Trial of Ustekinumab with previously treated Psoriatic Arthritis

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Randomized, Double-blind, Placebo controlled trial of Ustekinumab, a Fully Human anti-IL 12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis and Previously Treated with Biologic Anti-TNFa Agent(s)

• IRAS ID

  45530

• Contact name

  Hasan Tahir

• Eudract number

  2009-012265-60

• ISRCTN Number

  not known

• Research summary

  This study will evaluate a new drug called ustekinumab at two dose levels compared with a dummy preparation which looks the same as the test substance. This drug will be tested in subjects with active psoriatic arthritis (PsA), a condition which causes inflammation in and around the joints, usually in people who already have the skin condition psoriasis. The study will enroll approximately 300 subjects. The subjects will be randomly assigned to either treatment with a 45mg dose of ustekinumab, a 90mg dose of ustekinumab or dummy treatment. Subjects assigned to the dummy treatment will transfer at Week 24 to receive ustekinumab at either of the two dose levels with the last dose being administered at Week 40. Subjects in the 45mg/90mg dose groups will recieve ustekinumab at Week 1 with the last dose at Week 40. All subjects will be regularly reviewed to measure the effectiveness of the study drugs from the start of the study through to Week 52. The safety measurements will be continued through to Week 60.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/39

• Date of REC Opinion

  18 Jun 2010

• REC opinion

  Further Information Favourable Opinion