CT-P13 Compared With Remicade When Co-administered With Methotrexate

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

• IRAS ID

  47583

• Contact name

  Thomas Sheeran

• Sponsor organisation

  CELLTRION, Inc

• Eudract number

  2010-018646-31

• ISRCTN Number

  N/A

• Research summary

  This is a randomised, double-blind, parallel-group, phase 3 Study on Patients With Active Rheumatoid Arthritis (RA) who are not receiving adequate response to methotrexate alone. This study is sponsored by CELLTRION Inc. The purpose of this study is to investigate if CT-P13 (the drug under investigation) works as effectively and as safely as Remicade (an approved drug for the treatment of rheumatoid arthritis) in both the short term and long term. The study is also investigating the pharmacokinetic similarity (the action of drugs in the body over a period of time) and the pharmacodynamics (the effect a drug has on the body), and overall safety of multiple doses of CT-P13 and Remicade. Approximately 584 patients with active RA will be recruited from approximately 170 centres worldwide. The UK will recruit about 24 participants. Study duration is expected to be 64 weeks; there will be least 11 hospital visits during this time. Male or female patients with active RA who are not receiving an adequate response with methotrexate alone will be considered to participate if they meet all of the inclusion criteria and none of the exclusion criteria. The study will comprise 4 study treatment periods including Screening, Dose-Loading Phase, Maintenance Phase, and the End-of-Study Period (8 weeks after the last dose). The participant will be randomly assigned to receive either: ?½ CT-P13 (the drug being tested at a dose of 3 mg/kg) Or ?½ Remicade (the approved drug that CT-P13 is being compared with at a dose of 3 mg/kg) On treatment days, the participant will receive a 2-hour intravenous infusion of either CT-P13 or Remicade. Participants will undergo procedures including: physical examination, vital signs, TB test, ECG, radiographs, lab tests and questionnaires.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/56

• Date of REC Opinion

  9 Sep 2010

• REC opinion

  Further Information Favourable Opinion