Prospective study on the effects of withdrawal of anti-TNF therapy in patients with rheumatoid arthritis who are in remission- stop-study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Men/women suffering from rheumatoid arthritis, based on the 2010 American College of Rheumatology/ European league Against Rheumatism (ACR/EULAR) classification criteria for RA will be included in this study.;Patients in ARA functional classes I, II, and III may be included.;In addition, patients must fulfill the following criteria at baseline:
1) DAS 28 * 2.6 for the duration of a minimum of 24 weeks
2) Be > 18 years of age and * 85 years.
3) Stable use of concomitant DMARDs and TNF antagonists for the duration of 24 weeks before baseline

Exclusion Criteria

1) The use of oral/ intra-articular corticosteroids within 6 months prior to baseline
2) Pregnancy
3) Breastfeeding
4) Subjects who are impaired, incapacitated, or incapable of completing study
related assessments.
5) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
erythematous).
6) Subjects with active vasculitis of a major organ system with the exception of
rheumatoid nodules.
7) Subjects with current symptoms of severe, progressive, or uncontrolled renal,
hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
cerebral disease, or other medical conditions that, in the opinion of the
investigator, might place the subject at unacceptable risk for participation in this
study.
8) Subjects who have clinically significant drug or alcohol abuse.
9) Inability to give informed consent
10) Mental condition rendering the patient unable to understand the na¬ture, scope
and possible consequences of the study and/or evidence of an uncooperative attitude.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is:<br /><br>1. The percentage of patients that sustain drug-free remission 24 months after<br /><br>the cessation of TNF-antagonists<br /><br>2. Predictors (e.g. clinical parameters, serological and immunological markers)<br /><br>of sustained drug-free remission </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The difference in genetic markers/ epigenetic markers (e.g. genetic<br /><br>polymorphisms/ methylation status) in TNF-* genes that predict sustained<br /><br>drug-free remission in the individual patient<br /><br>2. Explore new markers, e.g. by micro-array analysis, distinguishing patients<br /><br>with sustained drug-free remission from patients who relapse.<br /><br>3. Determine the percentage of patients with subclinical synovitis as<br /><br>determined by ultrasound in this group of patients in clinical remission</p><br>