Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）
Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome
1 other identifier
interventional
6
1 country
1
Brief Summary
The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human Interleukin-2 （rhIL-2） for MAS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 6, 2015
October 1, 2015
3.5 years
October 2, 2015
October 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS
1month
Study Arms (1)
Low-does rhIL-2 therapy
EXPERIMENTALRecombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks
Interventions
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of Macrophage Activation Syndrome（MAS）
- MAS secondary to autoimmune disease, such as Adult onset still's disease (AOSD), juvenile rheumatoid arthritis (JRA) or Systemic Lupus Erythematosus (SLE).
You may not qualify if:
- Primary MAS
- Secondary to neoplasia, lymphoma and virus infection
- pre-treatment with Cyclosporine A
- relevant cardiac, pulmonary, neurologic or psychiatric disease
- life-Vaccination within 4 weeks before begin with study medication
- pregnant or breast-feeding
- weight under 45kg or more than 80kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Li
Department of Rheumatology and Immunology,Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 6, 2015
Study Start
June 1, 2014
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
October 6, 2015
Record last verified: 2015-10