A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00320216
First received: April 28, 2006
Last updated: January 14, 2013
Last verified: January 2013
Results First Received: October 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Ustekinumab
Drug: Placebo

  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
320 participants from 45 sites in North America were randomized to receive either Ustekinumab or placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo (CP) Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
Ustekinumab 45 mg (CP) Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
Ustekinumab 90 mg (CP) Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
Ustekinumab 45 mg Weekly for 4 Weeks (CP) Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
Ustekinumab 90 mg Weekly for 4 Weeks (CP) Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.

Participant Flow:   Overall Study
    Placebo (CP)     Ustekinumab 45 mg (CP)     Ustekinumab 90 mg (CP)     Ustekinumab 45 mg Weekly for 4 Weeks (CP)     Ustekinumab 90 mg Weekly for 4 Weeks (CP)  
STARTED     64     64 [1]   64 [1]   64     64  
COMPLETED     48     54     58     61     58  
NOT COMPLETED     16     10     6     3     6  
Adverse Event                 0                 6                 0                 2                 2  
Lack of Efficacy                 6                 2                 1                 0                 1  
Lost to Follow-up                 3                 0                 0                 0                 0  
Other                 7                 2                 5                 1                 3  
[1] 1 patient randomized but not treated was included as discontinued due to Other reason.



  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
Group I: Placebo Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
Group II: Ustekinumab 45 mg Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
Group III: Ustekinumab 90 mg Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
Group IV: Ustekinumab 45 mg Weekly for 4 Weeks Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
Group V: Ustekinumab 90 mg Weekly for 4 Weeks Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
Total Total of all reporting groups

Baseline Measures
    Group I: Placebo     Group II: Ustekinumab 45 mg     Group III: Ustekinumab 90 mg     Group IV: Ustekinumab 45 mg Weekly for 4 Weeks     Group V: Ustekinumab 90 mg Weekly for 4 Weeks     Total  
Number of Participants  
[units: participants]
  64     64     64     64     64     320  
Age  
[units: Years]
Mean ± Standard Deviation
           
Years     44.0  ± 13.7     46.4  ± 14.2     45.5  ± 12.7     44.5  ± 12.2     44.3  ± 13.3     44.9  ± 13.2  
Gender  
[units: participants]
           
Female     18     26     17     25     52     138  
Male     46     38     47     39     12     182  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32   [ Time Frame: Week 32 ]

4.  Secondary:   Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28   [ Time Frame: Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.  


Results Point of Contact:  
Name/Title: Senior Director Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399


No publications provided by Centocor, Inc.

Publications automatically indexed to this study:

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00320216     History of Changes
Obsolete Identifiers: NCT00322998
Other Study ID Numbers: CR005416, C0379T04
Study First Received: April 28, 2006
Results First Received: October 23, 2009
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration