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Completed

NCT Number: NCT01567358

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

392001001

Sendai, Miyagi, 982-0032, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • 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
  • Patients with active or latent tuberculosis or history of tuberculosis

Treatment and study plan

Infliximab

Biological

100mg/vial

Primary outcomes

  1. Safety : Incidence of Adverse Events

    Time frame: 14 weeks

Secondary outcomes

  1. PK : Area under the serum concentration versus time curve(AUC)

    Time frame: 14 weeks

  2. Efficacy : ACR core-set

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Nichi-Iko Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 30, 2012
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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