Refractory adult onset Still´s disease (AOSD)
Conditions
Interventions
Trade Name: Kineret 100 mg injection
Product Name: Kineret injection
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: anakinra
Concentration unit: mg milligram(s)
Conce
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 DMARD will be withdrawn for four weeks wash-out period Sign the informed consent.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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Finland, Sweden
Outcome results
None listed