Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01567358

Enrollment

Registered

2012-03-30

Start date

2012-02-29

Completion date

2013-04-30

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.

Interventions

BIOLOGICALInfliximab

100mg/vial

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months 2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg\ 16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit

Exclusion criteria

1. History of following diseases * Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment * Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.） * Severe infectious disease（hepatitis, pneumonia、sepsis） * History of demyelinating disease or multiple sclerosis * Congestive heart failure * lymphoproliferative disorder or myelodysplastic syndrome * History of malignancy * Interstitial lung disease 2. Patients with active or latent tuberculosis or history of tuberculosis

Design outcomes

Primary

Measure	Time frame
Safety : Incidence of Adverse Events	14 weeks

Secondary

Measure	Time frame
PK : Area under the serum concentration versus time curve(AUC)	14 weeks
Efficacy : ACR core-set	14 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026