NCT02467504

Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis

A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Several immunomodulating agents have been attempted in the treatment of RA without achieving satisfactory results. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RA patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2 (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).

Detailed description

Each RA patients (n=47) with DAS\>3.2 received low-dose IL-2+MTX+ Loxoprofen or placebo+MTX + Loxoprofen (active group: placebo group =1:1, 1 million units every other day subcutaneously (hrIL-2 1×106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	hrIL-2 active	hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
DRUG	hrIL-2 placebo	hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
DRUG	MTX	Methotrexate (oral administration)
DRUG	Folic Acid	Folic Acid (oral administration)
DRUG	Loxoprofen	Loxoprofen (oral administration)

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-01-15
• Completion: 2017-08-31
• First posted: 2015-06-10
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

1 site across 1 country: China