Ustekinumab in psoriatic arthritis CNTO1275PSA3001

• 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

• IRAS ID

  31158

• Contact name

  Hasan Tahir

• Sponsor organisation

  Centocor B.V.

• Eudract number

  2009-012264-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will assess the effect of the new drug ustekinumab in subjects who have active psoriatic arthritis despite current or previous disease treatment with modifying antirheumatic drugs (DMARDs) and/or nonsteroidal anti-inflammatory drugs (NSAIDs). Approximately 600 subjects aged 18 to 99 years (excluding pregnant or nursing women, and men and women planning a pregnancy) will be randomly allocated to one of three groups who will receive treatment with ustekinumab at a dose of 45 mg or 90 mg, or placebo. Ustekinumab will be given by subcutaneous injection at Weeks 0 and 4 and followed by repeat dosing every 12 weeks with the last dose at Week 88. Subjects randomised to placebo will crossover to active therapy at Week 24 and will receive ustekinumab at Weeks 24 and 28 followed by 12 weekly repeat dosing with the last dose at Week 88. Subjects in all three groups are expected to be treated for a total of 100 weeks (approximately 2 years). The effectiveness of ustekinumab will be assessed up to Week 100 and the safety of ustekinumab through to Week 108. ;

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/118

• Date of REC Opinion

  8 Apr 2010

• REC opinion

  Further Information Favourable Opinion