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Low-dose Interleukin-2 in Polymyalgia Rheumatica
NCT04062006Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2019
- Primary completion
- Mar 2021
- Sponsor
- Peking University People's Hospital
- Modality
- Cytokines & Interferons
- Drugs
- aldesleukin
- Conditions
- polymyalgia rheumatica (PMR)
01
Overview
Phase 2, open-label, single-arm trial of aldesleukin in polymyalgia rheumatica (PMR), sponsored by Peking University People's Hospital. Primary endpoint: Percentage of Foxp3+Treg cells in total lymphocytes at 12 weeks. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Interleukin-2
Low-dose Aldesleukin added to stable background therapy.
03
Who it enrols
Patients aged 50 or older with Polymyalgia Rheumatica meeting 1986 Nancy recommendations, on stable glucocorticoids or DMARDs. Excludes those with Horton syndrome, recent high-dose steroids, serious infections, HIV, Hepatitis C, or malignancy within 5 years.
04
Endpoints
Primary
Percentage of Foxp3+Treg cells in total lymphocytes
Secondary
Physician's Global Disease Activity Visual Analog Scale
Patient's Global Disease Activity Visual Analog Scale
Incidence of adverse events
36-item Short Form Health Survey
Proportion of patients with Low disease activity (PMR-AS<10) with steroid independence
Cumulative dosages of glucocorticoids
Proportion of patients with PMR-activity score (AS) < 1.5; 10; 17
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