This trial is active, not recruiting.

Condition adult-onset still's disease
Treatment anakinra
Phase phase 2
Sponsor Helsinki University
Collaborator Uppsala University Hospital
Start date December 2005
End date March 2010
Trial size 60 participants
Trial identifier NCT01033656, 2005-003173-24, NordicAOSD05


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
anakinra Interleukin-1 receptor antagonist
100 mg subcutaneous injection daily

Primary Outcomes

Number of patients reaching remission of the disease, after eight weeks of the randomized study treatment (Remission: afebrile and normalization of acute phase reactants)
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open, Randomized Study Treating Refractory Adult-onset Still's Disease With Interleukin-1 Receptor Antagonist Anakinra (Kineret), Compared to an Established, Single Anti-rheumatic Drug Treatment
Principal investigator Dan C Nordstrom, MD, PhD
Description Product: Kineret (anakinra) Comparative agents: Methotrexate or azathioprine or leflunomide or cyclosporin A or sulphasalazine Protocol title: An open, randomized study treating refractory adult-onset Still's disease with IL-1ra anakinra (Kineret, compared to an established, single anti-rheumatic treatment Target Disease: Adult-onset Still's disease Patients: 23 patients diagnosed with AOSD, living in the four Nordic countries. Study Objectives: To follow the changes in clinical status and disease activity in patients receiving anakinra, compared to those treated with an established DMARD, in addition to corticosteroids in patients with refractory AOSD. To compare the changes in disease-related parameters (global health, patient's assessment on disease, laboratory values) in the two randomized groups. To assess the safety of anakinra in AOSD. To follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment in AOSD (open phase).
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Helsinki University.