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)

Abbott

Status: Terminated

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01083160

P10-604

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 1 patient group

Non responders to other anti-TNF

Description:

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.