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

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.

Conditions

• Adult-Onset Still's Disease

Interventions

DRUG

anakinra

100 mg subcutaneous injection daily

DRUG

comparators

po drugs, comparators

Sponsors & Collaborators

• Uppsala University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Tampere University Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Oulu University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Jyväskylä Central Hospital

  collaborator OTHER

• Satakunta Central Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• University of Helsinki

  lead OTHER

Principal Investigators

• Dan C Nordstrom, MD, PhD · Helsinki University Hospital, Department of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2010-03-31

Completion

2010-04-30

Countries

• Sweden

Study Locations