Dose-to-target of etanercept treatment in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Dose-to-target of etanercept treatment: A dose-tapering randomized controlled trial in patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24861

Enrollment

250

Registered

2013-03-14

Start date

2013-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Etanercept, dose-to-target, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, personalized medicine

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:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis: RA (according to the American College of Rheumatology 1987 criteria), or PsA (according to the Classification of Psoriatic Arthritis criteria) or AS (according to the 1984 New York Criteria); 2. Treatment with etanercept 50 mg SC weekly (or 25 mg SC twice weekly) for at least 6 subsequent months; 3. Minimal Disease Activity: 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; 4. Written informed consent.

Exclusion criteria

Exclusion criteria: Planned reasons for treatment discontinuation.

Design outcomes

Primary

Measure	Time frame
To determine the proportion of patients with RA, AS or PsA maintaining Minimal Disease Activity after dose interval prolongation of etanercept.	—

Secondary

Measure	Time frame
1. To study the cost-effectiveness of tapering down etanercept treatment; 2. To investigate whether the lowest effective etanercept dose will reduce the risk of adverse events; 3. To study the predictive value of serum etanercept trough levels and other patient related factors for successful down titration.	—

Contacts

Public ContactG.J. Wolbink

Dr. Jan van Breemenstraat 2, 1065 AB Amsterdam

g.wolbink@reade.nl020-5896 589

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)