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

NCT02467504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-09-09

Study results available
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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)).

Conditions

Interventions

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)

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Beijing ShuangLu Pharmaceutical Co., Ltd.

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Zhanguo Li, MD PhD · Peking University Institute of Rheuamotology and Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2017-01-15
Completion
2017-08-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467504 on ClinicalTrials.gov