Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
- Conditions
- ankylosing spondylitispsoriatic arthritisrheumatoid arthritis10003816
- Registration Number
- NL-OMON38584
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
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.
Planned reasons for treatment discontinuation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters: Minimal Disease Activity define whether a patient is<br /><br>suitable for inclusion and randomisation. Definition of Minimal Disease<br /><br>Activity is specified for every disease separately. Etanercept serum<br /><br>concentrations, disease activity and cost related parameters will be measured<br /><br>during follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>cost-effectiveness<br /><br>the risk of adverse events.<br /><br>etanercept trough levels </p><br>