Single-arm, open-label pilot intervention study to investigate an effect of oral 5-aminolevulinic acid plus sodium ferrous citrate on glucocorticoid reduction in patients with adult-onset Still's disease: Study protocol for clinical trial (SPIRIT Compliant)

JRCT ID: jRCTs071190042

Registered date:14/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult-onset Still's disease
• Date of first enrollment: 12/02/2020
• Target sample size: 7
• Study type: Interventional
• Intervention(s): 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 of oral prednisolone should be reduced according to the prescribed protocol to determine whether relapse/exacerbation has occurred.

Outcome(s)

• Primary Outcome: Number of study participants who are able to maintain prednisolone reduction without relapse/ exacerbation after study initiation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kawakami Atsushi
• Source(s) of Monetary Support: Neopharma Japan CO.LTD