Efficacy and Safety study of NI-071 and Remicade®(Infliximab) for RA

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

• IRAS ID

  216207

• Contact name

  Masroor Ahmad

• Contact email

  masroor.ahmad@pat.nhs.uk

• Sponsor organisation

  Nichi-Iko Pharmaceutical Co., Ltd

• Eudract number

  2016-001064-11

• Clinicaltrials.gov Identifier

  126520, IND Number

• Duration of Study in the UK

  2 years, 4 months, 0 days

• Research summary

  This is a Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI 071 (investigational product) and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis (RA).

  Approximately 160 sites from the US and western and Eastern Europe are expected to take part and roughly 585 participants, aged between 18 and 75 with active RA will be invited to take part.

  Participants will be screened initially for eligibility and then at baseline (week 0) they will be randomly assigned in a 2:1 ratio to either Remicade-US or NI-071 respectively. This will result in twice as many participants receiving Remicade-US to NI-071.

  At week 22 participants that were randomised to Remicade initially will be re-randomised in a 1:1 ratio to remicade-us and NI-071 (Switch group)

  Participants will take part in this study for 17 months.
  This study has 3 stages
  Stage 1 - Biosimilarity, for 22 weeks
  Stage 2 - Interchangeability, for 32 weeks
  Stage 3 -Safety follow up, for 12 weeks

  Participants will be required to visit the site 22 times in total for the study 17 times for clinic visits and 5 times for blood samples to be taken.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  17/NW/0371

• Date of REC Opinion

  18 Jul 2017

• REC opinion

  Further Information Favourable Opinion