Potential Optimalisation of (Expediency) and Effectiveness of TNF-blockers.
Recruiting
- Conditions
- Rheumatoid Arthritis
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
1. Diagnosis Rheumatoid Arthritis according to the 1987 ACR criteria;
2. At least 1 year of treatment with TNF blocking therapy and at least 6 months of stable DMARD treatment;
Exclusion Criteria
There are no exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the percentage of patients who experience an exacerbation of RA during the first year. Exacerbation is defined as a Disease Activity Score of 28 joint (DAS28) above 3.2 with a DAS28 increase of above 1.2
- Secondary Outcome Measures
Name Time Method 1. What is the difference between both groups in the proportion of patients who are treated with TNF blocking therapy after one year;<br /><br>2. What is the difference in medical costs/effectiveness of stopping TNF blocking therapy versus continuing;<br /><br>3. What is the difference between both groups in the DAS28, number of patients with a DAS28<2.6, number of patients in remission according to the ACR/EULAR criteria, at 3 months, at 6 months, at 9 months and at 12 months;<br /><br>4. Is the treatment effect modified by disease duration, sex, smoking or anti-CCP;<br /><br>5. In the stop group: How much time until restart of TNF blocking therapy;<br /><br>6. In the stop group: Determining which (combination of) factors predict succesful stopping of TNF blocking therapy, defined as low disease activity without restart of TNF blocking therapy;<br /><br>7. In the stop group: Determine whether the TNF blocking therapy is as effective after restart as it was before stopping TNF blocking therapy.