A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis
- Conditions
- Rheumatoid artritisMedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-002729-21-DE
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
RA according to the 1987 or 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (Aletaha D 2010);
Inadequate disease control, as evidenced by a 28-joint disease activity score (DAS28) of = 2.60.
For eligibility, the DAS28 can be calculated with ESR or CRP, and also recalculated from the DAS of 44 joints. A DAS28 may be calculated with clinical and lab assessments obtained no more than 4 weeks before the baseline visit.
age = 65 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450
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-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);
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: a)To assess the effectiveness, safety and cost-effectiveness of 2 years of low-dose GC therapy (5 mg/day) compared to placebo as co-treatment for elderly RA patients in a pragmatic randomized trial<br>b)Study medication adherence through a medication packaging solution, and test the effectiveness of smart device technology to improve adherence<br>;Secondary Objective: not applicable;Primary end point(s): Signs and symptoms: the time-averaged mean value of the DAS28.<br>To measure safety, the primary endpoint is the total number of patients experiencing at least one serious adverse event, or one clinical event related to the disease or its therapy. <br>Other major outcomes are cost-effectiveness, cost-utility, and medication adherence. <br>;Timepoint(s) of evaluation of this end point: Baseline, 3, 6, 12, 18 and 24 months
- Secondary Outcome Measures
Name Time Method