Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis
Status:
Completed
Trial end date:
2017-08-31
Target enrollment:
Participant gender:
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)).
Phase:
Phase 2
Details
Lead Sponsor:
Peking University People's Hospital
Collaborators:
Beijing ShuangLu Pharmaceutical Co., Ltd. Monash University
Treatments:
Antirheumatic Agents Folic Acid Loxoprofen Vitamin B Complex