Clinical Outcomes, Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab in Patients With Active Rheumatoid Arthritis (RA). A Multicenter Post-Marketing Observational Study in Routine Clinical Use (FALLA)
|ClinicalTrials.gov Identifier: NCT01083160|
Recruitment Status : Terminated (The study was terminated due to low enrollment because inclusion criteria are obsolete.)
First Posted : March 9, 2010
Results First Posted : January 2, 2012
Last Update Posted : January 19, 2012
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.
|Condition or disease|
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.
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||82 participants|
|Official Title:||Clinical Outcomes,Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab. A Multicenter Post-Marketing Observational Study in Routine Clinical Use|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Non responders to other anti-TNF
Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
- DAS28 (Disease Activity Score in 28 Joints) [ Time Frame: Baseline and Weeks 8,16 and 24 ]The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented.
- Tender Joint Count and Swollen Joint Count [ Time Frame: Baseline and Weeks 8,16 and 24 ]The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.
- Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) [ Time Frame: Baseline and Weeks 8,16 and 24 ]Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.
- Evaluate the Compliance and Clinical Tolerability With Adalimumab [ Time Frame: Baseline to Week 24 ]To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083160
|Site Reference ID/Investigator# 27882|
|Chihuahua, Mexico, 31000|
|Site Reference ID/Investigator# 27883|
|Chihuahua, Mexico, 31200|
|Site Reference ID/Investigator# 27884|
|Culiacán Sin., Mexico, 80000|
|Site Reference ID/Investigator# 27888|
|Guadalajara, Jal., Mexico, 44320|
|Site Reference ID/Investigator# 27886|
|Guadalajara, Jal., Mexico, 44650|
|Site Reference ID/Investigator# 27887|
|Guadalajara, Jal., Mexico, 44670|
|Site Reference ID/Investigator# 25943|
|Leon, Gto., Mexico, 37000|
|Site Reference ID/Investigator# 27885|
|Mexico City,, Mexico, 06700|
|Site Reference ID/Investigator# 28059|
|Mexico City, Mexico, 03100|
|Site Reference ID/Investigator# 27890|
|Puebla, Pue., Mexico, 72000|
|Site Reference ID/Investigator# 27889|
|Puebla, Pue., Mexico, 72570|
|Site Reference ID/Investigator# 28057|
|Tuxtla Gutierrez, Mexico, 29000|
|Study Chair:||Juan Pozos, MD||Abbott|