Phase 3 study of CT P13 vs Remicade in patients with Crohn's disease

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

• IRAS ID

  157189

• Contact name

  Ailsa Hart

• Contact email

  ailsa.hart@nhs.net

• Sponsor organisation

  Celltrion, Inc.

• Eudract number

  2013-004497-10

• Clinicaltrials.gov Identifier

  NCT02096861

• Research summary

  This is a Phase 3 study to assess to demonstrate Noninferiotity in Efficacy and safety of CT-P13 compared to Remicade in patients with Active Crohn’s disease. This study is funded by Celltrion, Inc.

  Crohn’s disease is a chronic inflammatory disorder that affects the gastrointestinal tract. To control the symptoms, patients are required to take corticosteroids. However, the side effects of prolonged use off set the benefits of treatment. Tumour necrosis factor-alpha (TNFa) is a protein involved in producing inflammation and important in Crohn’s disease. Infliximab (trade name Remicade) targets TNFa and has shown to cause a reduction in symptoms in patients. Infliximab is a type of medicine knowns as a monoclonal antibody that binds very well to different forms of TNFa and neutralises its biological activity.
  The study drug, CT-P13 is biosimilar to Infliximab. “Biosimilar” means that CT-P13 is highly similar to Infliximab and does not have any significant differences from Infliximab in terms of quality, safety or efficacy. The study is designed to investigate if CT-P13 works effectively and safely in the long term. CT-P13 is an approved medicine by the European Medicines Agency (EMA).

  This is a double- blind, randomised, multi-centre study to demonstrate that CT-P13 is non inferior than Infliximab at week 6 in terms of efficacy. The study plans also to evaluate the long term secondary efficacy of CT-P13 in comparison with Infliximab up to Week 54 and to evaluate the overall safety of CT-P13 in comparison with Infliximab up to Week 54.

  Approximately 214 patients will be enrolled in Europe, Asia, North and South America. The patients will visit the study site at least 11 times over a period 68 weeks with each visit lasting about 5 hours or less. They may also be asked to come in on additional visits for blood collection.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/1392

• Date of REC Opinion

  16 Sep 2014

• REC opinion

  Further Information Favourable Opinion