Steroid Induction Regimen for Juvenile Idiopathic Arthritis (JIA)

• Research type

  Research Study

• Full title

  Steroid Induction Regimen for Juvenile Idiopathic Arthritis (JIA)

• IRAS ID

  193147

• Contact name

  Eileen Baildam

• Contact email

  eileen.baildam@alderhey.nhs.uk

• Sponsor organisation

  Alder Hey Children's NHS Foundation Trust Hospital

• Duration of Study in the UK

  0 years, 8 months, 30 days

• Research summary

  Juvenile Idiopathic Arthritis (JIA) includes arthritis starting before 17. Arthritis means joint inflammation with pain, stiffness, swelling and warmth, causing damage and reduced movement.
  Treatments include anti-inflammatory, disease modifying drugs, and new ‘biologic’ drugs. Patients often still need steroids at the start of treatment or with arthritis flares. Steroids are given: by injection into joints (intra-articular), into veins (intra-venous), into muscle (intramuscular depot) or taken by mouth (oral). There is no agreement about the best way. Steroids are used in many trials of biologic drugs but only one study has directly compared two steroid preparations (in joint injections). We need to know best way to give steroids for the shortest time as they have many side effects.
  Study Aims:
  • Identifying the best steroid treatments to compare in a future study (trial) and the best outcomes to measure
  • Assessing whether parents, patients and health care professionals (HCPs) would be willing and able to randomly allocate (like tossing a coin) patients to treatments
  • Assessing whether enough patients are treated each year to be included in a trial
  • Recommendation on feasible of a national trial

  Methods
  1) A search of published research
  2) A UK-wide study of practice of HCP’s current use
  3) A national survey of treatments
  4) Interviews with patients and parents to consider the design of a future trial
  5) A consensus process: to gain agreement over study protocol, and outcome measures.
  6) A small multi-centre observational study of the type of patients planned in a future trial receiving the proposed steroid treatments, observing changes in the agreed outcomes over a 3 month period. We will calculate numbers of patients needed for a future trial and decide whether a definitive trial, helping us to decide the best steroid plan to use, is possible.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  16/NE/0047

• Date of REC Opinion

  18 Mar 2016

• REC opinion

  Further Information Favourable Opinion