Study of Efficacy and Safety of canakinumab (ACZ885) in Patients With Adult Onset Still's Disease (AOSD)

JRCT ID: jRCT2011200022

Registered date:09/02/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Adult Onset Still's Disease (AOSD)
• Date of first enrollment: 30/03/2021
• Target sample size: 21
• Study type: Interventional
• Intervention(s): canakinumab administered subcutaneously every 4 weeks

Outcome(s)

• Primary Outcome: Proportion of participants who achieve adapted ACR 30 response at Week 8

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 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
2. Japanese male and female participants aged >= 16 years
3. 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:
Major criteria
- Fever >= 39 degree lasting 1 week or more
- Arthralgia lasting 2 weeks or more
- Typical skin rash: maculopapular, nonpruritic, salmon-pink rash with concomitant fever spikes
- Leukocytosis >=10,000/mm3 with neutrophil polymorphonuclear proportion >= 80%
Minor criteria
- Pharyngitis or sore throat
- Lymphadenopathy and/or splenomegaly
- Liver enzyme abnormalities
- Negative for RF or antinuclear antibodies
Exclusion criteria
- Infection, especially sepsis and Epstein-Barr viral infection
- Malignant diseases, especially malignant lymphomas
- Inflammatory disease, especially polyarteritis nodosa
4. Active disease at the time of baseline defined as follows
- Fever (body temperature > 38 degree) 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
5. Participants who have history of inadequate response to more than 2 weeks of corticosteroids equivalent to at least 0.4 mg/kg/day of prednisolone

Exclude criteria

1. History/evidence of active MAS or disseminated intravascular coagulation (DIC) prior to 6 months of enrollment.
2. With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator compromises the participant and/ or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
3. Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests at screening such as Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP)(must not exceed 3 times the upper limit value of the normal range for age), or serum bilirubin (must not exceed twice the upper limit value of the normal range for age).
4. 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.

Related Information

• Primary Sponsor: Yamada Hiroyuki
• Secondary ID(s): NCT04717635