Canakinumab for Treatment of Adult-onset Still's Disease (NCT02204293) | Clinical Trial Compass
TerminatedPhase 2
Canakinumab for Treatment of Adult-onset Still's Disease
Stopped: Recruitment issues due to marketing authorization of study drug
Germany36 participantsStarted 2012-06-21
Plain-language summary
The purpose of this trial is to investigate the efficacy of the treatment with canakinumab in participants with Adult-onset Still's Disease (AOSD) and active joint involvement.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Written and signed consent from the participant to take part in the study
✓. Men and women aged ≥ 18 years and ≤ 75 years
✓. Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J. Rheumatology, 1992)
✓. Disease activity based on Disease Activity Score 28 (DAS28) of ≥3.2 at screening
✓. At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints according to DAS28)
✓. If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable dose for at least 4 weeks prior to randomisation
✓. If undergoing treatment with glucocorticoids, stable dose of ≤10 milligrams per day (mg/day) (prednisolone or equivalent) for at least 4 weeks prior to randomisation
✓. If undergoing treatment with conventional disease-modifying anti-rheumatic drugs (DMARD), stable dose for at least 3 months prior to randomisation
Exclusion criteria
✕. Previous treatment with the study drug with repeated administration of canakinumab
✕. Intraarticular or intravenous administration of glucocorticoids within 4 weeks prior to the baseline or use of narcotic analgesics except for analgesics permitted within the framework of the investigation (codeine and tramadol)
✕. Presence of another, serious chronic-inflammatory disease
What they're measuring
1
Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12