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

March 3, 2017 updated by: Dan Nordstrom, University of Helsinki

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Ann Kataja Knight

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anakinra
experimental drug of study
Drug: anakinra
100 mg subcutaneous injection daily
Other Names:
  • Interleukin-1 receptor antagonist
Active Comparator: comparator
comparators:methotrexate, azathioprine, leflunomide or supfasalazine
Drug: comparators
po drugs, comparators
Other Names:
  • methotrexate, azathioprine, leflunomide, sufalalazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Turku University Hospital
Oulu University Hospital
Kuopio University Hospital
Helse Stavanger HF
University Hospital, Linkoeping
Tampere University Hospital
University Hospital, Umeå
Uppsala University Hospital
Satakunta Central Hospital
Jyväskylä Central Hospital

Investigators

  • Principal Investigator: Dan C Nordstrom, MD, PhD, Helsinki University Hospital, Department of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NordicAOSD05
  • 2005-003173-24 (Other Identifier: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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