Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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.

Arms:
arm 1: hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen arm 2: hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen

Interventions: intervention 1: hrIL-2 active intervention 2: hrIL-2 placebo intervention 3: MTX intervention 4: Folic Acid intervention 5: Loxoprofen
Intervention descriptions: intervention 1: hrIL-2 active (1 million U doses of hrIL-2s.c.injection) intervention 2: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection) intervention 3: Methotrexate (oral administration) intervention 4: Folic Acid (oral administration) intervention 5: Loxoprofen (oral administration)

Protocol document: