Advertisement

Topics

Clinical Outcomes Compliance and the Effectiveness of Switching From Infliximab or Etanercept to Adalimumab: A Multicenter Study in Routine Clinical Use

2014-08-27 03:15:23 | BioPortfolio

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 Objective.

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 objectives To evaluate the compliance and clinical tolerability with Adalimumab

Investigational Plan 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Rheumatoid Arthritis

Location

Site Reference ID/Investigator# 27882
Chihuahua
Mexico
31000

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:23-0400

Clinical Trials [1302 Associated Clinical Trials listed on BioPortfolio]

Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis

Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis. Secondary aim: Evaluate cardiovascular ris...

Safety Study of Abatacept to Treat Rheumatoid Arthritis

The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are tre...

Activity Limitations in Rheumatoid Arthritis

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Hea...

Rosuvastatin in Rheumatoid Arthritis (RORA)

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called ...

A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by patients with the disease.

PubMed Articles [1152 Associated PubMed Articles listed on BioPortfolio]

The genetic profile of RF-positive polyarticular juvenile idiopathic arthritis (JIA) resembles adult rheumatoid arthritis (RA).

Juvenile idiopathic arthritis (JIA) is comprised of seven heterogeneous categories of chronic childhood arthritides. About 5% of children with JIA have rheumatoid factor (RF) positive arthritis, which...

MICB*002 and MICB*014 protect against rheumatoid arthritis, whereas MICA*009 and MICA*A6 are associated with rheumatoid arthritis in a Hainan Han Chinese population.

Rheumatoid arthritis (RA) as an inflammatory autoimmune disease affects the synovial joints as well as other organs and tissues. Since aberrant expression of MIC molecules has been observed in RA pati...

Treatment of chronic chikungunya arthritis with methotrexate: a systematic review.

Chikungunya is a rapidly emerging, global viral infection that can cause chronic, debilitating arthritis that in some ways mimics rheumatoid arthritis. This study evaluated the available evidence of t...

What are the dominant cytokines in early rheumatoid arthritis?

Rheumatoid arthritis is a systemic disease of evolving immune dysregulation that culminates in joint destruction and disability. The principle by which pro-inflammatory cytokines may be therapeuticall...

Increased Burden of Psychiatric Disorders in Rheumatoid Arthritis.

We estimated the incidence and prevalence of depression, anxiety disorder, bipolar disorder and schizophrenia in a population-based cohort with rheumatoid arthritis (RA) as compared to an age-, sex- a...

Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.

Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.

Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.

More From BioPortfolio on "Clinical Outcomes Compliance and the Effectiveness of Switching From Infliximab or Etanercept to Adalimumab: A Multicenter Study in Routine Clinical Use"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Orthopedics
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...


Searches Linking to this Trial