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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01009086
First received: November 5, 2009
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: October 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Psoriatic
Interventions: Drug: Placebo
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study duration was through Week 108. Week 0 to Week 52 data are presented here. This record will be updated with final data when they become available.

Reporting Groups
  Description
Placebo: Baseline to Week 52 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 88. 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 88. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Ustekinumab 45 mg: Baseline to Week 52 Participants received SC 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, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Ustekinumab 90 mg: Baseline to Week 52 Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.

Participant Flow:   Overall Study
    Placebo: Baseline to Week 52     Ustekinumab 45 mg: Baseline to Week 52     Ustekinumab 90 mg: Baseline to Week 52  
STARTED     206     205     204  
COMPLETED     175     180     182  
NOT COMPLETED     31     25     22  
Lack of Efficacy                 10                 10                 4  
Lost to Follow-up                 2                 0                 2  
Adverse Event                 13                 5                 8  
Withdrawal by Subject                 5                 7                 8  
Not Specified                 1                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 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 88. 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 88. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Ustekinumab 45 mg Participants received SC 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, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Ustekinumab 90 mg Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Total Total of all reporting groups

Baseline Measures
    Placebo     Ustekinumab 45 mg     Ustekinumab 90 mg     Total  
Number of Participants  
[units: participants]
  206     205     204     615  
Age  
[units: years]
Mean ± Standard Deviation
  47.4  ± 12.29     47.1  ± 12.64     46.8  ± 11.75     47.1  ± 12.21  
Gender  
[units: participants]
       
Female     98     99     88     285  
Male     108     106     116     330  



  Outcome Measures
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1.  Primary:   Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.   [ Time Frame: Week 24 ]

2.  Secondary:   Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)   [ Time Frame: Day 1 (Baseline) and Week 24 ]

3.  Secondary:   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   [ Time Frame: Week 24 ]

4.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24   [ Time Frame: Week 24 ]
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Measure Type Secondary
Measure Title Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo 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 88. 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 88. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
Ustekinumab 45 mg Participants received SC 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, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Ustekinumab 90 mg Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
All Ustekinumab Combined Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.

Measured Values
    Placebo     Ustekinumab 45 mg     Ustekinumab 90 mg     All Ustekinumab Combined  
Number of Participants Analyzed  
[units: participants]
  206     205     204     409  
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24  
[units: Percentage¬†of¬†participants]
  8.7     24.9     27.9     26.4  


Statistical Analysis 1 for Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Groups [1] Placebo vs. Ustekinumab 45 mg
Method [2] re-randomization test
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Groups [1] Placebo vs. Ustekinumab 90 mg
Method [2] re-randomization test
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Groups [1] Placebo vs. All Ustekinumab Combined
Method [2] re-randomization test
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   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   [ Time Frame: Day 1 (Baseline) and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen Research & Development, LLC
phone: 1-800-526-7736


No publications provided by Janssen Research & Development, LLC

Publications automatically indexed to this study:

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01009086     History of Changes
Obsolete Identifiers: NCT01902706
Other Study ID Numbers: CR016315, CNTO1275PSA3001, 2009-012264-14
Study First Received: November 5, 2009
Results First Received: October 11, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines