Interleukin-2 on Active Dermatomyositis

Официальное название

Therapeutic Effect of Interleukin-2 on Active Dermatomyositis: A Multicenter, Randomised, Double-blind, Placebo-controlled Trial

Обзор

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

Подробное описание

A randomized, double-blind, placebo-controlled, multicenter clinical trial was designed. Patients were treated with low-dose IL-2 regularly to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.

Вмешательства

• Препарат Interleukin-2
  low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once every other day, for 6 months.

Первичные конечные точки

• Proportion of subjects achieving minimal improvement (TIS≥20). [Срок оценки: week 12]

Вторичные конечные точки (12)

• MMT-8 (Manual Muscle Testing), (potential score 0 - 80); [Срок оценки: week12 and 24]
• CDASI activity score (cutaneous dermatomyositis disease area and severity index), (potential score 0-100 for cutaneous dermatomyositis disease area and 0-32 for severity index); [Срок оценки: week12 and 24]
• Physician's Global Disease Activity VAS, (potential score 0 - 10); [Срок оценки: week12 and 24]
• Patient's Global Disease Activity VAS, (potential score 0 - 80); [Срок оценки: week 12 and 24]
• Health assessment question, (potential score 0 - 3); [Срок оценки: week 12 and 24]
• Myositis disease activity assessment tool (MDAAT) - 2005, VERSION 2 [Срок оценки: week 12 and 24]
• CD4 T cells [Срок оценки: week 12 and 24]
• Serum cytokines [Срок оценки: week 12 and 24]
• glucocorticoid dosage [Срок оценки: week 12 and 24]
• Rate of Participants with adverse effects associated with experimental drugs [Срок оценки: up to 24 weeks]
• Proportion of subjects meeting the definition of improvement (DOI) [Срок оценки: week12 and 24]
• Number of subjects achieving minimal improvement (TIS≥20). [Срок оценки: week 24]

Критерии участия

Критерии включения

• 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.

Active myositis was defined by baseline Manual Muscle Testing (MMT-8) no greater than 125/150 and at least two additional abnormal CSMs. To allow the enrolment of patients with active DM with a moderate to severe rash who may not meet the MMT-8 criterion noted above, patients with DM could be enrolled if their cutaneous VAS score on the Myositis Disease Activity Assessment Tool (MDAAT) was ≥3cm on the 10cm VAS scale and at least three of the five CSMs were abnormal (excluding the MMT-8).

Abnormal CSMs include:

• 1\. patients global assessment (PGA), the minimum value of 10 cm visual analog scale (VAS) is 2.0 cm
• 2\. Physicians global assessment (PhGA), the minimum value on the 10 cm VAS scale is 2.0 cm
• 3\. Health Assessment Questionnaire (HAQ), with a minimum value of 0.25
• 4\. At least one muscle enzyme \[including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\] High, the lowest level is 1.3 x upper limit normal
• 5\. Global Extra-muscle Disease Activity Score, with a minimum of 1.0 cm on the 10 cm VAS scale \[This measure is a comprehensive assessment by the physician based on an assessment of the physique, skin, bone, gastrointestinal, lung and heart scale activity scores,named Myositis Disease Activity Assessment Tool (MDAAT)\].
• 6\. Manual Muscle Testing (MMT-8) no greater than 125/150.
• 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).

Критерии исключения

Any subject meeting any of the following criteria should be excluded:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking university people's hospital — Пекин

Идентификаторы

NCT: NCT05495321 · IIMIL2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗