Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD

Launched by NOVARTIS PHARMACEUTICALS · Jan 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called canakinumab for people in Japan who have Adult Onset Still's Disease (AOSD). AOSD is a rare type of inflammatory arthritis that can cause symptoms like fever and painful joints. The trial involves giving participants canakinumab as an injection under the skin once every four weeks for at least 48 weeks. This study is currently active but not recruiting new participants at this time, and it aims to gather important information that may help approve this treatment for AOSD in Japan.

To be eligible for this study, participants must be at least 16 years old and have a confirmed diagnosis of AOSD, with active symptoms such as fever and swollen joints. They should not be pregnant or nursing, and they must not have certain medical conditions or infections that could put them at risk during the trial. Participants will receive regular care and monitoring throughout the study, and their experiences will help researchers understand how well the treatment works and if it is safe for patients with AOSD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent must be obtained prior to participation in the study. Parent's or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \< 20 years of age
• • Japanese male and female participants aged ≥ 16 years
• • Confirmed diagnosis of AOSD as per Yamaguchi criteria (Yamaguchi M, 1992) with an onset of disease ≥ 16 years of age. Yamaguchi criteria requires at least five criteria, including two major criteria and no exclusion criteria
• • Active disease at the time of baseline defined as follows
• • Fever (body temperature \> 38°C) due to AOSD for at least 1 day within 1 week before baseline
• • At least 2 active joints (tender or swollen)
• • CRP ≥ 10 mg/L
• Exclusion Criteria:
• • Pregnant or nursing (lactating) female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/ mL) at screening visit.
• • History of significant hypersensitivity to study drug or to biologics.
• • History/evidence of active macrophage activation syndrome or disseminated intravascular coagulation prior to 6 months of enrollment.
• • With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator compromises the articipant and/ or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
• • With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including participants with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
• • Participants with absolute neutrophil count \< 1500/mm3 at screening.