Phase 2 CDP6038 ACTIVE RHEUMATOID ARTHRITIS

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITH AN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY

• IRAS ID

  64646

• Contact name

  Costantino Pitzalis

• Sponsor organisation

  Schwarz Biosciences, Inc.

• Eudract number

  2010-020839-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a 12 week, dose-ranging, double blind, placebo controlled, randomised study to evaluate the efficacy and safety of CDP6038 in subjects with moderately- to severely-active rheumatoid arthritis (RA) who have previously failed tumor necrosis factor (TNF)-blocker therapy and are on a stable dose of methotrexate (MTX)This is a multicenter study and the plan is to randomise 220 subjects. Eligible subjects will be randomised to 1 of 9 treatment groups including CDP6038 60mg, 120mg, or 240mg or placebo administered subcutaneously (sc) every 2 weeks (q2w) or every 4 weeks (q4w) or tocilizumab (TCZ) 8mg/kg (up to a maximum dose of 800mg)administered intravenously (iv) q4w.An open-label extension study Protocol RA0057 will be available for enrolment to subjects who complete the Week 12 Visit of this study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/99

• Date of REC Opinion

  25 Feb 2011

• REC opinion

  Further Information Favourable Opinion