Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Must be diagnosed with AOSD according to preliminary classification by Yamaguchi (1992).

• Other diseases with similar symptoms must be excluded. Has been exposed to a corticosteroid for ≥2 months prior to randomization for AOSD.

• Needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator.

• Anti-TNF agents must be discontinued 4 to 8 weeks prior to commencing study medication.

Exclusion Criteria:

• Use of corticosteroids (prednisolone equivalent <10 mg/day.

• History of recurrent or chronic infection, including:

• tuberculosis

• any malignancy

• any other major chronic inflammatory disease syndrome

• drug or alcohol abuse

• known positivity for hepatitis B, C or HIV.

• Use of anti-TNF agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.