Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
An open, randomized, parallel-group, comparative, multicentre study. Patients on
corticosteroids (plus conventional therapy) will be randomized to receive anakinra
(Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A
or sulphasalazine. Patients enter the study if considered refractory to corticosteroids
(prednisolone equivalent ≥10 mg/day) at the time of randomization.
The randomized phase of the study will be followed by an open-label extension (OLE) phase, to
follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term
treatment with anakinra or one of the study DMARDs or a combination of study drugs for
additional 28 weeks.
Phase:
Phase 2
Details
Lead Sponsor:
Helsinki University University of Helsinki
Collaborators:
Helse Stavanger HF Jyväskylä Central Hospital Kuopio University Hospital Oulu University Hospital Satakunta Central Hospital Tampere University Hospital Turku University Hospital University Hospital, Linkoeping University Hospital, Umeå Uppsala University Hospital
Treatments:
Azathioprine Interleukin 1 Receptor Antagonist Protein Leflunomide Methotrexate