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

Phase 1

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

Registration Number: EUCTR2005-003173-24-DK

Lead Sponsor: Sydvestjysk Sygehus

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

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 usind sufficient contraceptive/preventive precautions as determined by the investigator.
If usind 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 DMARD will be withdrawn for four weeks wash-out period.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.
Concerns 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 the study.