A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis (PHOENIX1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor Research & Development, Inc.
ClinicalTrials.gov Identifier:
NCT00267969
First received: December 20, 2005
Last updated: June 10, 2013
Last verified: June 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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In this study, 766 patients were randomized in North America and Europe to receive either placebo or ustekinumab (CNTO 1275).

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 0-12) - Placebo group
Ustekinumab 45 mg (CP) Controlled period (Week 0-12) - Ustekinumab 45 mg group
Ustekinumab 90 mg (CP) Controlled period (Week 0-12) - Ustekinumab 90 mg group
Placebo -> Ustekinumab 45 mg (After CP) After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
Placebo -> Ustekinumab 90 mg (After CP) After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
Ustekinumab 45 mg (After CP) After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
Ustekinumab 90 mg (After CP) After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.

Participant Flow for 2 periods

Period 1:   Controlled Period
    Placebo (CP)     Ustekinumab 45 mg (CP)     Ustekinumab 90 mg (CP)     Placebo -> Ustekinumab 45 mg (After CP)     Placebo -> Ustekinumab 90 mg (After CP)     Ustekinumab 45 mg (After CP)     Ustekinumab 90 mg (After CP)  
STARTED     255 [1]   255 [1]   256 [1]   0 [2]   0 [2]   0 [2]   0 [2]
COMPLETED     243     254     245     0     0     0     0  
NOT COMPLETED     12     1     11     0     0     0     0  
Adverse Event                 6                 0                 2                 0                 0                 0                 0  
Lack of Efficacy                 3                 0                 1                 0                 0                 0                 0  
Lost to Follow-up                 1                 0                 1                 0                 0                 0                 0  
Randomized but not treated                 0                 0                 1                 0                 0                 0                 0  
Not specified                 2                 1                 6                 0                 0                 0                 0  
[1] Number of patients randomized
[2] "0" in column indicates this reporting group is not relevant to Controlled Period.

Period 2:   After Controlled Period
    Placebo (CP)     Ustekinumab 45 mg (CP)     Ustekinumab 90 mg (CP)     Placebo -> Ustekinumab 45 mg (After CP)     Placebo -> Ustekinumab 90 mg (After CP)     Ustekinumab 45 mg (After CP)     Ustekinumab 90 mg (After CP)  
STARTED     0 [1]   0 [1]   0 [1]   123     120     254     245  
COMPLETED     0     0     0     87     85     172     173  
NOT COMPLETED     0     0     0     36     35     82     72  
Adverse Event                 0                 0                 0                 7                 8                 23                 21  
Death                 0                 0                 0                 1                 2                 0                 1  
Lack of Efficacy                 0                 0                 0                 10                 6                 28                 15  
Lost to Follow-up                 0                 0                 0                 5                 8                 9                 10  
Not specified                 0                 0                 0                 13                 11                 22                 25  
[1] "0" in column indicates this reporting group is not relevant to after Controlled Period.



  Baseline Characteristics
  Hide Baseline Characteristics

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 Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
Ustekinumab 45 mg Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
Ustekinumab 90 mg Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
Total Total of all reporting groups

Baseline Measures
    Placebo     Ustekinumab 45 mg     Ustekinumab 90 mg     Total  
Number of Participants  
[units: participants]
  255     255     256     766  
Age  
[units: Years]
Mean ± Standard Deviation
  44.8  ± 11.32     44.8  ± 12.48     46.2  ± 11.27     45.3  ± 11.71  
Gender  
[units: participants]
       
Female     72     80     83     235  
Male     183     175     173     531  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.   [ Time Frame: Week 12 ]

2.  Secondary:   Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12   [ Time Frame: Baseline (Week 0), Week 12 ]

4.  Secondary:   Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52   [ Time Frame: Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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 event (NAE) excludes patients who only had NAE that occured in <=5% of patients. This information may vary from existing approved labeling and publications due to the requirements of this website.


  More Information
  Hide More Information

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: Dir. Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399


No publications provided by Centocor Research & Development, Inc.

Publications automatically indexed to this study:

Responsible Party: Centocor Research & Development, Inc.
ClinicalTrials.gov Identifier: NCT00267969     History of Changes
Obsolete Identifiers: NCT01585714
Other Study ID Numbers: CR006328, C0743T08, 2005-003529-15
Study First Received: December 20, 2005
Results First Received: October 23, 2009
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration