A Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's disease (AOSD) including an open-label long term extension.
- Conditions
- adult onset Still's disease (AOSD)MedDRA version: 20.0Level: PTClassification code 10042061Term: Still's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-001027-20-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method