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Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with juvenile idiopathic arthritis in patients age 12 years and older.

Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with juvenile idiopathic arthritis in patients age 12 years and older. - Dose-to-target of etanercept in patients with JIA age >=12 years

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40793
Enrollment
40
Registered
2014-07-15
Start date
2014-06-05
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

juvenile idiopathic arthritis

Interventions

Patients with Minimal Disease Activity at baseline and with clinically low disease activity for at least 6 months during etanercept treatment will be approached for participation. After inclusion, e

Sponsors

Jan van Breemen Instituut
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosis: JIA, types: polyarthritis (RF negative and RF positive), oligo-arthritis (persistant and extended), psoriasic and enthesitis related arthritis and undifferentiated arthritis (according to the ILAR criteria). • Age 12 years or older. • Treatment with etanercept 50 mg SC weekly (or 25 mg SC twice weekly) or treatment with weekly dose etanercept of 0,8 mg/kg for at least 6 subsequent months. • Minimal Disease Activity, according to the JADAS criteria for Minimal Disease Activity at baseline and clinically low disease activity according to the rheumatologist for at least 6 months to baseline. • No uveitis for a minimum of 12 months. • No use of systemic corticosteroids or intra-articular steroids for a minimum of 6 months prior to baseline. • Written informed consent by the patient (and if applicable, the parents).

Exclusion criteria

Exclusion criteria: Planned reasons for treatment discontinuation. JIA, type: systemic arthritis.

Design outcomes

Primary

MeasureTime frame
To determine the proportion of patients with JIA maintaining Minimal Disease Activity after dose interval prolongation of etanercept.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)