AMC STOP study.

Recruiting

• Conditions: Reumatoide Artritis/ Rheumatoid Arthritis

• Registration Number: NL-OMON28468
• Lead Sponsor: AMC

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. 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;

2. Patients in ARA functional classes I, II, and III may be included;

Exclusion Criteria

1. The use of oral/ intra-articular corticosteroids within 6 months prior to baseline;

2. Pregnancy;

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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