Clinical trial NCT01083160: 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
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Anti-TNF
Adalimumab
Infliximab
Etanercept
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: DAS28 (Disease Activity Score in 28 Joints)
timeFrame: Baseline and Weeks 8,16 and 24
measure: Tender Joint Count and Swollen Joint Count
timeFrame: Baseline and Weeks 8,16 and 24
measure: Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)
timeFrame: Baseline and Weeks 8,16 and 24
Secondary outcomes:
measure: Evaluate the Compliance and Clinical Tolerability With Adalimumab
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Chihuahua
country: Mexico
facility: Site Reference ID/Investigator# 27882
city: Chihuahua
country: Mexico
facility: Site Reference ID/Investigator# 27883
city: Culiacán Sin.
country: Mexico
facility: Site Reference ID/Investigator# 27884
city: Guadalajara, Jal.
country: Mexico
facility: Site Reference ID/Investigator# 27888
city: Guadalajara, Jal.
country: Mexico
facility: Site Reference ID/Investigator# 27886
city: Guadalajara, Jal.
country: Mexico
facility: Site Reference ID/Investigator# 27887
city: Leon, Gto.
country: Mexico
facility: Site Reference ID/Investigator# 25943
city: Mexico City,
country: Mexico
facility: Site Reference ID/Investigator# 27885
city: Mexico City
country: Mexico
facility: Site Reference ID/Investigator# 28059
city: Puebla, Pue.
country: Mexico
facility: Site Reference ID/Investigator# 27890
city: Puebla, Pue.
country: Mexico
facility: Site Reference ID/Investigator# 27889
city: Tuxtla Gutierrez
country: Mexico
facility: Site Reference ID/Investigator# 28057
Study officials:
affiliation: Abbott
name: Juan Pozos, MD
role: STUDY_CHAIR
References: