Potential optimalisation of (Expediency) and Effectiveness of TNF-blockers

Recruiting

• Conditions: rheumatoid arthritis; 10003816

• Registration Number: NL-OMON35995
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

•Diagnosis Rheumatoid Arthritis according to the 1987 ACR criteria
•Treated for at least 1 year with a TNF-blocker and stable (no dose changes) DMARD treatment for the preceding 6 months
•Low disease activity for at least 6 months, according to both patient and rheumatologist, and a DAS28<3.2 measured at at least two different time points
•Signed informed consent.

Exclusion Criteria

None

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: the primary outcome measure is the percentage of patients who<br /><br>experience an exacerbation of RA during the first year: increase of DAS28 >3.2<br /><br>with a delta DAS28 of > 1.2.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Number of patients stopped anti-TNF at 12 months<br /><br>Timespan of anti tNF usage, volume and medical costs<br /><br>DAS28 value<br /><br>Percentage of patients with a DAS28<3.2<br /><br>Percentage of patients with a DAS28<2.6<br /><br>Percentage of patients in remission according to ACR/EULAR criteria<br /><br>Occurrence of side effects<br /><br>Patient Satisfaction<br /><br>Function (HAQ questionnaire)<br /><br></p><br>