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
  Purpose

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.


Condition Intervention Phase
Adult-Onset Still's Disease
Drug: anakinra
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Helsinki University:

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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2005
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra Drug: anakinra
100 mg subcutaneous injection daily
Other Name: Interleukin-1 receptor antagonist

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033656

Locations
Sweden
Ann Kataja Knight
Uppsala, Sweden, 75185
Sponsors and Collaborators
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
Investigators
Principal Investigator: Dan C Nordstrom, MD, PhD Helsinki University Hospital, Department of Medicine
  More Information

No publications provided by Helsinki University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Can C Nordstrom, MD, PhD, Helsinki University, Faculty of Medicine, Helsinki, Finland
ClinicalTrials.gov Identifier: NCT01033656     History of Changes
Other Study ID Numbers: NordicAOSD05, 2005-003173-24
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: European Union: European Medicines Agency
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
adult-onset Still's disease
anakinra
prednisolone
disease-modifying antirheumatic drug
methotrexate
efficacy
patients

Additional relevant MeSH terms:
Still's Disease, Adult-Onset
Arthritis, Juvenile
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Interleukin 1 Receptor Antagonist Protein
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014