By InvitationPhase 3

Interleukin-2 on Active Dermatomyositis

China240 participantsStarted 2022-12-01

Plain-language summary

The purpose of this paper is to explore the effect of low-dose IL-2 on refractory dermatomyositis and immunological indexes.

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18-75 years old (including 18 and 75 years old);
✓. The diagnosis of dermatomyositis conforms to Bohan/Peter Recommendation in 1975 or EULAR/ACR Classification Standard in 2017.
✓. The dose of glucocorticoid (equivalent to prednisone) was less than 0.5mg/kg/d within 4 weeks before joining the group, and/or there were no new immunosuppressants (cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, methotrexate, etc.) within 12 weeks, and the dose was stable for 4 weeks.
✓. Voluntary signing of informed consent: When participating in the trial, the patient must be given a written notice of consent, and hope that the patient can comply with the requirements of the study follow-up plan and other protocols.
✓. Agree to adopt effective contraceptive measures during the study period (women of childbearing age).

✕. Received intravenous glucocorticoid (\> 1 mg/kg/d) within 4 weeks;
✕. Serious complications: including (1). heart failure (≥ NYHA III); (2). renal insufficiency (creatinine clearance rate ≤30 ml/min); (3). liver insufficiency (excluding serum ALT or AST caused by dermatomyositis, or total bilirubin greater than normal upper limit), (4). hemoglobin \< 80g/L, E. platelet count \< 60.
✕. Dermatomyositis patients with other connective tissue diseases or tumors;
✕. Allergic constitution or allergic to multiple drugs;
✕. Those who are in the period of acute and chronic infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or are hospitalized for infection, or use intravenous antibiotics to treat infection 2 months before the first treatment, or have a history of active tuberculosis in the past;
✕. Those who are positive for hepatitis B surface antigen or hepatitis C antibody;
✕. Persons with mental illness or other reasons who cannot cooperate with treatment.

Proportion of subjects achieving minimal improvement (TIS≥20).

Timeframe: week 12

NCT IDNCT05495321

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18-75 years old (including 18 and 75 years old);
✓. The diagnosis of dermatomyositis conforms to Bohan/Peter Recommendation in 1975 or EULAR/ACR Classification Standard in 2017.
✓. The dose of glucocorticoid (equivalent to prednisone) was less than 0.5mg/kg/d within 4 weeks before joining the group, and/or there were no new immunosuppressants (cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, methotrexate, etc.) within 12 weeks, and the dose was stable for 4 weeks.
✓. Voluntary signing of informed consent: When participating in the trial, the patient must be given a written notice of consent, and hope that the patient can comply with the requirements of the study follow-up plan and other protocols.
✓. Agree to adopt effective contraceptive measures during the study period (women of childbearing age).

✕. Received intravenous glucocorticoid (\> 1 mg/kg/d) within 4 weeks;
✕. Serious complications: including (1). heart failure (≥ NYHA III); (2). renal insufficiency (creatinine clearance rate ≤30 ml/min); (3). liver insufficiency (excluding serum ALT or AST caused by dermatomyositis, or total bilirubin greater than normal upper limit), (4). hemoglobin \< 80g/L, E. platelet count \< 60.
✕. Dermatomyositis patients with other connective tissue diseases or tumors;
✕. Allergic constitution or allergic to multiple drugs;
✕. Those who are in the period of acute and chronic infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or are hospitalized for infection, or use intravenous antibiotics to treat infection 2 months before the first treatment, or have a history of active tuberculosis in the past;
✕. Those who are positive for hepatitis B surface antigen or hepatitis C antibody;
✕. Persons with mental illness or other reasons who cannot cooperate with treatment.