NCT04062006

Low-dose Interleukin-2 Treatment on Polymyalgia Rheumatica

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) on polymyalgia rheumatica.

Detailed description

The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines. One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously five days every week for 4 weeks and then once a week for 8 weeks. All patients were followed up for 3 months after treatment.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Interleukin-2	low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU/m2 five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).

Timeline

• Start date: 2019-08-31
• Primary completion: 2021-03-31
• Completion: 2021-06-30
• First posted: 2019-08-20
• Last updated: 2019-09-04