The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study
Condition: RheumatoId Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Prednisolone; Placebo
Intervention description: 1 capsule containing a tablet of 5 mg prednisolone/ day; 1 capsule containing a placebo tablet / day
Intervention MeSH terms: Prednisolone; Glucocorticoids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 451.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in
      treatment strategies for elderly patients with rheumatoid arthritis:

      The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)
    

Eligibility criteria:

        Population (base) RA patients of 65 years of age and older requiring antirheumatic therapy.

        Inclusion criteria

        In order to be eligible to participate in this study, a subject must meet all of the
        following criteria:

          -  RA according to the 1987 or the 2010 classification criteria of the American College
             of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (Aletaha D et
             al, Ann Rheum Dis 2010;69:1580);

          -  inadequate disease control, as evidenced by a disease activity score of 28 joints
             calculated with erythrocyte sedimentation rate (DAS28) ≥2.60;

          -  age ≥ 65 years.

        Exclusion criteria

        A potential subject who meets any of the following criteria will be excluded from
        participation in this study:

        Lower probability of benefit:

          -  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-tumor necrosis factor (TNF), anakinra, abatacept, rituximab,
             tocilizumab (temporary exclusion);

          -  Treatment with systemic GC: oral or parenteral GC with a cumulative prednisolone
             equivalent dose of 200 mg or higher in the last 3 months;

          -  Treatment with any GC (oral, intra-articular, intravenous or intramuscular) in the
             last 30 days (temporary exclusion);

          -  Note: as this is a pragmatic trial, patients who require start of (other)
             antirheumatic treatment at baseline or during the trial can still be eligible (see
             7.1).

        Higher probability of harm:

          -  Exposure to investigational therapy in the last three months;

          -  Current participation in another clinical trial;

          -  Major surgery, donation or loss of approximately 500 ml blood within 4 weeks prior to
             the screening visit (temporary exclusion)

          -  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 antiosteoporosis
             drugs, antihypertensive drugs) these patients can enter;

          -  Absolute contraindication to Calcium and/or Vitamin D supplement as determined by the
             treating physician, such as: hyperparathyroidism (when insufficiently treated);

          -  Uncontrolled comorbid conditions, short life span, etc. as determined by the treating
             physician.

        Difficulty to measure harm/benefit:

          -  Absolute indication to start with oral or intravenous GC, according to the treating
             physician;

          -  Inability to comply with medical instructions or inability to assess major outcomes at
             6-monthly visits, in the assessment of the treating physician.

        Subjects/patients not capable or willing to provide informed consent.

        Substudy

        Additional exclusion criteria for subjects participating in the substudy to measure the
        effect of a reminder via smart device on adherence:

        Inability/difficulty to measure benefit:

          -  Not in the possession of a smart device;

          -  Premature discontinuation of study medication within or at 3 months of the main trial.