IRIS: Nipocalimab in Active Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy

• IRAS ID

  301176

• Contact name

  David Wright

• Contact email

  scurrie6@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2021-000510-42

• Clinicaltrials.gov Identifier

  NCT04991753

• Duration of Study in the UK

  1 years, 5 months, 25 days

• Research summary

  Summary of Research
  This is a research study in 50 adults with Active Rheumatoid Arthritis despite treatment with standard therapies.

  Rheumatoid Arthritis is a chronic inflammatory disorder of the immune system and affects approximately 1% of the population. Despite treatment options, a large proportion of patients have recurring disease, experience inadequate/intolerant responses to treatments and fail to achieve a low activity of disease.

  The investigational drug is called Nipocalimab. It is a monoclonal antibody designed to bind to a specific part of a receptor molecule involved in recycling IgG. It is hoped by blocking this binding site, IgG cannot be recycled and so circulating levels fall within the body and in turn may lead to less inflammation and a reduction in disease activity. This study is designed to see if Nipocalimab is better than placebo in reducing disease

  This study will last for a maximum of 26 weeks and is divided into 3 parts:
  Screening Phase: 1 or more visits (upto 6 weeks)
  Treatment Phase: 7 visits (12 weeks)
  Safety Follow-Up Phase: 1 visit (8 weeks)

  During study visits a variety of tests will be carried out including, but not limited to, BP, ECG, physical exam, questionnaires and blood samples. Patients will be randomly assigned to receive either Nipocalimab 15mg/kg or Placebo by iv infusion every 2 weeks during the treatment phase. At the end of the treatment phase, participants will complete a final safety follow up visit.

  Summary of Results
  Study participants are provided with a plain language summary in pdf format, expected August 2024

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  21/SC/0269

• Date of REC Opinion

  28 Sep 2021

• REC opinion

  Further Information Favourable Opinion