adult onset Still's disease (AOSD) MedDRA version: 20.0 Level: PT Classification code 10042061 Term: Still's disease System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Ilaris
Product Name: Canakinumab
Product Code: EU/1/09/564/004
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: A
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: written informed consent men and women = 18 years and = 75 years diagnosis of adult onset Still's disease according Yamaguchi et al. criteria (J Rheumatology 1992) disease activity (DAS28 >3,2) at Screening joint involvement defined as minimum 4 painfull and 4 swollen joints at Screening and Baseline (28 joint count) if treated with NSAID's: stable treatment for a minimum of 2 weeks prior to randomisation if treated with corticosteroids: stable treatment for a minimum of 1 week prior to randomisation (= 10 mg/ day) if on conventional DMARD therapy: stable treatment for a minimum of 6 weeks prior to randomisation washout of biologic DMARD's effective method for contraception 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: prior treatment with two or more doses of IMP intraarticular or intravenous injection with corticosteroids 4 weeks before randomisation treatment with narcotic analgetics (excluding permitted concomitant medications such as Tramadol and Codein) diagnosis of other, severe, chronic-inflammatory diseases positive hepatitis B Antigen (HBsAg), hepatitis C antibody and/ or HIV-antibody relevant active infection positive screening for latent tuberculosis (if patient is taking adequate/isoniazid prophylaxis for 4 weeks before first IP administration, this patient may be randomized.) elevated lab results: AST, ALT Bilirubin, Creatinine non adequate hematologic lab result history of neoplasm (with exception of curative treated non-melanoma neoplasm of the skin and carcinoma in situ of cervix) relevant cardial or pulmonary diseases macrophage activating syndrome (MAS) vaccination with life vaccine a history of alcohol or drug abuse within last 12 months blood donation or blood loss = 400 ml within last 8 weeks pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess efficacy of Canakinumab treatment for patients with adult onset Still's disease (AOSD) and active joint involvement according to proportion of patients with significant reduction of disease activity (DAS 28 [>1,2]) after 12 week treatment period Evaluation of the long-term safety of canakinumab in patients with AOSD and articular involvement;Secondary Objective: evaluation of safety of Canakinumab for patients with adult onset Still's disease (AOSD) evaluation of efficacy of Canakinumab for patients with AOSD and joint involvement according ACR response criteria at week 12 and week 24 proportion of patients who achieve a low disease activity (DAS28 < 3,2) or remission (DAS28 < 2,6) documentation of change in joint mobility to assess change in general health status using HAQ-DI and SF36-questionaire improvement of dermal Manifestation reduction of inflamatory lab values (CRP, ESR, Ferritin) Biomarker Analysis Description of the long-term efficacy of canakinumab in patients with AOSD according to EULAR response criteria (proportion of patients showing prolonged clinically improvement according to DAS28 low-disease activity [< 3.2] and remission [< 2.6], reduction of flares and glucocorticoid intake). Evaluation if a reduced dosage of canakinumab can be used to control disease activity;Primary end point(s): Disease activity score 28 Joints (DAS28);Timepoint(s) of evaluation of this end point: at Screening, Baseline and at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Joint manifestation: 1.DAS28 (Disease activity score) 2.ACR (American College of Rheumatology) Response Criteria and EULAR response criteria for low disease activity (DAS28 < 3.2) and remission (DAS28 < 2,6) Assessment of the level of disability and of quality of life: 1.Health Assessment Questionnaire Disability Index (HAQ-DI) 2.SF-36 health Survey Laboratory tests 1.Serological markers for inflammatory reactions (CRP, ESR, ferritin) 2.Immunogenity (anti-canakinumab antibodies) will be established at all visits, in the case of episodes of illness and with MAS. In the event of an anaphylactic reaction occurring, samples will be investigated following the injection and at intervals of 8 weeks. ;Timepoint(s) of evaluation of this end point: core-study: week 0, 4, 8, 12, 16, 20 and week 24 in long term extension phase (LTE): every 3 months (quarterly) up to visit month 30 safety evaluation (= secondary objective of core study and primary objective of LTE-phase): every month up to month 33 | — |
Countries
Germany
Contacts
Public ContactJan Zernicke
Charité - Universitätsmedizin Berlin
Outcome results
None listed