Trials / Unknown
UnknownNCT04237987
Low-dose Interleukin-2 in Combination With Standard Therapy on Idiopathic Inflammatory Myopathy
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Low-dose Interleukin-2 in Combination With Standard Therapy Compared to Standard Therapy Alone in Adults With Active Idiopathic Inflammatory Myopathy
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Peking University People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) and cyclosporin a (CSA) on idiopathic inflammatory myopathy (IIM)
Detailed description
The investigators designed a radomized control study. Adults with active IIM will be enrolled. IIM is defined as Dermatomyositis (DM) or Polymyositis (PM), meeting the Bohan \& Peter (1975) diagnostic criteria for definite or probable DM or PM. Patients will be randomly divided into 2 groups arranged by registration order. One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously every other day for 3 months. All patients were followed up for 3 months after withdraw of IL-2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Interleukin-2 | Interleukin-2 was produced by Beijing Shuanglu Pharmaceutical Co., Ltd |
| DRUG | ciclosporin and corticosteroid | ciclosporin and corticosteroid |
Timeline
- Start date
- 2020-01-21
- Primary completion
- 2021-01-08
- Completion
- 2021-04-08
- First posted
- 2020-01-23
- Last updated
- 2020-01-23
Source: ClinicalTrials.gov record NCT04237987. Inclusion in this directory is not an endorsement.