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

• 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: Janssen Research & Development, LLC
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Ustekinumab 45 mg	Ustekinumab 90 mg
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
Other	0	1	2

Baseline Characteristics

Arm/Group Title		Placebo	Ustekinumab 45 mg	Ustekinumab 90 mg	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
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

Outcome Measure Data

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
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

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]

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]

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)
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

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
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

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]

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]

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
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

Outcome Measure Data

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
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

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]

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]

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
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

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
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

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]

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]

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]

Adverse Events

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
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	--/--	--/--	--/--	--/--	--/--	--/--	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Helliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1). pii: e001149. doi: 10.1136/rmdopen-2019-001149.

Siebert S, Sweet K, Dasgupta B, Campbell K, McInnes IB, Loza MJ. Responsiveness of Serum C-Reactive Protein, Interleukin-17A, and Interleukin-17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2019 Oct;71(10):1660-1669. doi: 10.1002/art.40921. Epub 2019 Sep 3.

Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.

Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01077362
• 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