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Table 1 Inclusion and exclusion criteria for participating in the GLORIA trial

From: Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial

Inclusion criteria
 1. Diagnosed with RA according to the 1987 or 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) [17, 18]
 2. Inadequate disease control, as evidenced by a disease activity score of 28 joints (DAS28) ≥ 2.6, calculated with erythrocyte sedimentation rate
 3. Age ≥ 65 years
Exclusion criteria
 1. Having low probability of benefit
  a. Change, stop or start of antirheumatic treatment in the last month prior to eligibility assessment, including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, azathioprine, intramuscular and oral gold, cyclosporine, biologic agents including anti-tumour necrosis factor (TNF), anakinra, abatacept, rituximab, tocilizumab
  b. Treatment with systemic glucocorticoid (GC): oral or parenteral GC with a cumulative prednisolone equivalent dose of 200 mg or higher in the last 3 months.
  c. Treatment with any GC (oral, intra-articular, intravenous or intramuscular) in the last 30 days
 2. Having high probability of harm
  d. Exposure to investigational therapy in the last 3 months
  e. Current participation in another clinical trial
  f. Major surgery, donation, or loss of approximately 500 ml blood within 4 weeks prior to the screening visit
  g. Absolute contraindication to low-dose prednisolone, as determined by the treating physician, such as: uncontrolled chronic infections, diabetes mellitus, hypertension, osteoporosis. When these conditions are under control (e.g. with anti-osteoporosis drugs, antihypertensive drugs) these patients can enter
  h. Absolute contraindication to calcium and/or vitamin D supplement as determined by the treating physician, such as hyperparathyroidism (when insufficiently treated)
  i. Uncontrolled comorbidities, short life span, etc. as determined by the treating physician
 3. Difficulty in measuring benefit/harm
  j. Absolute indication to start with oral or intravenous GC, according to the treating physician
  k. Inability to comply with medical instructions or inability to assess major outcomes
 4. Not capable or willing to provide informed consent
 Most exclusion criteria are temporary