Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT02585258
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02585258
Study Brief:
Protocol Section:
NCT02585258