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: January 28, 2014
Last verified: January 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 ]

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
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Time Frame Adverse event data were collected for the duration of the study (108 weeks). Data currently reported are for the first 52 weeks of the study; 108 week data will be reported after they become available.
Additional 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 placebo group, did not receive treatment and was excluded from the safety analysis set.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo: Controlled Period Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
Ustekinumab 45 mg: Controlled Period Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
Ustekinumab 90 mg: Controlled Period Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
Placebo: Weeks 16-24 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.
Placebo -> Ustekinumab 45 mg: Weeks 16-52 Adverse events which occurred (1) during Weeks 16-52 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-52 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
Ustekinumab 45 mg: Weeks 16-52 Adverse events which occurred during Weeks 16-52 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
Ustekinumab 90 mg: Weeks 16-52 Adverse events which occurred during Weeks 16-52 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.

Other Adverse Events
    Placebo: Controlled Period     Ustekinumab 45 mg: Controlled Period     Ustekinumab 90 mg: Controlled Period     Placebo: Weeks 16-24     Placebo -> Ustekinumab 45 mg: Weeks 16-52     Ustekinumab 45 mg: Weeks 16-52     Ustekinumab 90 mg: Weeks 16-52  
Total, other (not including serious) adverse events                
# participants affected / at risk     8/205     8/205     11/204     2/140     8/189     10/203     12/199  
Infections and infestations                
Nasopharyngitis † 1              
# participants affected / at risk     8/205 (3.90%)     8/205 (3.90%)     11/204 (5.39%)     2/140 (1.43%)     8/189 (4.23%)     10/203 (4.93%)     12/199 (6.03%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 15.1



  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: January 28, 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