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
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 104 participants | 103 participants | 105 participants | 312 participants | |
Female |
53 51.0%
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55 53.4%
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56 53.3%
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164 52.6%
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Male |
51 49.0%
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48 46.6%
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49 46.7%
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148 47.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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):
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 |