We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study (NordicAOSD05)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01033656
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):

December 15, 2009
December 16, 2009
March 6, 2017
December 2005
March 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01033656 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study
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

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.

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).

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Adult-Onset Still's Disease
  • Drug: anakinra
    100 mg subcutaneous injection daily
    Other Name: Interleukin-1 receptor antagonist
  • Drug: comparators
    po drugs, comparators
    Other Name: methotrexate, azathioprine, leflunomide, sufalalazine
  • Experimental: Anakinra
    experimental drug of study
    Intervention: Drug: anakinra
  • Active Comparator: comparator
    comparators:methotrexate, azathioprine, leflunomide or supfasalazine
    Intervention: Drug: comparators
Nordström D, Knight A, Luukkainen R, van Vollenhoven R, Rantalaiho V, Kajalainen A, Brun JG, Proven A, Ljung L, Kautiainen H, Pettersson T. Beneficial effect of interleukin 1 inhibition with anakinra in adult-onset Still's disease. An open, randomized, multicenter study. J Rheumatol. 2012 Oct;39(10):2008-11. doi: 10.3899/jrheum.111549. Epub 2012 Aug 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2005-003173-24 ( Other Identifier: EudraCT )
Not Provided
Plan to Share IPD: No
Dan Nordstrom, Helsinki University
Helsinki University
  • Uppsala University Hospital
  • Helse Stavanger HF
  • Tampere University Hospital
  • Turku University Hospital
  • Oulu University Hospital
  • Kuopio University Hospital
  • Jyväskylä Central Hospital
  • Satakunta Central Hospital
  • University Hospital, Umeå
  • University Hospital, Linkoeping
Principal Investigator: Dan C Nordstrom, MD, PhD Helsinki University Hospital, Department of Medicine
Helsinki University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP