A Phase 3 interventional study of Interleukin-2 in Dermatomyositis, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Peking University People's Hospital · Phase 3, Interventional, and Treatment
The purpose of this paper is to explore the effect of low-dose IL-2 on refractory dermatomyositis and immunological indexes.
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.
175 studies on the registry are indexed under Dermatomyositis; 62 are open to participants now.
This study's planned enrollment of 240 is above the median of 34 across 127 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
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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:
Exclusion Criteria:
Any subject meeting any of the following criteria should be excluded:
The first stage (double-blind treatment period): One million IU of IL-2 was injected subcutaneously once every other day for 12 weeks. The second stage (open treatment period): One million IU of IL-2 was injected subcutaneously once every other day for 12 weeks.
Drug: Interleukin-2
The first stage (double-blind treatment period): Placebo was injected subcutaneously once every other day for 12 weeks. The second stage (open treatment period): One million IU of IL-2 was injected subcutaneously once every other day for 12 weeks.
Drug: Interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once every other day, for 6 months.
Also known as: Recombinant Human Interleukin-2
Proportion of subjects achieving minimal improvement (TIS≥20).
The primary outcome will be to compare the proportion of subjects achieving minimal improvement (TIS≥20). The TIS (total improvement score) is the sum of all 6 improvement scores associated with the change in each core set measure. A total improvement score of ≥20 represents minimal improvement, a score of ≥40 represents moderate improvement, and a score of ≥60 represents major improvement.
Time frame: week 12
MMT-8 (Manual Muscle Testing), (potential score 0 - 80);
MMT-8 is a set of 8 designated muscles tested unilaterally; test on right side (use left side if right side cannot be tested). Higher scores mean a better outcome.
Time frame: 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);
The CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM patients for use in clinical practice or clinical/therapeutic studies. Higher scores mean a worse outcome.
Time frame: week12 and 24
Physician's Global Disease Activity VAS, (potential score 0 - 10);
Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
Time frame: week12 and 24
Patient's Global Disease Activity VAS, (potential score 0 - 80);
Patient's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
Time frame: week 12 and 24
Health assessment question, (potential score 0 - 3);
Patients reported how their illness affects their ability to function in daily life , Higher scores mean a better outcome.
Time frame: week 12 and 24
Myositis disease activity assessment tool (MDAAT) - 2005, VERSION 2
This is a combined tool that captures the physician's assessment of disease activity of various organ systems using (1) the 0-4 scale described below and (2) a visual analog scale (VAS) \[potential score 0 - 10\]. Please assess the clinical features (items 1-26) of each organ system. Higher scores mean a worse outcome.
Time frame: week 12 and 24
CD4 T cells
number and proportion of CD4 T cells in peripheral blood.
Time frame: week 12 and 24
Serum cytokines
concentration of serum cytokines
Time frame: week 12 and 24
glucocorticoid dosage
Daily dosage of glucocorticoid
Time frame: week 12 and 24
Rate of Participants with adverse effects associated with experimental drugs
Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy.
Time frame: up to 24 weeks
Proportion of subjects meeting the definition of improvement (DOI)
The DOI for this trial is a composite utilizing the six CSM: 3 of 6 CSM improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (a worsening measure cannot be the MMT).
Time frame: week12 and 24
Number of subjects achieving minimal improvement (TIS≥20).
The primary outcome will be to compare the proportion of subjects achieving minimal improvement (TIS≥20). The TIS (total improvement score) is the sum of all 6 improvement scores associated with the change in each core set measure. A total improvement score of ≥20 represents minimal improvement, a score of ≥40 represents moderate improvement, and a score of ≥60 represents major improvement.
Time frame: week 24
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interleukin-2
Peking University People's Hospital →