103 105 208
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.03  (0.380) -0.21  (0.461) -0.22  (0.436) -0.21  (0.447)
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 0.002
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 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. 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Overall Number of Participants Analyzed 80 80 81 161
Measure Type: Number
Unit of Measure: Percentage of participants
5.0 51.3 55.6 53.4
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]
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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Overall Number of Participants Analyzed 104 103 105 208
Measure Type: Number
Unit of Measure: Percentage of participants
6.7 17.5 22.9 20.2
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 0.018
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 0.002
Comments [Not Specified]
Method re-randomization test
Comments [Not Specified]
5.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 scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the 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 the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
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]
6.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 escaped, 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Overall Number of Participants Analyzed 104 103 105 208
Measure Type: Number
Unit of Measure: Percentage of participants
2.9 6.8 8.6 7.7
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 0.171
Comments [Not Specified]
Method re-randomization
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 0.060
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 0.094
Comments [Not Specified]
Method re-randomization
Comments [Not Specified]
Time Frame Adverse event data were collected for the duration of the study (60 weeks).
Adverse Event Reporting Description The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
 
Arm/Group Title Placebo: Controlled Period Ustekinumab 45 mg: Controlled Period Ustekinumab 90 mg: Controlled Period Placebo: Weeks 16-24 Placebo -> Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 90 mg: Weeks 16-60
Hide Arm/Group Description Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline. Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline. Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline. Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16. Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24. Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline. Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
All-Cause Mortality
Placebo: Controlled Period Ustekinumab 45 mg: Controlled Period Ustekinumab 90 mg: Controlled Period Placebo: Weeks 16-24 Placebo -> Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 90 mg: Weeks 16-60
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: Controlled Period Ustekinumab 45 mg: Controlled Period Ustekinumab 90 mg: Controlled Period Placebo: Weeks 16-24 Placebo -> Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 90 mg: Weeks 16-60
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/104 (4.81%)   0/103 (0.00%)   1/104 (0.96%)   0/60 (0.00%)   2/80 (2.50%)   6/100 (6.00%)   6/99 (6.06%) 
Blood and lymphatic system disorders               
Thrombocytopenia  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
Cardiac disorders               
Acute Myocardial Infarction  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Angina Unstable  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
Myocardial Infarction  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  2/100 (2.00%)  0/99 (0.00%) 
Gastrointestinal disorders               
Gastric Ulcer Haemorrhage  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Gastrointestinal Haemorrhage  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
Inguinal Hernia  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Intestinal Haemorrhage  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
Umbilical Hernia  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  1/80 (1.25%)  0/100 (0.00%)  0/99 (0.00%) 
Upper Gastrointestinal Haemorrhage  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
General disorders               
Pyrexia  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Hepatobiliary disorders               
Cholecystitis Chronic  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Infections and infestations               
Bacteraemia  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Gastrointestinal Candidiasis  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Septic Shock  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Injury, poisoning and procedural complications               
Cervical Vertebral Fracture  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Metabolism and nutrition disorders               
Hyperglycaemia  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthritis  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Bursitis  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Joint Effusion  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
Tendonitis  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Breast Cancer  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  1/80 (1.25%)  0/100 (0.00%)  0/99 (0.00%) 
Nervous system disorders               
Cerebrovascular Insufficiency  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Syncope  1  0/104 (0.00%)  0/103 (0.00%)  1/104 (0.96%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Psychiatric disorders               
Depression  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Suicide Attempt  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Renal and urinary disorders               
Renal Failure Acute  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Renal Injury  1  0/104 (0.00%)  0/103 (0.00%)  1/104 (0.96%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Interstitial Lung Disease  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Skin and subcutaneous tissue disorders               
Psoriasis  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Scar  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  1/100 (1.00%)  0/99 (0.00%) 
Vascular disorders               
Arteriosclerosis  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Hypertension  1  1/104 (0.96%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  0/99 (0.00%) 
Hypotension  1  0/104 (0.00%)  0/103 (0.00%)  0/104 (0.00%)  0/60 (0.00%)  0/80 (0.00%)  0/100 (0.00%)  1/99 (1.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo: Controlled Period Ustekinumab 45 mg: Controlled Period Ustekinumab 90 mg: Controlled Period Placebo: Weeks 16-24 Placebo -> Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 45 mg: Weeks 16-60 Ustekinumab 90 mg: Weeks 16-60
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/104 (18.27%)   16/103 (15.53%)   19/104 (18.27%)   5/60 (8.33%)   10/80 (12.50%)   16/100 (16.00%)   24/99 (24.24%) 
Infections and infestations               
Bronchitis  1  3/104 (2.88%)  1/103 (0.97%)  0/104 (0.00%)  0/60 (0.00%)  2/80 (2.50%)  2/100 (2.00%)  8/99 (8.08%) 
Nasopharyngitis  1  5/104 (4.81%)  8/103 (7.77%)  10/104 (9.62%)  3/60 (5.00%)  3/80 (3.75%)  6/100 (6.00%)  8/99 (8.08%) 
Sinusitis  1  3/104 (2.88%)  1/103 (0.97%)  3/104 (2.88%)  0/60 (0.00%)  1/80 (1.25%)  0/100 (0.00%)  5/99 (5.05%) 
Musculoskeletal and connective tissue disorders               
Psoriatic Arthropathy  1  5/104 (4.81%)  4/103 (3.88%)  1/104 (0.96%)  1/60 (1.67%)  1/80 (1.25%)  6/100 (6.00%)  2/99 (2.02%) 
Nervous system disorders               
Headache  1  4/104 (3.85%)  5/103 (4.85%)  5/104 (4.81%)  1/60 (1.67%)  4/80 (5.00%)  2/100 (2.00%)  3/99 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director, Clinical Research
Organization: Janssen Research & Development, LLC
Phone: 1-800-526-7736
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01077362     History of Changes
Other Study ID Numbers: CR016483
CNTO1275PSA3002 ( Other Identifier: Janssen Research & Development, LLC )
2009-012265-60 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: October 11, 2013
Results First Posted: February 27, 2014
Last Update Posted: February 27, 2014