ankylosing spondylitis psoriatic arthritis rheumatoid arthritis
Conditions
Interventions
Phase 1: Patients with low disease activity will be randomly assigned to
continuation of etanercept 50 mg per week or etanercept 50 mg per two weeks.
Patietns will be followed for 6 months.
Phase 2
Sponsors
Jan van Breemen Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis: Rheumatoid Arthritis (according to the American College of Rheumatology 1987 criteria), or Psoriatic Arthritis (according to the Classification of Psoriatic Arthritis criteria) or Ankylosing spondylitis (according to the 1984 New York Criteria). Treatment with etanercept 50 mg subcutaneously (SC) weekly (or 25 mg SC twice weekly) for at least 6 subsequent months. Minimal Disease Activity (MDA): Outcome Measures in Rheumatology (OMERACT) MDA criteria for RA, MDA criteria for PsA which are defined in collaboration with the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Ankylosing Spondylitis Disease Activity Score (ASDAS), using C-reactive protein (CRP), inactive or moderate disease activity. Written informed consent.
Exclusion criteria
Exclusion criteria: Planned reasons for treatment discontinuation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters: Minimal Disease Activity define whether a patient is suitable for inclusion and randomisation. Definition of Minimal Disease Activity is specified for every disease separately. Etanercept serum concentrations, disease activity and cost related parameters will be measured during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| cost-effectiveness the risk of adverse events. etanercept trough levels | — |
Countries
Netherlands
Outcome results
None listed