The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis
- Conditions
- rheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON47583
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 286
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.
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;
(temporary exclusion)
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* To measure benefit, primary endpoints are a) signs and symptoms: the<br /><br>time-averaged mean value (estimated from linear mixed models) of the DAS28; b)<br /><br>damage progression: change from baseline after 2-years in total Sharp/van der<br /><br>Heijde damage score of hands and forefeet radiographs.<br /><br>* To measure safety, the primary endpoint is the total number of patients<br /><br>experiencing at least one serious adverse event, or one clinical event related<br /><br>to the disease or its therapy.<br /><br>* Other major outcomes are cost-effectiveness, cost-utility, and medication<br /><br>adherence.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>