CDP6038 rheumatoid arthritis, open label follow up study

• Research type

  Research Study

• Full title

  A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056

• IRAS ID

  64651

• Contact name

  Costantino Pitzalis

• Sponsor organisation

  Schwarz Biosciences, Inc.

• Eudract number

  2010-022224-77

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  RA0057 is a long-term open-label extension study to RA0056: a 12-week double-blind placebo- and active-controlled, Phase 2b dose-ranging study in subjects with moderately to severely active rheumatoid arthritis (RA) who have previously failed tumor necrosis factor alpha (TNFa) blocker therapy and who are on a stable dose of methotrexate (MTX). This study will allow collection of long-term data on the safety and tolerability of CDP6038 in subjects with active RA. In addition, efficacy with respect to signs and symptoms of RA will be assessed over the course of this study. It is anticipated that approximately 190 subjects will be enrolled in this multicenter study. Eligible subjects will enter the study after completing the Week 12 Visit of RA0056 and in the UK will be allowed to continue in this open-label study for a period of 5 years, or until further notice from UCB.All subjects will receive CDP6038 120mg every 2 weeks (q2w) throughout the study, regardless of their treatment assignment in RA0056. Subjects withdrawing from the study will be followed-up at 6 and 12 weeks after the last investigational medicinal product (IMP) administration.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/0057

• Date of REC Opinion

  27 Apr 2011

• REC opinion

  Further Information Favourable Opinion