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 (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01059773
First received: January 28, 2010
Last updated: May 13, 2014
Last verified: May 2014
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
UST / MTX Stopped Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
UST / MTX Gradually Withdrawn Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.

Participant Flow:   Overall Study
    UST / MTX Stopped     UST / MTX Gradually Withdrawn  
STARTED     244     245  
COMPLETED     224 [1]   221 [1]
NOT COMPLETED     20     24  
Adverse Event                 2                 2  
Withdrawal by Subject                 1                 5  
Lost to Follow-up                 1                 1  
Pregnancy                 1                 1  
Protocol Violation                 6                 2  
Physician Decision                 5                 4  
Lack of Efficacy                 3                 3  
Death                 0                 1  
Malignancy including squamous cell skin                 0                 1  
Ineligible follow TB screening criteria                 0                 1  
Unknown                 1                 3  
[1] Completed is refering to no Discontinuation of Study Agent Through Week 52



  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.
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Reporting Groups
  Description
UST / MTX Stopped Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
UST / MTX Gradually Withdrawn Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
Total Total of all reporting groups

Baseline Measures
    UST / MTX Stopped     UST / MTX Gradually Withdrawn     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]
     
18-29     29     20     49  
30-39     57     48     105  
40-49     69     75     144  
50-59     56     60     116  
>=60     33     42     75  
Gender  
[units: participants]
     
Female     74     83     157  
Male     170     162     332  
Weight, Categorized  
[units: participants]
     
<= 100 kg     195     196     391  
> 100 kg     49     49     98  



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

2.  Secondary:   Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period   [ Time Frame: at week 12, 16, 28 40 and 52 ]

3.  Secondary:   Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period   [ Time Frame: at week 12, 16, 28 40 and 52 ]

4.  Secondary:   Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)   [ Time Frame: at week 12, 16, 28 40 and 52 ]

5.  Secondary:   Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline   [ Time Frame: at Weeks 0, 2, 4, 12, 16, 28, 40 and 52 ]

6.  Secondary:   Proportion of Patients Achieving PASI 50 Response   [ Time Frame: at Weeks 2, 4, 12, 16, 28, 40 and 52 ]

7.  Secondary:   Proportion of Patients Achieving PASI 75 Response   [ Time Frame: at Weeks 2, 4, 12, 16, 28, 40 and 52 ]

8.  Secondary:   Proportion of Patients Achieving PASI 90 Response   [ Time Frame: at Weeks 2, 4, 12, 16, 28, 40 and 52 ]

9.  Secondary:   Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period   [ Time Frame: at week 12, 16, 28 40 and 52 ]
Results not yet reported.   Anticipated Reporting Date:   08/2012   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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: EMEA THERAPEUTIC AREA LEADER
Organization: Janssen-Cilag France
phone: +33 6 15167408


No publications provided


Responsible Party: Janssen-Cilag International NV
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: May 13, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: Ethics Commission