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About
The purpose of this trial is to assess the effect of two Intensive Outpatient Management Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid Arthritis (RA) that are treated with adalimumab.
This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial. A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites across Canada.
Full description
Background:
Rheumatoid arthritis (RA) is chronic systemic inflammatory disease often leading to damage and disability (Lee DM, et al.). RA is associated with a shorter life expectancy (Pincus T, et al.) and, if untreated, can lead to significantly lower quality of life and functional impairment (Bradley EM, et al.).
The concept of tight control, involving the treatment of patients to specified targets with close monitoring and treatment adjustment when necessary, has been trialed in early RA. Many targeted studies have demonstrated improved outcomes or faster target achievement in early RA.
The TICORA trial, which studied a group of patients who had active disease but who had not progressed to multiple DMARDs or biologic therapy, demonstrated that the usage of an intensive outpatient management strategy (IOMS) of RA improved clinical outcomes measures (Grigor C, et al.). Indeed, the results from this clinical trial have shown that strict control and intense follow up, which are based on titration of treatment in accordance to a standardized protocol, improved disease activity, physical function and quality of life of patients without additional cost.
The proposed study will evaluate the application of two types of IOMS. The first IOMS will consist of titration of treatments based on the attainment of a DAS28 score under 2.4 (DAS28-IOMS). The second IOMS will consist of titration of treatment based on the attainment of zero swollen joints (0SJ-IOMS) (28 joints evaluated). Investigators should aim at achieving those targets within a reasonable period of time, i.e. during the first six months of treatment with adalimumab. In addition, investigators should aim at attaining these targets within reasonable limits for each individual patient. The clinical impact of these two IOMS will be compared to that of routine care (RC).
The results of this study will have significant implications not only for the individual subjects but also from the societal perspective since it may enhance the overall real-life effectiveness of the treatments and will identify the best approach to maximize on the benefits of treatment with HUMIRA®.
Primary Objective:
In patients with RA that are initiated on treatment with adalimumab:
Secondary Objectives:
In patients with RA that are initiated on treatment with adalimumab:
Tertiary Study Objectives:
In patients with RA that are initiated on treatment with adalimumab:
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Inclusion criteria
Patient has a diagnosis of rheumatoid arthritis
Patient is > 18 years of age
Patient is naïve to HUMIRA® (adalimumab) therapy.
Patient has access to reimbursement for their standard of care.
If female, patient is either: 1) not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or 2) of childbearing potential and practicing one of the following methods of birth control:
If female and of childbearing potential, patient must have a negative serum pregnancy test performed at Screening.
Patient is able to give written informed consent and to complete the survey requirements.
Exclusion criteria
309 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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