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: February 11, 2015
Last verified: February 2015
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1: PLACEBO 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.
Group 2: USTEKINUMAB 45 MG 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.
Group 3: USTEKINUMAB 90 MG Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.

Participant Flow:   Overall Study
    Group 1: PLACEBO     Group 2: USTEKINUMAB 45 MG     Group 3: USTEKINUMAB 90 MG  
STARTED     206     205     204  
COMPLETED     162     158     170  
NOT COMPLETED     44     47     34  
Lack of Efficacy                 16                 15                 9  
Lost to Follow-up                 4                 5                 3  
Adverse Event                 12                 11                 8  
Withdrawal by Subject                 9                 11                 13  
Unspecified                 3                 5                 1  



  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.
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Reporting Groups
  Description
Group 1: PLACEBO 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.
Group 2: USTEKINUMAB 45 MG 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.
Group 3: USTEKINUMAB 90 MG Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
Total Total of all reporting groups

Baseline Measures
    Group 1: PLACEBO     Group 2: USTEKINUMAB 45 MG     Group 3: 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 ]

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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