TRANSIT: SAFETY AND EFFICACY IN PATIENTS TRANSITIONED TO USTEKINUMAB

• Research type

  Research Study

• Full title

  An exploratory TRial to Assess Naturalistic Safety and efficacy outcomes In patients Transitioned to ustekinumab from previous methotrexate therapy (TRANSIT)

• IRAS ID

  21209

• Eudract number

  2008-008171-34

• ISRCTN Number

  Not applicable

• Research summary

  Patients eligible for the study will be those who have moderate to severe plaque psoriasis and have either not been helped by, or find it difficult to tolerate, methotrexate therapy. Patients entering the study will have been receiving methotrexate at a minimum dose of 10 mg/week for at least 8 weeks prior to screening. Approximately 500 patients will be included in the study from about 100 sites in 20 countries. Patients will be randomly assigned to different treatment schedules but the study will be "open", that is both patients and their treating physicians will be aware of which treatment schedule they are assigned to receive. During the Screening Phase, patients will continue their current methotrexate regimen. Prior to the first dose of ustekinumab, patients will be randomised in equal numbers to one of two treatment arms: Arm 1: Immediate cessation of methotrexate therapy and administration of subcutaneous ustekinumab Arm 2: Gradual reduction of methotrexate therapy over a maximum of 4 weeks and administration of subcutaneous ustekinumab In both treatment arms, patients weighing =100 kg will receive ustekinumab 45 mg at Weeks 0, 4 and every 12 weeks thereafter until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg at Weeks 0, 4 and every 12 weeks thereafter until Week 40. The primary endpoint, assessed at Week 12, is the proportion of patients experiencing one or more treatment-emergent adverse events. All treated patients will be followed for safety and efficacy until Week 52.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  09/H0808/68

• Date of REC Opinion

  13 Oct 2009

• REC opinion

  Further Information Favourable Opinion