REACT

• Research type

  Research Study

• Full title

  REmission induction of Arthritis caused by Cancer ImmunoTherapy (REACT): A Randomised, Multicentre Trial to Guide Initial Therapy for Immune Checkpoint Inhibitor-induced Inflammatory Arthritis

• IRAS ID

  1009034

• Contact name

  Benjamin Fisher

• Contact email

  b.fisher@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• ISRCTN Number

  ISRCTN18217497

• Research summary

  Immune Checkpoint Inhibitors (ICI) are drugs that block ‘off’ signals in our immune system to help it fight cancer. A side effect of ICI treatment is that inflammation may occur in parts of the body unrelated to the cancer such as the joints (arthritis). ICI induced arthritis affects at least 5% of treated cancer patients and has a big impact upon quality of life. It may persist even after the ICI is stopped and may require treatment with drugs to suppress the immune system. The typical approach is to start with ‘steroid’ tablets (prednisolone) then gradually try other treatments if these fail with a ‘trial and error’ approach.
  Aim: To compare treatment by an anti-TNF (adalimumab) drug used first-line, to current standard of care starting with prednisolone.
  Methods: The best treatment strategy can only be established through clinical trials that allocate patients by chance to different treatments. We will recruit patients with ICI-induced inflammatory arthritis (ICI-IA), for whom the treating doctors would prescribe Prednisolone. Participants will be either given standard of care (prednisolone) or adalimumab. Treatments will be gradually reduced once the arthritis is controlled, or further treatment given if needed. We will compare the proportion of patients in each treatment group who have no arthritis and no steroid use at 24 weeks and 48 weeks. We will also compare how fast the arthritis is controlled. We will continue to follow patients until 48 weeks to compare arthritis activity, quality of life, ability to function, total amount of immunosuppressive drugs received over time, number of ICI doses missed, new immune-related side effects, cancer outcomes and survival.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  24/EM/0202

• Date of REC Opinion

  31 Oct 2024

• REC opinion

  Further Information Favourable Opinion