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