Adult-Onset Still's Disease
Conditions
Keywords
adult-onset Still's disease, anakinra, prednisolone, disease-modifying antirheumatic drug, methotrexate, efficacy, patients
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).
Interventions
DRUGanakinra
100 mg subcutaneous injection daily
DRUGcomparators
po drugs, comparators
Sponsors
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
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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) | 8 weeks |
Countries
Sweden
Outcome results
None listed