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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Helsinki University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT01033656
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 15, 2009
December 15, 2009
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adult-Onset Still's Disease
Drug: anakinra
100 mg subcutaneous injection daily
Other Name: Interleukin-1 receptor antagonist
Experimental: Anakinra
Intervention: Drug: anakinra
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.
 
Active, not recruiting
60
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01033656
NordicAOSD05, 2005-003173-24
No
Can C Nordstrom, MD, PhD, Helsinki University, Faculty of Medicine, Helsinki, Finland
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
December 2009

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