Rheumatoid Arthritis
Conditions
Interventions
666 patients stop their TNF blocking therapy, the other 333 continue.
Sponsors
NVR
Eligibility
Inclusion criteria
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; 3. Low disease activity (DAS28<3.2 measured at least twice) for at least 6 months; 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: There are no exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. What is the difference between both groups in the proportion of patients who are treated with TNF blocking therapy after one year; 2. What is the difference in medical costs/effectiveness of stopping TNF blocking therapy versus continuing; 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; 4. Is the treatment effect modified by disease duration, sex, smoking or anti-CCP; 5. In the stop group: How much time until restart of TNF blocking therapy; 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; 7. In the stop group: Determine whether the TNF blocking therapy is as effective after restart as it was before stopping TNF blocking therapy. | — |
Contacts
Public ContactP.L.C.M. Riel, van
Department of Rheumatology (470) Radboud University Nijmegen Medical Centre PObox 9101
Outcome results
None listed