A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate (TRANSIT)

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01059773
First received: January 28, 2010
Last updated: March 13, 2012
Last verified: March 2012
Results First Received: December 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Ustekinumab
Drug: Methotrexate

  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
No text entered.

Reporting Groups
  Description
Immediate Methotrexate Cessation Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Gradual Reduction of Methotrexate Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.

Participant Flow:   Overall Study
    Immediate Methotrexate Cessation     Gradual Reduction of Methotrexate  
STARTED     244     245  
COMPLETED     240 [1]   241 [1]
NOT COMPLETED     4     4  
Adverse Event                 2                 1  
Pregnancy                 1                 0  
Protocol Violation                 0                 1  
Physician Decision                 1                 1  
Other                 0                 1  
[1] Completed is referring to no Discontinuation of Study Agent within the First 12 Weeks



  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
Immediate Methotrexate Cessation Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Gradual Reduction of Methotrexate Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
Total Total of all reporting groups

Baseline Measures
    Immediate Methotrexate Cessation     Gradual Reduction of Methotrexate     Total  
Number of Participants  
[units: participants]
  244     245     489  
Age  
[units: years]
Mean ± Standard Deviation
  45.1  ± 12.1     47.3  ± 12.6     46.2  ± 12.4  
Age, Customized  
[units: participants]
     
18-30     32     22     54  
31-45     92     89     181  
46-55     70     67     137  
56-65     40     47     87  
>65     10     20     30  
Gender  
[units: participants]
     
Female     74     83     157  
Male     170     162     332  
Body Weight at baseline  
[units: participants]
     
<= 100 kg     195     196     391  
> 100 kg     49     49     98  



  Outcome Measures

1.  Primary:   Number of Patients Experiencing One or More Adverse Events Occuring From Week 0 Through Week 12   [ Time Frame: from week 0 to week 12 ]

2.  Secondary:   Efficacy of Study Drug Measured Using Psoriasis Area & Severity Index (PASI) and Physician's Global Assessment (PGA)   [ Time Frame: 52 weeks ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No

3.  Secondary:   Quality of Life as Measured by Changes in Dermatology Life Quality Index (DLQI), EuroQol-5D (EQ-5D) and Patient Benefit Index (PBI)   [ Time Frame: 52 weeks ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No

4.  Secondary:   Rate of Adverse Events   [ Time Frame: 52 Weeks ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No

5.  Secondary:   Rate of AEs, Reasonably Related AEs/SAEs and Treated Infections   [ Time Frame: each visit from week 0 to 52 ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No

6.  Secondary:   Rate of Malignancies   [ Time Frame: each visit from week 0 to week 52 ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No

7.  Secondary:   Change in Mean/Median PASI Score Conpared to Baseline   [ Time Frame: at week 0, 2, 4, 12, 16, 28, 40 and 52 ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Lead, Immunology, Neuro & Pain
Organization: Janssen-Cilag UK
phone: +44 1494 567839


No publications provided


Responsible Party: Medical Lead, Immunology, Neuro & Pain, Janssen-Cilag Ltd, United Kingdom
ClinicalTrials.gov Identifier: NCT01059773     History of Changes
Other Study ID Numbers: CR016639, CR016639, CNTO1275PSO4004
Study First Received: January 28, 2010
Results First Received: December 22, 2011
Last Updated: March 13, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: Ethics Commission