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

Primary Purpose

Adult-Onset Still's Disease

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
anakinra
comparators
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult-Onset Still's Disease focused on measuring adult-onset Still's disease, anakinra, prednisolone, disease-modifying antirheumatic drug, methotrexate, efficacy, patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ann Kataja Knight

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anakinra

comparator

Arm Description

experimental drug of study

comparators:methotrexate, azathioprine, leflunomide or supfasalazine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2009
Last Updated
March 3, 2017
Sponsor
University of Helsinki
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
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1. Study Identification

Unique Protocol Identification Number
NCT01033656
Brief Title
Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study
Acronym
NordicAOSD05
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult-Onset Still's Disease
Keywords
adult-onset Still's disease, anakinra, prednisolone, disease-modifying antirheumatic drug, methotrexate, efficacy, patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra
Arm Type
Experimental
Arm Description
experimental drug of study
Arm Title
comparator
Arm Type
Active Comparator
Arm Description
comparators:methotrexate, azathioprine, leflunomide or supfasalazine
Intervention Type
Drug
Intervention Name(s)
anakinra
Other Intervention Name(s)
Interleukin-1 receptor antagonist
Intervention Description
100 mg subcutaneous injection daily
Intervention Type
Drug
Intervention Name(s)
comparators
Other Intervention Name(s)
methotrexate, azathioprine, leflunomide, sufalalazine
Intervention Description
po drugs, comparators
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan C Nordstrom, MD, PhD
Organizational Affiliation
Helsinki University Hospital, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann Kataja Knight
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22859346
Citation
Nordstrom 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.
Results Reference
derived

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

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