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This is a prospective, single-arm, post marketing observational study in adult patients with active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
Full description
This is a prospective, single-arm, post marketing observational study in adult patients with active RA who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to Adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
Study Objectives:
Primary objective:
To assess the effectiveness of the treatment with adalimumab in patients with rheumatoid arthritis (RA) that have failed or presented an incomplete response to current treatment with either infliximab or etanercept.
Secondary objective:
To evaluate the compliance and clinical tolerability with adalimumab
Investigational Plan and Selection of Study Population:
All patients belonging to any of the centres participating in the study that meet all the inclusion criteria and none of the exclusion criteria will be considered eligible.
Patients considered eligible for the study will have to give their consent for the use and/or disclose of the patient's personal and/or health data. Patient's consent will be obtained before his/her participation in the study and will be documented in an Informed Consent Form approved by an Ethics Committee.
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Inclusion criteria
Patients ≥18 and <75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
Patients with active RA defined as:
Patients who are discontinuing treatment with either infliximab or etanercept due to:
Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
Exclusion criteria
The following patients will not be included in the study:
82 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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