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

Rheumatoid Arthritis Clinical Trial

— FALLA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01083160
• Other study ID #: P10-604
• Status: Terminated
• Phase: N/A
• First received: February 19, 2010
• Last updated: January 17, 2012
• Start date: April 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

1. =3 tender joints and =3 swollen joints, or

2. DAS 28 score >3.1

• Patients who are discontinuing treatment with either infliximab or etanercept due to:

1. Lack of efficacy, or

2. Incomplete response.

• 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:

• Patients who have active infections.

• Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray.

• Patients participating into another study or clinical trial

• Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Mexico	Site Reference ID/Investigator# 27882	Chihuahua
Mexico	Site Reference ID/Investigator# 27883	Chihuahua
Mexico	Site Reference ID/Investigator# 27884	Culiacán Sin.
Mexico	Site Reference ID/Investigator# 27886	Guadalajara, Jal.
Mexico	Site Reference ID/Investigator# 27887	Guadalajara, Jal.
Mexico	Site Reference ID/Investigator# 27888	Guadalajara, Jal.
Mexico	Site Reference ID/Investigator# 25943	Leon, Gto.
Mexico	Site Reference ID/Investigator# 28059	Mexico City
Mexico	Site Reference ID/Investigator# 27885	Mexico City,
Mexico	Site Reference ID/Investigator# 27889	Puebla, Pue.
Mexico	Site Reference ID/Investigator# 27890	Puebla, Pue.
Mexico	Site Reference ID/Investigator# 28057	Tuxtla Gutierrez

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28 (Disease Activity Score in 28 Joints)	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.	Baseline and Weeks 8,16 and 24	No
Primary	Tender Joint Count and Swollen Joint Count	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.	Baseline and Weeks 8,16 and 24	No
Primary	Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)	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.	Baseline and Weeks 8,16 and 24	No
Secondary	Evaluate the Compliance and Clinical Tolerability With Adalimumab	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.	Baseline to Week 24	Yes