An open, randomized study treating refractory adult-onset Still´s disease (AOSD) with interleukin-1 receptor antagonist anakinra (KineretR), compared to an established, single anti-rheumatic drug treatment. - AOSD Study 05

Conditions: Refractory adult onset Still´s disease (AOSD)

Registration Number: EUCTR2005-003173-24-FI

Lead Sponsor: Helsinki University Central Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 72

Inclusion Criteria

Be diagnosed with AOSD according to the preliminary classification by Yamaguchi, 1992.
Be considered refractory to corticosteroids and/or DMARD´s. Refractory state is defined as the need for prednisolone equivalent doses exceeding 10 mg/day with or without concomitant use of DMARD, and unacceptable disease activity determined by the investigator.
Be = 18 years of age at the time of consent.
If woman, be non-pregnant. Both female and male patients must be using sufficient contraceptive/preventive precautions as determined by the investigator.
If using NSAIDs and oral corticosteroid, doses must have been kept stable for = 2 weeks before screening.
If using conventional DMARD, doses must have been kept stable for = 4 weeks before screening. DMARD will be withdrawn for four weeks wash-out period
Sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of corticosteroids prednisolone equivalent below or equal to 10 mg daily.
Pregnant or breast-feeding women.
Female or male patients not using adequate contraceptive/preventive precautions as determined by the investigator.
Total white cell count < 2.0 x 10 9/L, a neutrophil count of < 1.0 x 10/L, or a platelet count < 100 x 10 /L.
Elevated serum creatinine (=1.5 x upper limit of normal).
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.
Known allergy to E coli-derived products.
Concern for patient´s compliance with the protocol procedures.
Enrollment in another concurrent clinical study, or intake of an investigational drug, within three months prior to inclusion in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess and to compare the changes in disease-related parametres (global health, patient’s assessment on disease, laboratory values) in the two randomized groups. To assess the safety of anakinra in AOSD.;Primary end point(s): Proportion of patients reaching remission of the disease after two months of the study treatment (stated as afebrile [=< 37°C of body temperature] and acute phase reactants [C-reactive protein, ferritin] within normal limits).;Main Objective: To follow the changes in clinical status and disease activity in patients receiving anakinra, compared to those treated with an established, single anti-rheumatic agent (methotrexate or azathioprine or leflunomide or cyclosporin A or sulphasalazine), in addition to corticosteroids in patients with refractory adult onset Still’s disease (AOSD).

Secondary Outcome Measures