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)

This study has been terminated.
(The study was terminated due to low enrollment because inclusion criteria are obsolete.)
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01083160
First received: February 19, 2010
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • DAS28 (Disease Activity Score in 28 Joints) [ Time Frame: Baseline and Weeks 8,16 and 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluate the Compliance and Clinical Tolerability With Adalimumab [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 82
Study Start Date: April 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083160

Locations
Mexico
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# 27887
Guadalajara, Jal., Mexico, 44670
Site Reference ID/Investigator# 27886
Guadalajara, Jal., Mexico, 44650
Site Reference ID/Investigator# 27888
Guadalajara, Jal., Mexico, 44320
Site Reference ID/Investigator# 25943
Leon, Gto., Mexico, 37000
Site Reference ID/Investigator# 28059
Mexico City, Mexico, 03100
Site Reference ID/Investigator# 27885
Mexico City,, Mexico, 06700
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
Sponsors and Collaborators
Abbott
Investigators
Study Chair: Juan Pozos, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01083160     History of Changes
Other Study ID Numbers: P10-604
Study First Received: February 19, 2010
Results First Received: November 23, 2011
Last Updated: January 17, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Abbott:
Rheumatoid Arthritis
Anti-TNF
Adalimumab
Infliximab
Etanercept

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
TNFR-Fc fusion protein
Adalimumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 19, 2014