Adult-onset Still's disease
Conditions
Interventions
Patients with AOSD who continue to receive the same dose of oral prednisolone for at least 8 weeks receive an additional 16 weeks of 5-ALA/SFC. At 4 and 10 weeks after the start of the study, the dose
Sponsors
Kawakami Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with 20 years older at the time of obtaining informed consent 2.Hospitalization/Outpatient, Outpatient only 3.Adult onset still's disease patients who met Yamaguchi's criteria (1992) at diagnosis 4.Patients under treatment with oral prednisolone at dose of 5 mg/day or more and 30 mg/day or less 5.Patients who have been treated with the same dose of oral prednisolone for at least 8 weeks prior to the start of administration, and had not received new or changed doses of other immunosuppressive drugs or biologics for at least 8 weeks 6.Patients who give written informed consent after receiving sufficient information
Exclusion criteria
Exclusion criteria: 1.Patients classified as severe according to the AOSD severity classification prepared by the Research Group of the Ministry of Health, Labor and Welfare, Japan 2.Patients who have previously taken 5-ALA/SFC 3.Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the study period and lactating women. Men who will not be compliant with a contraceptive regimen during the study period 4.Patients judged as inappropriate for any other reason by the clinical investigator or clinical trial physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of study participants who are able to maintain prednisolone reduction without relapse/ exacerbation after study initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical signs at 0, 4 weeks, 10 weeks, 16 weeks, and discontinuation (fever, joint symptoms, rash, and enlarged lymph nodes) Abnormalities in laboratory test (WBC, Hb, Plt, CRP, and ESR) based on the Systemic feature score at 0, 4 weeks, 10 weeks, 16 weeks, and termination Systemic feature score at 0, 16 weeks, and discontinuation Changes in physician's VAS at 0, 4 weeks, 10 weeks, 16 weeks, and termination Changes in patients' VAS at 0, 4 weeks, 10 weeks, 16 weeks, and termination Changes in test values (WBC, Hb, Plt, CRP, ESR, ferritin) from the start of administration at 0, 4 weeks, 10 weeks, 16 weeks, and termination | — |
Contacts
Public ContactTomohiro Koga
Nagasaki University Graduate School of Biomedical Sciences
Outcome results
None listed