drugset / Trial / NCT00726804

Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis

NCT00726804

Phase 4 Terminated 7 enrolled Glostrup University Hospital, Copenhagen
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha antagonist therapy is costly, implies an increased risk of infections, including reactivation of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in SpA patients without immediate relapse of disease activity. Two studies have investigated discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing spondylitis, reporting flares in the majority of patients within the 1-year follow-up period, with the longest times to relapse in patients with the lowest disease activity. The effect of adalimumab discontinuation has never been studied, and, furthermore, the effect of TNF-alpha-antagonist discontinuation has never been studied in patients with early spondyloarthritis not fulfilling the New York criteria.

Timeline

Start
2008-03
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Other
Subject Etanercept Protein / enzyme biologic 25 mg Other
Subject Infliximab Monoclonal antibody 3 mg/kg Other
Subject Infliximab Monoclonal antibody 5 mg/kg Other

Indications