Long-Term Efficacy & Safety of CT-P13 in Rheumatoid Arthritis patients

• Research type

  Research Study

• Full title

  An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

• IRAS ID

  94770

• Contact name

  Thomas Sheeran

• Sponsor organisation

  CELLTRION, Inc

• Eudract number

  2011-004468-31

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, affecting 1% of the world??s population and approximately 400,000 people in the UK. The purpose of this open label extension study is to see if CT-P13 (an unlicensed drug) works effectively and safely in the long term when given in multiple single doses. Approximately 617 rheumatoid arthritis patients who have already completed the CT-P13 3.1 study will be recruited into this study worldwide. Each participant will be in this study for approximately 56 weeks. CT-P13 belongs to a group of drugs called anti-TNFs (anti-tumour necrosis factor). In people with rheumatoid arthritis, and other inflammatory diseases such as ankylosing spondylitis (AS, chronic inflammation of the spine), a protein called TNF is overproduced, causing inflammation and damage to bones, cartilage and tissue. Anti-TNF drugs block the action of TNF and so can reduce this inflammation. CT-P13 is biosimilar to an approved drug called Remicade, it is expected to work in the same way and have the same side effects. In the 3.1 study, participants would have been taking either CT-913 or Remicade. At the end of the 3.1 study, participants interested in joining this extension study will be asked to give their consent to either switch to or continue taking CT-P13. In this study all participants will receive CT-P13 at a dose of 3 mg/kg. Participants will also take methotrexate (12.5 to 25 mg/week, at the same dose as the CT-P13 3.1 study) and folic acid (=5 mg/week, oral dose). On each day of treatment, participants will receive a single 2-hour IV (intravenous) infusion of CT-P13. Participants will receive further study drug treatments every 8 weeks. Participants will undergo procedures including: physical examination, vital signs, TB test, ECG, radiographs, lab tests and questionnaires.This study is sponsored by CELLTRION Inc.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0868

• Date of REC Opinion

  20 Dec 2011

• REC opinion

  Favourable Opinion